DRKS00003881
Completed
Phase 3
A Multicenter, Randomized, Double Blind Study Comparing the Efficacy and Safety of Aflibercept Versus Placebo Administered Every 3 Weeks in Patients Treated With Docetaxel/ Prednisone for Metastatic Androgen-independent Prostate Cancer - VENICE
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Prostatic NeoplasmsNeoplasm Metastasis
- Sponsor
- Sanofi
- Enrollment
- 1224
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically\- or cytologically\-confirmed prostate adenocarcinoma;
- •\- Metastatic disease;
- •\- Progressive disease while receiving hormonal therapy or after surgical castration;
- •\- Effective castration.
Exclusion Criteria
- •\- Prior cytotoxic chemotherapy for prostate cancer, except estramustine and except
- •adjuvant/neoadjuvant treatment completed \>3 years ago;
- •\- Prior treatment with Vascular Endothelial Growth Factor (VEGF) inhibitors or VEGF
- •receptor inhibitors;
- •\- Eastern Cooperative Oncology Group (ECOG) performance status \>2\.
- •The above information is not intended to contain all considerations relevant to a
- •patient's potential participation in a clinical trial.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
Study Evaluating Once Monthly Darbepoetin Alfa Dosing for the Correction of Anemia in Non-dialysis Patients With Chronic Kidney DiseaseEUCTR2006-003173-27-PLAmgen Ltd334
Active, not recruiting
Not Applicable
A Multicenter, Randomized, Double-blind Study Comparing De Novo OnceMonthly and Once Every 2 Week Darbepoetin alfa Dosing for the Correction ofAnemia in Subjects With Chronic Kidney Disease Not Receiving DialysisEUCTR2006-003173-27-GRAmgen Ltd540
Active, not recruiting
Phase 1
A Multicenter, Randomized, Double-blind Study Comparing De Novo Once Monthly and Once Every 2 Week Darbepoetin alfa Dosing for the Correction of Anemia in Subjects With Chronic Kidney Disease Not Receiving DialysisAnemia in subjects with chronic kidney disease not receiving dialysisMedDRA version: 9.1 Level: LLT Classification code 10002272 Term: AnemiaMedDRA version: 9.1 Level: LLT Classification code 10064848 Term: Chronic kidney diseaseEUCTR2006-003173-27-GBAmgen Ltd540
Active, not recruiting
Not Applicable
A Multicenter, Randomized, Double-blind Study Comparing De Novo OnceMonthly and Once Every 2 Week Darbepoetin alfa Dosing for the Correction ofAnemia in Subjects With Chronic Kidney Disease Not Receiving DialysisAnemia in subjects with chronic kidney disease not receiving dialysisMedDRA version: 9.1Level: LLTClassification code 10002272Term: AnemiaMedDRA version: 9.1Level: LLTClassification code 10064848Term: Chronic kidney diseaseEUCTR2006-003173-27-SIAmgen Ltd540
Active, not recruiting
Not Applicable
Study Evaluating Once Monthly Darbepoetin Alfa Dosing for the Correction of Anemia in Non-dialysis Patients With Chronic Kidney DiseaseAnemia in subjects with chronic kidney disease not receiving dialysisMedDRA version: 14.1Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disordersMedDRA version: 14.1Level: LLTClassification code 10002272Term: AnemiaSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]EUCTR2006-003173-27-DEAmgen Ltd334