BADANIA KLINICZNE PROWADZONE W POLSCE

BK 1 fazy Niraparib+ABI podawane w różnych sekwencjach w mCR

Nieprzeczytany postautor: zosia bluszcz » 23 kwie 2021, 02:42

REKRUTACJA ZAKONCZONA


An Open-label, Randomized Study to Assess the Relative Bioavailability (BA) and Bioequivalence (BE) of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer - NCT04577833

https://clinicaltrials.gov/ct2/show/NCT04577833
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BK fazy 1/2 MGC018 + Retifanlimab (MGA012) w mCRPC (m.in.)

Nieprzeczytany postautor: zosia bluszcz » 23 kwie 2021, 03:02

REKRUTACJA ZAKONCZONA


A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of MGC018 (Anti-B7-H3 Antibody Drug Conjugate) Alone and in Combination With MGA012 (Anti-PD-1 Antibody) in Patients With Advanced Solid Tumors - NCT03729596



Retifanlimab (previously known as MGA012) is an investigational, humanized, proprietary anti-PD-1 monoclonal antibody being developed for use as monotherapy as well as in combination with other potential cancer therapeutics. Retifanlimab was licensed to Incyte Corporation in 2017 under a global collaboration and license agreement
https://www.macrogenics.com/mga012-pd-1/


MGC018 (B7-H3)
MGC018 is an investigational antibody-drug conjugate (ADC) comprised of a humanized B7-H3 monoclonal antibody (mAb) conjugated via a cleavable linker to the prodrug seco-DUocarmycin hydroxyBenzamide Azaindole (DUBA; licensed from Byondis, B.V.), with an average drug-to-antibody ratio (DAR) of ~2.7. DUBA is an alkylating agent that can damage DNA in both dividing and non-dividing cells, causing cell death. MGC018 is designed to target solid tumors expressing B7-H3.

https://www.macrogenics.com/mgc018-b7-h3/


Incyte Announces the Validation by the European Medicines Agency of its Marketing Authorization Application for Retifanlimab as a Treatment for Patients with Squamous Cell Anal Carcinoma (SCAC)
https://www.businesswire.com/news/home/ ... inoma-SCAC


FDA Grants Priority Review for Retifanlimab for Advanced Squamous Cell Carcinoma of the Anal Canal
https://www.targetedonc.com/view/fda-gr ... anal-canal
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Cabozatinib+Atezolizumab vs Second NHT (ABI/ENZ) in mCRPC

Nieprzeczytany postautor: zosia bluszcz » 07 wrz 2021, 11:00

REKRUTACJA ZAKONCZONA


A Phase 3, Randomized, Open-Label, Controlled Study of Cabozantinib (XL184) in Combination With Atezolizumab vs Second Novel Hormonal Therapy (NHT) in Subjects With Metastatic Castration-Resistant Prostate Cancer - CONTACT-02 - NCT04446117

[https://clinicaltrials.gov/ct2/show/results/NCT04446117
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Zast. MGD019 DART® Protein u pacjentów z nieop. lub mCRPC

Nieprzeczytany postautor: zosia bluszcz » 07 wrz 2021, 23:37

W uproszczeniu - zadaniem MDG019 jest wzmocnienia przeciwnowotworowej odpowiedzi układu odpornościowego.



W pierwszej fazie badania MDG019 był podawany, między innymi, pacjentom z mCRPC z 18 pacjentów, którzy mogli być ewaluowani, 4 odpowiedziało na leczenie, w tym 1 pacjent z rakiem prostaty - potwierdzona całkowita remisja.



REKRUTACJA ZAKOŃCZONA


A Phase 1, First-in-Human, Open-Label, Dose Escalation and Cohort Expansion Study of MGD019, a Bispecific DART® Protein Binding PD-1 and CTLA-4 in Patients With Unresectable or Metastatic Neoplasms

https://clinicaltrials.gov/ct2/show/NCT03761017





Wyniki drugiego etapu pierwszej fazy (czyli eskalacji dawki) zostaly omówione w artykule z września 2020.


Sep 20, 2020
MacroGenics Announces Presentation of MGD019 Phase 1 Data at the ESMO Virtual Congress 2020

=> MGD019 well-tolerated with early signals of activity in advanced solid tumors not typically responsive to checkpoint inhibition
=> Recommended Phase 2 dose established for MSS CRC, NSCLC expansion cohorts
(...)
MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced clinical data from the dose escalation portion of a Phase 1 clinical trial of MGD019.
The proffered paper session titled, “A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of MGD019, an Investigational Bispecific PD-1 × CTLA-4 DART® Molecule in Patients with Advanced Solid Tumors,” was presented orally at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 on September 20, 2020, by Dr. Manish R. Sharma, Associate Director of Clinical Research at START Midwest in Grand Rapids, Michigan.

MGD019, a bispecific PD-1 × CTLA-4 DART molecule, was designed to enhance CTLA-4 blockade on dual-expressing, tumor-infiltrating lymphocytes compared to a PD-1/CTLA-4 monoclonal antibody (mAb) combination therapy, while maintaining maximal PD-1 blockade on all PD-1-expressing cells.

Forty-three patients were enrolled in the Phase 1 dose escalation study of MGD019 within a dose range of 0.03 – 10.0 mg/kg, administered every three weeks initially, in a population of heavily pre-treated patients representing a broad range of different types (23) of solid tumors.
There were no dose-limiting toxicities (DLTs).
A total of 28 patients were treated at doses ≥ 3.0 mg/kg administered every three weeks initially.
MGD019 was well-tolerated in patients who received less than 10 mg/kg; the most common treatment-related adverse events over this dosing range were pruritus (23.3%), arthralgia (18.6%), fatigue (18.6%), rash (18.6%), nausea (16.3%) and infusion-related reaction (16.3%). Several Grade 3 adverse events were observed at the 10.0 mg/kg level; however, none were considered dose limiting.
(...)
Of the 18 evaluable patients who received doses ≥ 3.0 mg/kg as of the July 21, 2020 cut-off date, four objective responses have been reported in this trial, including a confirmed complete response in metastatic castration-resistant prostate cancer (mCRPC), confirmed partial responses in microsatellite stable colorectal cancer (MSS CRC) and metastatic type AB thymoma, and an unconfirmed partial response in serous fallopian tube carcinoma.
(...)

http://ir.macrogenics.com/news-releases ... -data-esmo
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PROCADE HC-1119 vs Enzalutamid w mCRPC (przed CHT!)

Nieprzeczytany postautor: zosia bluszcz » 20 lis 2021, 08:53

NA TYM ETAPIE BADANIE KLINICZNE PROCADE PROWADZI REKRUTACJĘ WYŁĄCZNIE W LUBLINIE


PROCADE: A Multinational Phase 3, Randomized, Double-Blind, Non-inferiority, Efficacy and Safety Study of Oral HC-1119 Versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC) NCT03850795



Inclusion Criteria:

Subjects must meet the following inclusion criteria:
=> Age 18 or older and willing and able to give informed consent.
=> Histologically or cytologically confirmed adenocarcinoma of the prostate without significant and relevant neuroendocrine differentiation or small cell features, per investigator's judgment.
=> Ongoing ADT with a GnRH analogue, antagonist or bilateral orchiectomy (i.e., surgical or medical castration).
=> For patients who have not had a bilateral orchiectomy, there must be a plan to maintain effective GnRH analogue or antagonist therapy for the duration of the trial.
=> Serum testosterone level < 1.7 nmol/L (50 ng/dL) at the Screening visit.
=> Patients receiving bisphosphonate or denosumab therapy must have been on stable doses for at least four weeks (from Day 1 visit).
=> Progressive disease at study entry defined as one or more of the following three criteria that occurred while the patient was on ADT as defined in eligibility criterion #3:
=> PSA progression defined by a minimum of two rising PSA levels with an interval of ≥ 1 week between each determination. Patients who received an anti-androgen agent must have progression after withdrawal (≥ 4 weeks since last flutamide or ≥ 6 weeks since last bicalutamide or nilutamide). The PSA value at the => Screening visit should be ≥ 2 µg/L (2 ng/mL)
=> Soft tissue disease progression defined by RECIST 1.1
=> Bone disease progression defined by PCWG3 with two or more new lesions on bone scan
=> Metastatic disease documented by measurable soft tissue disease by CT/MRI per RECIST 1.1 criteria. Patients are allowed to have any metastatic disease (i.e. bone metastasis) as long as they also have measurable soft tissue lesions per RECIST 1.1..
=> No prior cytotoxic chemotherapy for prostate cancer.
=> Asymptomatic or mildly symptomatic from prostate cancer.
=> ECOG performance status of 0-1 per the Investigators' clinical assessment
=> Estimated life expectancy of ≥ 6 months
=> Able to swallow the study drug and comply with study requirements
=> All sexually active patients are required to use a condom as well as meet 1 of the following:
=> Patient is non-fertile (orchiectomy) or has a female partner of non-childbearing potential (i.e., post-menopausal, surgically sterilized, hysterectomy)
=> Patient and his female partner must agree to use an adequate contraceptive method from the first day of dosing until 3 months after the last dose to prevent pregnancies. Adequate contraceptive method is defined as:
i. Established use of oral, injected, or implanted hormonal methods of contraception.
ii. Placement of an intra-uterine device or intra-uterine system. iii. Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
iv. Tubal ligation for at least 6 months prior to screening.
=> Male patient engaged in sexual activity with a pregnant female is required to use a condom from the first day of dosing until 3 months after the last dose of treatment with study drugs.



Exclusion Criteria:

Subjects must NOT meet any of the following exclusion criteria:
=> Severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment.
=> Known or suspected brain metastasis or active leptomeningeal disease.
=> Regular daily use of opiate analgesics for pain from prostate cancer within four weeks of enrolment (Day 1 visit).
=> WBC count < 3,000/µL, or absolute neutrophil count < 1,500/µL, or platelet count < 100,000/µL, or hemoglobin < 5.6 mmol/L (9 g/dL) at the Screening visit (NOTE: patients may not have received any growth factors or blood transfusions or any therapeutic invention within 14 days of the hematologic laboratory values obtained at the Screening visit).
=> Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal at the Screening visit; no therapeutic invention within 14 days before screening.
=> Creatinine clearance < 30 mL/min as calculated using the Cockcroft-Gault equation at the Screening visit. Creatinine Clearance (mL/min) = [[140-Age (years)] * Weight (kg)] / [72 * Serum Creatinine (mg/dL)]
=> Albumin < 30 g/L (3.0 g/dL) at the Screening visit, no therapeutic invention within 14 days before screening.
=> History of another malignancy within the previous two years other than curatively treated non-melanomatous skin cancer.
=> Treatment with flutamide within four weeks of enrolment (Day 1 visit).
=> Treatment with bicalutamide or nilutamide within six weeks of enrolment (Day 1 visit).
=> Treatment with 5-α reductase inhibitors (finasteride, dutasteride), estrogens within four weeks of enrolment (Day 1 visit).
=> Treatment with systemic biologic therapy for prostate cancer (other than approved bone targeted agents) within four weeks of enrolment (Day 1 visit).
=> Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone/prednisolone per day within four weeks of enrolment (Day 1 visit).
=> Prior use, or participation in a clinical trial, of an agent that blocks androgen synthesis (e.g., abiraterone) or blocks the AR (e.g., apalutamide, darolutamide, enzalutamide, proxalutamide).
=> Participation in a previous clinical trial of HC-1119.
=> Use of an investigational agent within four weeks of enrolment (Day 1 visit).
=> Radiation therapy for treatment of the primary tumor within three weeks of enrolment (Day 1 visit).
=> Radionuclide therapy (Radium 223) for treatment of metastasis within four weeks of enrolment (Day 1 visit).
=> Clinically significant cardiovascular disease or condition
=> Treatment with strong CYP2C8 inhibitors and inducers, CYP3A4 inducers, medications which are known to prolong the QT interval (see Appendix C).
=> History of seizure or any condition that may predispose to seizure.
=> Conditions that predispose subjects to increased risk for falls or fractures according to the discretion of the Investigator.
=> Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease within last three months).
=> Major surgery within four weeks prior to enrolment (Day 1 visit).
=> Have active infection with HBV measured by hepatitis B surface antigen (HBsAg) test, HCV measured by RNA test and HIV measured by antibody test.
=> Have known active tuberculosis.
=> Known hypersensitivity to HC-1119, enzalutamide, or any of the excipients.
=> Rare hereditary problems of fructose intolerance due to sorbitol


Poland

Onko-Centrum Sp. z o.o. Recruiting
Lublin, Poland, 20-250
Contact: Pawel Iberszer +48601813454 piberszer@gmail.com

https://clinicaltrials.gov/ct2/show/NCT03850795




[color=#8000BF]____________EDIT (03/12/2021______________
FYI

HC-1119 = deuterowany enzalutamid

Lek deuterowany to drobnocząsteczkowy produkt leczniczy, w którym jeden lub więcej atomów wodoru zawartych w cząsteczce leku zostało zastąpionych jego cięższym, stabilnym izotopem deuteru.
Ze względu na kinetyczny efekt izotopowy, leki zawierające deuter mogą mieć znacznie niższe tempo metabolizmu, a tym samym dłuższy okres półtrwania.
-zb
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KEYNOTE-365 Pembrolizumab w połączeniu innymi lekami w mCRPC

Nieprzeczytany postautor: zosia bluszcz » 03 gru 2021, 15:09

BADANIE KLINICZNE KEYNOTE-365 W DALSZYM CIĄGU PROWADZI REKRUTACJĘ



KEYNOTE-365:
Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) NCT02861573



Brief Summary:
The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combination therapy in patients with metastatic castrate resistant prostate cancer (mCRPC). There will be nine cohorts in this study:

Cohort A will receive pembrolizumab + olaparib,
Cohort B will receive pembrolizumab + docetaxel + prednisone,
Cohort C will receive pembrolizumab + enzalutamide,
Cohort D will receive pembrolizumab + abiraterone + prednisone
Cohort E will receive pembrolizumab + lenvatinib,
Cohort F will receive pembrolizumab + lenvatinib,
Cohort G will receive pembrolizumab/vibostolimab coformulation (MK-7684A),
Cohort H will receive pembrolizumab/vibostolimab coformulation, and
Cohort I will receive pembrolizumab + carboplatin + etoposide in Arm 1 and carboplatin + etoposide in Arm 2.


Criteria

Inclusion Criteria:

=> For Cohorts A, B, C, D, E, G: Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology

=> For Cohorts F, H, I:
Has t-NE prostate cancer defined by ≥1% neuroendocrine cells in a recent biopsy specimen from a metastasis as determined by the investigational site and confirmed by central histology review prior to enrolment

=> Is able to provide tumor tissue from a site not previously irradiated as follows:
> Cohorts A, E, and G: must provide a core or excisional biopsy from soft tissue or bone biopsy within 1 year of screening and after developing mCRPC;
> Cohort B: must provide an archival tumor tissue sample or tumor tissue from a newly obtained core or excisional biopsy from soft tissue if the lesion is clinically accessible;
> Cohorts C and D with soft tissue disease: must provide a core or excisional biopsy from a soft tissue lesion if clinically accessible within 1 year of screening and after developing mCRPC and an archival specimen if available; and
> Cohorts F, H, and I must provide a core or excisional biopsy from soft tissue or a bone biopsy.

Participants with bone metastasis only must provide an archival tumor tissue specimen

=> Has prostate cancer progression within 6 months prior to screening, as determined by the investigator, by means of one of the following:
> PSA progression as defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each assessment where the PSA value at screening should be ≥2 ng/mL;
> radiographic disease progression in soft tissue based on Response Evaluation Criteria In Solid Tumors Version 1.1 criteria with or without PSA progression; > radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression

=> Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM).
Treatment with luteinizing hormone-releasing hormone agonists or antagonists for all Cohorts must have been initiated ≥4 weeks prior to first dose of study therapy and must be continued throughout the study

> For Cohort A: Has received docetaxel for mCRPC.
Prior treatment with 1 other chemotherapy for mCRPC is allowed.
Up to 2 second-generation hormonal manipulations (e.g., abiraterone acetate and/or enzalutamide) are allowed. Prior docetaxel for metastatic hormone-sensitive prostate cancer is allowed if ≥4 weeks have elapsed from the last dose of docetaxel prior to day 1 of Cycle 1

> For Cohort B: Has received prior treatment with either abiraterone acetate or enzalutamide (but not both) in the prechemotherapy mCRPC state. Participants in Cohort B must have received at least 4 weeks of either abiraterone or enzalutamide treatment (but not both) who failed treatment or became intolerant of the drug

> For Cohort C: Has received prior treatment with abiraterone acetate in the pre-chemotherapy mCRPC state without prior enzalutamide. Participants in Cohort C must have received at least 4 weeks of abiraterone treatment who failed treatment or become intolerant of the drug. Participants who received abiraterone acetate in the hormone-sensitive state will not be eligible

> For Cohort D: Has not received chemotherapy for mCRPC and has either not had prior second generation hormonal manipulation for mCRPC OR has previously been treated with enzalutamide for mCRPC and failed treatment or has become intolerant of the drug.
Prior docetaxel for metastatic hormone-sensitive prostate cancer is allowed if ≥4 weeks have elapsed from the last dose of docetaxel.
Prior treatment with abiraterone acetate in the hormone-sensitive metastatic setting is allowed as long as there was no progression on this agent and abiraterone acetate was not discontinued due to adverse events (AEs)

> For Cohorts E, F, and H: Has received docetaxel for mCRPC. Prior treatment with 1 other chemotherapy for mCRPC is allowed. Up to 2 second-generation hormonal manipulations (eg, abiraterone acetate, enzalutamide, apalutamide, darolutamide or other next-generation hormonal agents [NHA]) are allowed.
Participants who received prior ketoconazole for metastatic disease may be enrolled.
If docetaxel chemotherapy is used more than once (eg, once for metastatic hormone-sensitive and once for mCRPC), it will be considered as 1 therapy.
Prior docetaxel for metastatic hormone-sensitive prostate cancer is allowed if ≥4 weeks have elapsed from the last dose of docetaxel prior to Day 1 of Cycle 1

> For Cohorts G and I: Has received docetaxel for mCRPC. Prior treatment with 1 other chemotherapy for mCRPC is allowed. Up to 2 second-generation hormonal manipulations (eg, abiraterone acetate, enzalutamide, apalutamide, darolutamide, or other NHA) are allowed.
Participants who received prior ketoconazole for metastatic disease may be enrolled. I
If docetaxel chemotherapy is used more than once (eg, once for metastatic hormone-sensitive and once for mCRPC), it will be considered as 1 therapy.
Prior docetaxel for metastatic hormone-sensitive prostate cancer is allowed
if ≥4 weeks have elapsed from the last dose of docetaxel prior to Day 1 of Cycle 1

> For Cohorts H and I: Has aggressive disease progression manifested by progression within 6 months of starting next-generation hormonal agents (NHA) for metastatic hormone-sensitive prostate cancer (mHSPC) or mCRPC and progression within <6 cycles of docetaxel treatment for mCRPC (docetaxel for mHSPC is allowed in addition to docetaxel for mCRPC)


Exclusion Criteria:

=> Has had prior chemotherapy, targeted small molecule therapy abiraterone treatment, enzalutamide treatment, or radiation therapy within 2 weeks prior to first dose of study therapy or who has not recovered (ie, Grade ≤1 or at baseline) from AEs due to a previously administered agent

=> Has a "superscan" bone scan defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan such that the presence of additional metastases in the future could not be evaluated

For Cohort B: Has received prior treatment with docetaxel or another chemotherapy agent for metastatic prostate cancer


For Cohort C: Has received prior chemotherapy for mCRPC.
Prior docetaxel for metastatic hormone-sensitive prostate cancer is allowed
if ≥4 weeks elapsed from last dose of docetaxel.
Participants who received abiraterone acetate in the hormone-sensitive state will not be eligible


Poland
MSD Polska Sp. Z o.o. Recruiting
Warsaw, Poland
Contact: Thomas Johansson 48 22ý478 43 24


https://clinicaltrials.gov/ct2/show/NCT02861573
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AMPLITUDE - Niraparib +ABI vs ABI w mCSPC z mutacją HRR

Nieprzeczytany postautor: zosia bluszcz » 03 gru 2021, 15:23

BADANIE KLINICZNE AMPLITUDE W DALSZYM CIĄGU PROWADZI REKRUTACJĘ


AMPLITUDE:
A Phase 3 Randomised Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) NCT04497844



Criteria

Inclusion criteria:

=> Pathological diagnosis of prostate adenocarcinoma

=> Must have appropriate deleterious homologous recombination repair (HRR) gene alteration

=> Androgen deprivation therapy (either medical or surgical castration) must have been started >=14 days prior to randomization and participants be willing to continue androgen deprivation therapy (ADT) through the treatment phase

=> Other allowed prior therapy for metastatic castration-sensitive prostate cancer (mCSPC):
(a) maximum of 1 course of radiation and 1 surgical intervention for symptomatic control of prostate cancer (example, uncontrolled pain, impending spinal cord compression or obstructive symptoms).
Participants with radiation or surgical interventions to all known sites of metastatic disease will be excluded from trial participation.
Radiation must be completed prior to randomization
(b) Up to a maximum of 6 months of ADT prior to randomization;
(c) Up to a maximum of 45 days of abiraterone acetate + prednisone (AA-P) prior to randomization
(d) Up to a maximum of 2 weeks of ketoconazole for prostate cancer prior to randomization



Exclusion criteria:

=> Prior treatment with a poly (adenosine diphosphate-ribose) polymerase (inhibitor) (PARP) inhibitor


Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi Recruiting
Lodz, Poland, 93-509

Medisport Recruiting
Lublin, Poland, 20-223


https://clinicaltrials.gov/ct2/show/NCT04497844
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TAVT-45(granulat ABI) vs ABI w mCSPC & mCRPC

Nieprzeczytany postautor: zosia bluszcz » 03 gru 2021, 16:07

REKRUTACJA ZAKOŃCZONA

Phase 3 Study Investigating the Efficacy and Safety of TAVT-45 (Abiraterone Acetate) Granules for Oral Suspension (Novel Abiraterone Acetate Formulation) Relative to a Reference Abiraterone Acetate Formulation in Patients With mCSPC & mCRPC
NCT04887506


https://clinicaltrials.gov/ct2/show/NCT04887506
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PSMAddition 177Lu-PSMA-617+SoC vs SoC w mHSPC

Nieprzeczytany postautor: zosia bluszcz » 03 gru 2021, 23:15

REKRUTACJA ZAKOŃCZONA


PSMAddition:
An Open-label, Randomised Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care, Versus Standard of Care Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) NCT04720157



https://clinicaltrials.gov/ct2/show/NCT04720157
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PSMAfore - 177Lu-PSMA-617 vs zmiana ARDT w mCRPC przed DX

Nieprzeczytany postautor: zosia bluszcz » 03 gru 2021, 23:27

REKRUTACJA ZAKOŃCZONA


PSMAfore: A Phase III, Open-label, Multi-Center, Randomised Study Comparing 177Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in the Treatment of Taxane Naïve Men With Progressive Metastatic Castrate Resistant Prostate Cancer
NCT04689828


https://clinicaltrials.gov/ct2/show/NCT04689828
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Xofigo (Radium-223) vs standard NAH (ABI/ENZ) w mCRPC po 1.

Nieprzeczytany postautor: zosia bluszcz » 04 gru 2021, 03:47

BADANIE KLINICZNE XOFIGO vs NAH W DALSZYM CIĄGU PROWADZI REKRUTACJĘ



A Phase 4, Randomized, Open-label, Multicenter Efficacy and Safety Study of Standard Dose of Radium-223 Dichloride vs. Standard Doses of Novel Anti-hormonal Therapy (NAH) in Patients With Bone Dominant Metastatic Castration Resistant Prostate Cancer (mCRPC) Progressing on/After One Line of NAH (NCT04597125)


Brief Summary:
Researchers in this study want to compare how well drug radium-223 dichloride (Xofigo) and new (novel) anti-hormonal (NAH) therapy work in participants with prostate gland cancer which has spread to the bone and progressed on or after one line of NAH therapy.
Meanwhile researchers want to compare the safety of radium-223 dichloride and NAH therapy.
Radium-223 dichloride is known as a radioactive drug that is taken up by bones after it is injected into the body. It works by giving off a type of radioactivity that travels a very short distance and kills the tumor cells that have spread to the bone without major effects to the healthy cells. It has been approved in many countries for the treatment of patients with prostate cancer which has spread to the bone.

The NAH drugs used in this study will be either abiraterone acetate (Zytiga) (plus prednisone/prednisolone) or enzalutamide (Xtandi).
Both of them are standard approved medications which are used in the treatment of advanced prostate cancer.

Participants in this study will receive either Radium-223 dichloride or a NAH therapy.
=> Radium-223 dichloride will be given as an infusion into one of the veins on Day 1 of each 4-week cycle for a total of up to 6 cycles.
=> Oral NAH therapy will be given per the standard approved dose once daily until the disease has progressed.

Participants will visit the hospital or clinic every 2 weeks for the first 6 cycles, and only on the first day of each cycle from cycle 7 and onwards.
Observation for each participant will last for about 2 years in total.
Blood and urine samples will be collected from the participants and participants will be asked to complete questionnaires about the well-being and the pain.


Criteria

Inclusion Criteria:

=> Participants who have histologically confirmed adenocarcinoma of the prostate.
=> Participants with metastatic castrate resistant prostate cancer (mCRPC) progressing on/after one line of novel anti-hormonal therapy (NAH) (after being treated for at least 3 months) for metastatic prostate cancer (mHSPC and mCRPC).

=> One prior taxane treatment regimen (at least 2 cycles) for metastatic prostate cancer (mHSPC and mCRPC) or refusal or ineligibility of such a regimen.

=> Prostate cancer progression documented by PSA according to the Prostate Cancer Working Group 3 (PCWG3) criteria or radiological progression according to RECIST, version 1.1.

=> At least 2 bone metastases on bone scan within 4 weeks prior to randomization with no current or history of lung, liver, other visceral, and / or brain metastasis.

=> Symptomatic prostate cancer.
A worst pain score (WPS) of at least 1 on the Brief Pain Inventory-Short Form (BPI-SF) Question #3 (worst pain in last 24 hours). This is to be assessed once during the Screening period.

=> Maintenance of medical castration or surgical castration with testosterone less than 50 ng/dL (1.7 nmol/L).
If the participant is being treated with luteinizing hormone releasing hormone (LHRH) agonists or antagonists (participant who has not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to randomization and must be continued throughout the study.

=> Participants must be on a BHA treatment, such as bisphosphonates or denosumab treatment unless such treatment is contraindicated or not recommended per investigator's judgement and inclusion is agreed to by the medical monitor.

=> Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.


Exclusion Criteria:

=> Active infection or other medical condition that would make prednisone / prednisolone (corticosteroid) use contraindicated.

=> Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone / prednisolone twice daily.

=> Pathological finding consistent with tumors with neuroendocrine features or small cell carcinoma of the prostate.

=> History of osteoporotic fracture

=> History of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations.

=> History of or known brain metastasis.

=> Malignant lymphadenopathy exceeding 3 cm in short-axis diameter.


=> Clinically significant heart disease


=> Prior systemic radiotherapy with strontium-89, samarium-153, rhenium-186, rhenium-188, or radium-223.

=> Prior hemibody external radiotherapy is excluded. Participants who received other types of prior external radiotherapy are allowed provided that the bone marrow function is assessed and meets the protocol requirements for Hb, ANC, and platelet count.

Blood transfusion or erythropoietin stimulating agents 4 weeks prior to Screening and during the whole Screening period before randomization.

=> Excessive intake of biotin above the recommended daily dose of 30 μg. Biotin is found in multivitamins, including prenatal multivitamins, biotin supplements, and dietary supplements for hair, skin, and nail growth at levels that may interfere with laboratory tests.

=> Prior administration of an investigational therapeutic for CRPC.



Poland

Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie Recruiting
Koszalin, Poland, 75-851

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Not yet recruiting
Krakow, Poland, 31-115

Szpital Grochowski im. dr.med. Rafala Masztaka Not yet recruiting
Warszawa, Poland, 04-073
Uniwersytecki Szpital Kliniczny UM we Wroclawiu Recruiting
Wroclaw, Poland, 50-556


https://clinicaltrials.gov/ct2/show/NCT ... w=2&rank=8
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Olaparib + Pembrolizumab - pacjenci z mut. HRR

Nieprzeczytany postautor: zosia bluszcz » 04 lut 2022, 08:10

REKRUTACJA ZAKOŃCZONA


A Phase 2 Study of Olaparib in Combination With Pembrolizumab in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer - NCT04123366

https://clinicaltrials.gov/ct2/show/NCT04123366





_________________________________

Wszyscy pacjenci z przerzutowym rakiem prostaty w momencie diagnozy oraz pacjenci z progresją podczas leczenia antyandrogenami II generacji (abirateron/enzalutamid) powinni być testowani na obecność mutacji HRR.
NCCN zaleca testowanie wszystkich pacjentów z mCRPC.




HRRm Testing – Metastatic Prostate Cancer – LYNPARZA® (olaparib)

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer recommend tumor testing for HRRm for any patient with mCRPC.


WHO should be tested for HRRm?

Test all patients with advanced prostate cancer at metastatic diagnosis or upon progression with enzalutamide or abiraterone.


Test for HRR gene mutations

Using FDA-approved companion diagnostics for LYNPARZA:
- FoundationOne® CDx
- FoundationOne® Liquid CDx
- Myriad BRACAnalysis CDx®



HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer
For the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

ADVERSE REACTIONS — HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer
Most common adverse reactions (Grades 1-4) in ≥10% of patients in clinical trials of LYNPARZA for PROfound were:
anemia (46%), fatigue (including asthenia) (41%), nausea (41%), decreased appetite (30%), diarrhea (21%), vomiting (18%), thrombocytopenia (12%), cough (11%), and dyspnea (10%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients in clinical trials of LYNPARZA for PROfound were:
decrease in hemoglobin (98%), decrease in lymphocytes (62%), decrease in leukocytes (53%), and decrease in absolute neutrophil count (34%).


https://www.lynparzahcp.com/metastatic- ... sting.html
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CaP - badania kliniczne prowadzone w PL - stan na 04.02.2022

Nieprzeczytany postautor: zosia bluszcz » 04 lut 2022, 08:15

Wykaz badań klinicznych dotyczących CaP zarejestrowanych na amerykańskiej stronie clinicaltrilas.gov aktualnie prowadzących rekrutuję w Polsce (stan na 04.02.2022).

Informacje dot. kryteriów kwalifikacyjnych poszczególnych badań znajdują się w postach powyżej (jedno badanie = jeden post).

Informacje są wprawdzie w języku angielskim, ale można je w ułamku sekundy przetłumaczyć na język polski używając Google Translate https://translate.google.com


CaP_Badania Kliniczne w PL_04.02.2022.pdf
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Fuzuloparib+ABI vs Placebo +ABI jako 1. linia terapii w mCRP

Nieprzeczytany postautor: zosia bluszcz » 04 lut 2022, 10:06

BADANIE KLINICZNE FUZULOPARIB + ZYTIGA vs ZYTIGA PROWADZI REKRUTACJĘ



A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Versus Placebo Combined With AA-P as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer - NCT04691804

Criteria

Inclusion Criteria
=> Able and willing to provide a written informed consent
=> A score of 0 to 1 for ECOG performance status
(...)
=> Prostate adenocarcinoma confirmed
=> Disease progression of metastatic prostate cancer while the subject was on androgen deprivation therapy.
=> The functional level of the organs must meet the requirements
=> Blood and tumor tissue samples are provided during screening to determine the DRD status


Exclusion Criteria
=> Prior treatment with any PARP inhibitor
=> Have received any systemic anti-tumor treatment during the mCRPC stage or non-metastatic CRPC stage

=> Have used any CYP3A4 inducers or inhibitors within 14 days prior to the first dose
=> Plan to receive any other anti-tumor treatment
=> Presence of radiologically confirmed tumor lesions in the brain
=> Contraindications to the use of Prednisone
=> History of uncontrolled pituitary or adrenal dysfunction
=> Uncontrolled hypertension
=> Presence of active heart diseases
=> Human immunodeficiency virus-positive
=> Presence of dysphagia, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption
=> Active HBV or HCV infection
=> Presence of concomitant diseases


Poland

Szpitale Pomorskie Sp.zo.o Recruiting
Gdynia, Poland
Principal Investigator: Iwona Danielewicz

Regionalny Szpital Specjalistyczny im.dr. Wladyslawa Bieganskiego Recruiting
Grudziadz, Poland
Principal Investigator: Urszula Sadowska

Clinical Research Center Sp. z o.o. Recruiting
Kobylniki, Poland
Principal Investigator: Ilona Bar Letkiewicz

Szpital Wojewdzki w Koszalinie im. Mikoaja Kopernika Recruiting
Koszalin, Poland
Principal Investigator: Mariusz Kwiatkowski '

University Hospital Recruiting
Krakow, Poland
Principal Investigator: Piotr Wysocki

Szpital Kliniczny Nr Pozna? Recruiting
Poznan, Poland
Principal Investigator: Piotr Tomczak

Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie w Warszawie Not yet recruiting
Warszawa, Poland
Principal Investigator: Pawel Wiechno

Dolnoslaskie Centrum Onkologii - Lower Silesian Oncology Center Not yet recruiting
Wroclaw, Poland
Principal Investigator: Krzysztof Tupikowski



https://clinicaltrials.gov/ct2/show/NCT ... w=2&rank=8
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CYCLONE 3 - Abemaciclib +ABI vs ABI w mHSCP wysokiego ryzyka

Nieprzeczytany postautor: zosia bluszcz » 16 wrz 2022, 14:19

Badanie kliniczne dla pacjentów z przerzutowym, hormonozależnym rakiem prostaty wysokiego ryzyka.
Wszyscy uczestnicy badania dostają Abirateron z prednizonem
plus
albo Abemacyclib, silny inhibitorem kinazy CDK4/6, (stosowany w leczeniu raka piersi),
albo placebo.

Jednym z warunków kwalifikacji brak systemowego leczenia przed randomizacją, z wyjątkiem
- maksimum 3 miesięcznej HT (bez progresji PSA/progresji wykazanej w badaniach obrazowych)
lub
- 6 cykli CHT DX w połączeniu z HT (bez progresji PSA/progresji wykazanej w badaniach obrazowych).

Na dziś nabór do tego badania klinicznego CYKLON 3 jest prowadzony jest jedynie w Lublinie oraz w Piotrkowie Trybunalskim.



A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer) (CYCLONE 3) NCT05288166


Inclusion Criteria:

=> Adenocarcinoma of the prostate.

=> High-risk metastatic disease defined as:
- Greater than or equal to (≥)4 bone metastases and/or
- ≥1 visceral metastases


=> Androgen deprivation therapy (either medical with a luteinizing hormone-releasing hormone [LHRH] analogue or surgical castration) must have been started prior to randomization and continued throughout the study.

=> Adequate organ function

=> Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1


Exclusion Criteria:

=> Prior treatment with abemaciclib or any other cyclin dependent kinase 4 and 6 (CDK4 & 6) inhibitor

=> Development of metastatic prostate cancer in the context of castrate levels of testosterone (≤50 ng/dL)

=> Received any prior systemic therapy for metastatic prostate cancer (including investigational agents), the following exceptions are permitted:

- Up to 3 months of androgen deprivation therapy (ADT) (when given without docetaxel) AND absence of radiographic or prostate specific antigen (PSA) progression prior to randomization
- Up to 6 cycles of docetaxel with ADT AND absence of radiographic or PSA progression prior to randomization


=> Clinically significant cardiovascular disease as evidenced by myocardial infarction, arterial thrombotic events, or severe/unstable angina in the past 6 months, or New York Heart Association Class II to IV heart failure

=> History of syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin, or sudden cardiac arrest. Chronic and hemodynamically stable atrial arrhythmia well-controlled on medical therapy is permitted

=> Uncontrolled hypertension

=> Clinically active or chronic liver disease, moderate/severe hepatic impairment

=> Known untreated central nervous system (CNS) metastasis.
Patients with a history of treated brain metastases are eligible provided that disease is stable following treatment for at least 8 weeks prior to randomization and no requirement for corticosteroid use


Poland

Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii Not yet recruiting
Wroclaw, Dolnośląskie, Poland, 53-413
Contact 48713689677
Principal Investigator: Lukasz Dolowy


Clinical Best Solutions - Recruiting
Lublin, Lubelskie, Poland, 20-078
Principal Investigator: Pawel Plaza



Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie Not yet recruiting
Warszawa, Mazowieckie, Poland, 02-781
Principal Investigator: Pawel Wiechno


Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego Not yet recruiting
Opole, Opolskie, Poland, 45-061
Contact 48774416088
Principal Investigator: Barbara Radecka


Szpitale Pomorskie Sp. z o. o. Not yet recruiting
Gdynia, Pomorskie, Poland, 81-519
Contact 48587260417
Principal Investigator: Dorota Filarska


Wielkopolskie Centrum Onkologii Not yet recruiting
Poznan, Wielkopolskie, Poland, 61-866
Contact 486081222290
Principal Investigator: Jolanta Korczak


Salve Medica Not yet recruiting
Lodz, Łódzkie, Poland, 91-211
Principal Investigator: MONIKA KUKULSKA


Provita Profamilia - Recruiting
Piotrkow Trybunalski, Łódzkie, Poland, 97-300
Contact 4860185303
Principal Investigator: Jacek Fijuth


https://clinicaltrials.gov/ct2/show/NCT ... w=2&rank=8
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BADANIA KLINICZNE PROWADZONE W POLSCE - stan na 18.09.2022

Nieprzeczytany postautor: zosia bluszcz » 18 wrz 2022, 10:18

BADANIA KLINICZNE PROWADZONE W POLSCE ZAREJESTROWANE NA AMERYKANSKIEJ STRONIE clinicaltrials.gov
(stan na 18.09.2022)


LISTA BADAŃ KLINICZNYCH PROWADZONYCH W POLSCE DLA PACJENTÓW z CRPC (rakiem prostaty opornym na kastrację)


ClinicalTrials_CRPC_18.09.2022_PL.pdf




LISTA BADAŃ KLINICZNYCH PROWADZONYCH W POLSCE DLA PACJENTÓW z HSCP (rakiem prostaty wrażliwym na kastrację)


ClinicalTrials_HSCP_18.09.2022_PL.pdf
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PROTEUS Erleada vs placebo - HR PCa u kandydatów do RP

Nieprzeczytany postautor: zosia bluszcz » 13 paź 2022, 09:34

PROTEUS
A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy NCT03767244



Detailed Description:

High-risk prostate cancer accounts for approximately 15 percent (%) of newly diagnosed prostate cancers. A systemic therapy that eradicates micrometastatic disease is needed to improve survival in high-risk participants undergoing RP with pLND.
It is hypothesized that androgen blockade prior to and after RP with pLND may improve outcomes for participants at the highest risk for recurrence. This study is designed to evaluate if androgen blockade administered prior to and after RP with pLND will increase the rate of pathological complete response (pCR) and lead to better overall outcomes.

ERLEADA (apalutamide, also known as JNJ-56021927 and ARN-509) is an orally available, non-steroidal small molecule, which acts as a potent and selective antagonist of the androgen receptor (AR), currently being developed for the treatment of prostate cancer.

The study includes screening phase (approximately up to 35 days before randomization), treatment phase (the planned Treatment Phase will include a total of 12 treatment cycles of apalutamide or placebo; 6 cycles prior to RP with pLND (Cycle 1 through Cycle 6) and 6 cycles after RP with pLND (Cycle 7 through Cycle 12).

Cycle 1 Day 1 will start within 3 days after randomization) and follow-up phase.

The end of study (study completion) is defined as last participant assessment at study site with approximate study duration of 8 years. Participants will undergo efficacy, pharmacokinetics and biomarker evaluations. The safety will be monitored throughout the study. An open-label sub-study comparing apalutamide plus ADT before and after RP with pLND with standard of care treatment will be initiated at selected sites upon notification by the sponsor.



Inclusion Criteria:

=> Histologically confirmed adenocarcinoma of the prostate

=> High-risk disease defined by a total Gleason Sum Score greater than equal to (>=) 4+3 (=Grade Groups [GG] 3-5)
and >=1 of the following 4 criteria:
a) Any combination of Gleason Score 4+3 (= 3) and Gleason Score 8 (4+4 or 5+3) in >= 6 systematic cores (with >=1 core Gleason Score 8 [4+4 or 5+3] included);
b) Any combination of Gleason Score 4+3 (=GG 3) and Gleason Score 8 (4+4 or 5+3) in >=3 systematic cores and Prostate-specific antigen (PSA) >=20 ng/mL (with >= 1 core Gleason Score 8 [4+4 or 5+3] included);
c) Gleason Score >=9 (=GG 5) in at least 1 systematic or targeted core;
d) At least 2 systematic or targeted cores with continuous Gleason Score >=8 (=GG 4), each with > 80 percent (%) involvement


=> Candidate for radical prostatectomy with pelvic lymph node dissection as per the investigator

=> Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1

=> Contraceptive use by male participants (and female partners of male participants enrolled in the study who are of childbearing potential or are pregnant) should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies

=> Able to receive androgen deprivation therapy (ADT) for at least 13 months



Exclusion Criteria:

=> Distant metastasis based on conventional imaging (clinical stage M1).
- Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion.
- Diagnosis of distant metastasis (clinical M stage; M0 versus M1a, M1b, M1c) and pelvic nodal disease (clinical N stage; N1 versus N0) will be assessed by central radiological review.
- Participants are considered eligible only if the central radiological review confirms clinical stage M0

(a) Prior treatment with androgen receptor antagonists;
(b) Treatment with gonadotropin-releasing hormone analog (GnRHa) prior to informed consent form (ICF) signature

=> History of prior systemic or local therapy for prostate cancer, including pelvic radiation for prostate cancer

=> Use of any investigational agent less than or equals to (<=)4 weeks prior to randomization or any therapeutic procedure for prostate cancer at any time

=> Major surgery <=4 weeks prior to randomization

=> Any of the following within 12 months prior to first dose of study drug:
severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (example, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias or New York Heart Association Class II to IV heart disease; uncomplicated deep vein thrombosis is not considered exclusionary



Poland

Samodzielny Publiczny Wielospecjalistyczny Zakład Opieki Zdrowotnej MSWiA w Bydgoszczy Recruiting
Bydgoszcz, Poland, 85-015

Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza Recruiting
Bydgoszcz, Poland, 85-094

Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie Recruiting
Koszalin, Poland, 75-581

Pratia MCM Krakow Recruiting
Krakow, Poland, 30-510

City Clinic Sp. z o.o. Recruiting
Warszawa, Poland, 02-473

Dolnoslaskie Centrum Onkologii, Oddzial Chirurgii Onkologicznej II - Urologia Recruiting
Wrocław, Poland, 53-413


https://clinicaltrials.gov/ct2/show/NCT ... =2&rank=13
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CaP BADANIA KLINICZNE PROWADZONE W PL stan na 24.06.2024

Nieprzeczytany postautor: zosia bluszcz » 24 cze 2024, 00:00

CaP_badania kliniczne_PL_24.06.2024.pdf
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