Phase 2
N=218
Study of AVE0005 (VEGF Trap) in Patients With Chemoresistant Advanced Ovarian Cancer
Neoplasms · Cancer of the Ovary
Bottom Line
View on ClinicalTrials.gov: NCT00327171 ↗Enrolled (actual)
218
Serious AEs
49.8%
Results posted
Oct 2012
Primary outcome: Primary: Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by an Independent Review Committee (IRC) - Simon's Cohort — 0; 3 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Sanofi
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by an Independent Review Committee (IRC) - Simon's Cohort |
0; 3 | — |
| PRIMARY Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by the IRC - Efficacy Evaluable Population |
1; 5 | — |
| SECONDARY Number of Participants With a Clinical Benefit Response (CBR) as Per RECIST Based on the Analysis by the IRC |
12; 7 | — |
| SECONDARY Duration of Response (DR) Based on the Analysis by an Independent Review Committee (IRC) |
164; 149.8 | — |
| SECONDARY Tumor Marker Response Rate (TMRR) Based on the Gynecologic Cancer Intergroup (GCIG) Definition |
11.5; 11.6 | — |
| SECONDARY Time to Tumor Progression (TTP) as Per RECIST Based on the Analysis by the IRC |
13.1; 12.7 | 0.5043 |
| SECONDARY Time to Tumor Marker (CA-125) Progression (TTMP) |
NA; NA | — |
| SECONDARY Number of Participants With Disease Progression Events for Progression-free Survival (PFS) Analysis by the IRC. |
66; 66; 16; 23; 18; 14 | — |
| SECONDARY Progression-free Survival (PFS) Time Based on Analysis by the IRC |
13.0; 13.3 | 0.5592 |
| SECONDARY Overall Survival (OS) Time |
59.0; 49.3 | 0.5457 |
| SECONDARY Overall Safety - Number of Participants With Adverse Events (AE) |
106; 108; 50; 55; 14; 14 | — |
| SECONDARY Participant's Assessment of Health Related Quality of Life (HRQL) Using a by Using the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Questionnaire |
105.3; 101.1; -1.1; -2.8 | — |
Summary
This study evaluated outcomes in participants with advanced ovarian epithelial adenocarcinoma receiving aflibercept.
The primary objective was to compare the objective response rate of Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) 4.0 mg/kg and 2.0 mg/kg, administered intravenously (IV) every 2 weeks with historical control in participants with advanced ovarian epithelial (including fallopian tube and primary peritoneal) adenocarcinoma resistant to platinum and topotecan and/or liposomal doxorubicin.
The secondary objectives was to further assess efficacy, safety, pharmacokinetics, potential biological and pharmacogenomic markers of study drug activity, and health-related quality of life.
This study employed an Independent Review Committee (IRC) for radiological tumor assessments. For all tumor assessment-related efficacy variables, two analyses were performed: the primary analysis was based on Independent Review Committee (IRC) reviewed data and the secondary analysis was based on Investigator evaluation. If an endpoint was evaluated by the IRC, the IRC reviewed data is reported for this study.
Eligibility Criteria
Participants who met the following criteria were eligible for the study.
Inclusion Criteria
- Histologically-confirmed ovarian epithelial (including fallopian tube and primary peritoneal) adenocarcinoma.
- Prior treatment with at least 2 treatment regimens in the advanced disease treatment setting
- Platinum-resistant disease defined by relapse or progression of disease during or after treatment, or drug intolerance
- Topotecan- and/or liposomal doxorubicin-resistant disease defined by relapse or progression of disease during or after treatment, or drug intolerance
- Evidence of at least one unidimensional measurable tumor lesion by computed tomography (CT) or magnetic resonance imaging (MRI) scan according to Response Evaluation Criteria in Solid Tumors (RECIST) that has not been treated with surgery or radiation therapy
Exclusion Criteria
- Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the cervix uteri
- Prior treatment with a vascular endothelial growth factor (VEGF) or VEGF receptor inhibitor
- More than 3 chemotherapy regimens in the advanced disease treatment setting
- Uncontrolled hypertension
The above information is not intended to contain all considerations relevant to potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT00327171). 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.