Phase 2
Completed N=16
AVE0005 (VEGF Trap) in Patients With Recurrent Symptomatic Malignant Ascites
Source: ClinicalTrials.gov NCT00396591 ↗Enrolled (actual)
16
Serious AEs
93.8%
Results posted
Jan 2013
Primary outcomePrimary: Percentage of Participants With a Repeat Paracentesis Response (RPR) — 62.5 percentage of participants
Summary
The primary objective of this study was to compare the time between paracenteses before and after administration of Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) in ovarian cancer participants with symptomatic malignant ascites.
The secondary objectives were to further assess efficacy and safety of Aflibercept treatment, and the exploratory objectives were to assess pharmacokinetics, immunogenicity and health-related quality of life.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Repeat Paracentesis Response (RPR) |
62.5 | — |
| SECONDARY Time to Repeat Paracentesis (TRP) |
76.0 | — |
| SECONDARY 60-day Frequency of Paracentesis (FOP) |
1.5 | — |
| SECONDARY Progression-free Survival (PFS) Time |
59.5 | — |
| SECONDARY Overall Survival (OS) Time |
92.0 | — |
| SECONDARY Number of Participants With a Positive Anti-drug Antibody Response |
— | — |
| SECONDARY Safety - Number of Participants With Adverse Events (AE) |
16; 15; 8; 2 | — |
Eligibility Criteria
Participants that met the following criteria were eligible.
Inclusion Criteria
- Symptomatic malignant ascites resulting from advanced ovarian epithelial cancer (including fallopian tube and primary peritoneal adenocarcinoma) that required at least 3 previous therapeutic paracenteses at a frequency of 1 to 4 paracenteses per month for management.
- 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.
Exclusion Criteria
- Peritoneovenous or other type of shunt that was placed for the management of ascites
- Prior treatment with a VEGF or VEGF receptor inhibitor
- Uncontrolled hypertension
The above information is not intended to contain all considerations relevant to participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT00396591). 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. Informational only — not medical advice.