Phase 3
N=1,224
Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer
Prostatic Neoplasms · Neoplasm Metastasis
Bottom Line
View on ClinicalTrials.gov: NCT00519285 ↗Enrolled (actual)
1,224
Serious AEs
42.6%
Results posted
Oct 2013
Primary outcome: Primary: Overall Survival Time — 21.22; 22.14 months — p=0.3802
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aflibercept (Drug); Placebo (for aflibercept) (Drug); Docetaxel (Drug); Prednisone or Prednisolone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Sanofi
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival Time |
21.22; 22.14 | 0.3802 |
| SECONDARY Prostate Specific Antigen Response Rate |
63.5; 68.6 | — |
| SECONDARY Time to Skeletal Related Events |
14.98; 15.31 | — |
| SECONDARY Progression Free Survival Time |
6.24; 6.90 | — |
| SECONDARY Tumor Response Rate in Participants With Measurable Disease |
28.1; 38.7 | — |
| SECONDARY Prostate Specific Antigen Progression-free Survival Time |
8.11; 8.25 | — |
| SECONDARY Pain Progression-free Survival Time |
9.72; 9.20 | — |
| SECONDARY Pain Response Rate |
46.3; 35.8 | — |
| SECONDARY Change From Baseline in Functional Assessment of Cancer Therapy-Prostate Total Score as a Measure of Health Related Quality of Life |
5.08; 1.30; 6.22; -0.03; 5.50; -1.00 | — |
| SECONDARY Number of Participants With Adverse Events as a Measure of Safety |
585; 607; 290; 470; 184; 331 | — |
| SECONDARY Number of Participants With Positive Anti-aflibercept Antibody Levels as a Measure of Immunogenicity of Aflibercept |
0; 2; 4; 9; 0; 2 | — |
Summary
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.
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.
Data sourced from ClinicalTrials.gov (NCT00519285). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.