Trial Search Results
Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer
Primary objective was to demonstrate overall survival improvement with aflibercept compared to placebo in patients receiving docetaxel / prednisone for metastatic androgen-independent prostate cancer (MAIPC).
The secondary objectives were:
- To assess the efficacy of aflibercept compared to placebo on other parameters such prostate-specific antigen (PSA) level, cancer related pain, progression free survival (PFS), tumor-based and skeletal events and health-related quality of life (HRQL);
- To assess the overall safety in both treatment arms;
- To determine the pharmacokinetics of intravenous (IV) aflibercept in this population;
- to determine immunogenicity of IV aflibercept.
Stanford is currently not accepting patients for this trial.
Collaborator: Regeneron Pharmaceuticals
- Drug: Aflibercept
- Drug: Placebo (for aflibercept)
- Drug: Docetaxel
- Drug: Prednisone or Prednisolone
- Histologically- or cytologically-confirmed prostate adenocarcinoma;
- Metastatic disease;
- Progressive disease while receiving hormonal therapy or after surgical castration;
- Effective castration.
- 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
- 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.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study