Advanced Prostate Carcinoma MedDRA version: 7.1 Level: PT Classification code 10036909
Conditions
Interventions
Product Name: YONDELIS (trabectedin)
Product Code: ET-743, R279741, RWJ-680581
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: trabectedin
CAS Number: 114899-77-3
Current Sp
RWJ680581
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: trabectedin
CAS Number: 114899-77-3
Current Sponsor code: ET-743
Other descriptive name: Ecteinascidin 743
Concentr
Sponsors
Pharma Mar SA, Sociedad Unipersonal
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: In Cohort A: . Signed informed consent · Histologically confirmed adenocarcinoma of the prostate · Radiographically documented metastatic disease · Surgical or chemical castration · PSA > 5 ng/ml · Androgen-independent disease, as defined by detectable, rising PSA in two consecutive measurements at least one week apart, with a minimum increment of at least 5 ng/ml above the nadir · No more than one previous chemotherapy regimen · ECOG/WHO performance status of 0, 1 or 2 · Adequate bone marrow reserve(s): - Neutrophil count > 1,500/ ml - Platelet count > 100,000/ ml · Adequate hepatic function: - Serum bilirubin 2.5 g/dl · Adequate renal function, with serum creatinine 5 ng/ml · Androgen-independent disease, as defined by detectable, rising PSA in two consecutive measurements at least one week apart, with a minimum increment of at least 5 ng/ml above the nadir · Previous treatment with one docetaxel based chemotherapy regimen · ECOG/WHO performance status of 0, 1 or 2 · Adequate bone marrow reserve(s): - Neutrophil count > 1,500/ µl - Platelet count > 100,000/ µl - Adequate hepatic function: - Serum bilirubin 2.5 g/dl · Adequate renal function, with serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: In Cohort A: . Small cell carcinoma of the prostate · Current treatment with chemotherapy or radiation therapy · Treatment with extensive external beam radiation therapy or radionuclide therapy within six weeks of study entry. Palliative radiation involving less than 20% of bone marrow reserves must have been completed within four weeks of entry · Treatment with chemotherapy within 4 weeks of study entry · Patient not employing adequate contraception · Other serious illness or medical conditions, specifically: - Uncontrolled congestive heart failure or HISTORY of myocardial infection or active angina pectoris within 6 months preceding registrations - Active infectious process - Chronic active liver disease, including chronic hepatitis B, chronic hepatitis C, or cirrhosis · Current anticancer treatment with any other non-FDA-approved investigational drug · ECOG performance status of 3 or worse In Cohort B: · Small cell carcinoma of the prostate · Treatment with chemotherapy or radiation therapy was terminated at least 4 weeks before study entry · Treatment with extensive external beam radiation therapy or radionuclide therapy within six weeks of study entry. Palliative radiation involving less than 20% of bone marrow reserves must have been completed at least four weeks before study entry · Treatment with chemotherapy terminated at least 4 weeks before study entry · Patient not employing adequate contraception · Other serious illness or medical conditions, specifically: -Uncontrolled congestive heart failure or HISTORY of myocardial infection or active angina pectoris within 6 months preceding registrations - Active infectious process - Chronic active liver disease, including chronic hepatitis B, chronic hepatitis C, or cirrhosis · Current anticancer treatment with any other non-FDA-approved investigational drug · ECOG performance status of 3 or worse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): PSA response, duration of response, and time to progression;Main Objective: To determine the safety and efficacy of Yondelis®(trabectedin) treatment in metastatic prostate carcinoma In Cohort A: To measure PSA response in men with AIPC treated with Yondelis® In Cohort B: To measure PSA response, duration of response, and time to progression in an additional cohort of 16 prostate cancer subjects previously treated with docetaxel that will be treated with YONDELIS® administered by a 24-h infusion every 3 weeks ;Secondary Objective: In Cohort A: To assess the safety of administration of Yondelis® as a weekly, three-hour infusion in this population of patients. To measure , duration of response and time to progression in men with AIPC treated with Yondelis®. In Cohort B: To assess the safety of administration of Yondelis® as a 24-hours infusion every three weeks in these subjects | — |
Countries
Spain
Outcome results
None listed