NCT00327171|CompletedPhase 2Results

Study of AVE0005 (VEGF Trap) in Patients With Chemoresistant Advanced Ovarian Cancer

A Multicenter, Randomized, Double-blind, Parallel-arm, Two-stage Study of the Efficacy and Safety of AVE0005 (VEGF Trap) Administered Intravenously Every 2 Weeks in Patients With Platinum-resistant and topotecan-and/or Liposomal Doxorubicin-resistant Advanced Ovarian Cancer

Sanofi ClinicalTrials.gov

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2 other identifiers

ARD6122AVE0005

Study Type

interventional

Target

218

Locations

11 countries

Sites

Timeline

RegisteredMay 2006

StartedMay 2006

CompletionMar 2010

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

218

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started May 2006

Typical duration for phase_2

Geographic Reach

11 countries

11 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.8 years study duration

Study Start

First participant enrolled

May 1, 2006

Completed

15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2006

Completed

2 days until next milestone

First Posted

Study publicly available on registry

May 18, 2006

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed

1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed

2.6 years until next milestone

Results Posted

Study results publicly available

October 18, 2012

Completed

Last Updated

June 7, 2016

Status Verified

May 1, 2016

Enrollment Period

1.9 years

First QC Date

May 16, 2006

Results QC Date

August 17, 2012

Last Update Submit

May 4, 2016

Conditions

Neoplasms Cancer of the Ovary

Keywords

ovarian cancerangiogenesisangiogenesis inhibitionVEGF-Trap fusion recombinant proteinCancer and other neoplasms

Outcome Measures

Primary Outcomes (2)

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
OR included Complete Response (CR) and Partial Response (PR). Per RECIST, CR was disappearance of all target or non-target lesions, or normalization of tumor marker levels (for non-target lesions) and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with baseline sum LD as reference. Tumors were assessed by an independent third-party core imaging laboratory evaluating the chest, abdomen, and pelvis by Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and responses were confirmed by repeat tumor imaging 4-6 weeks later.
From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)
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
OR included Complete Response (CR) and Partial Response (PR). Per RECIST, CR was disappearance of all target or non-target lesions, or normalization of tumor marker levels (for non-target lesions) and PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, with baseline sum LD as reference. Tumors were assessed by an independent third-party core imaging laboratory evaluating the chest, abdomen, and pelvis by Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and responses were confirmed by repeat tumor imaging 4-6 weeks later.
From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)

Secondary Outcomes (10)

Number of Participants With a Clinical Benefit Response (CBR) as Per RECIST Based on the Analysis by the IRC
From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)
Duration of Response (DR) Based on the Analysis by an Independent Review Committee (IRC)
From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)
Tumor Marker Response Rate (TMRR) Based on the Gynecologic Cancer Intergroup (GCIG) Definition
From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)
Time to Tumor Progression (TTP) as Per RECIST Based on the Analysis by the IRC
From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)
Time to Tumor Marker (CA-125) Progression (TTMP)
From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)
+5 more secondary outcomes

Study Arms (2)

Aflibercept 2.0 mg/kg

EXPERIMENTAL

Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept.

Drug: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)

Aflibercept 4.0 mg/kg

EXPERIMENTAL

Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept.

Drug: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)

Interventions

Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)DRUG

Aflibercept 4.0 mg/kg administered intravenously (IV) over 1 hour once every 2 weeks. Aflibercept could be reduced by 1 dose level ( to 2.0 mg/kg) or 2 dose levels (to 1.0 mg/kg) in case of uncontrolled hypertension or urinary protein \>3.5 g/24 hours. Intrapatient dose escalation was not to be permitted. Participants requiring more than 2 dose level reductions would be withdrawn from study treatment.

Aflibercept 4.0 mg/kg

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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.

Contact the study team to confirm eligibility.