AVE0005 (VEGF Trap) in Patients With Recurrent Symptomatic Malignant Ascites

Sanofi

Status and phase: Completed; Phase 2

Conditions: Ovarian Neoplasms

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00396591

ARD6772

EUDRACT: 2006-000604-16

Details and patient eligibility

About

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.

Full description

The study consisted of:

• A 30-day screening phase prior to Day 1
• Day 1 registration and pre-treatment paracentesis
• Aflibercept administration within 1-day of registration
• Two-week study treatment cycles (for efficacy data, the cut-off date was 6 months post-registration
• A 60-day post-treatment follow-up phase

During the study, participants were treated with Aflibercept study treatment through the duration of the study unless they met one the following criteria for discontinuation:

• Participant (or legal representative) chose to withdraw from treatment
• The investigator or sponsor thought that continuation of the study would be detrimental to the participants well-being
• Participant had intercurrent illness that prevented further administration of investigational product (IP)
• Participant had more than 2 IP dose reductions
• Participant had unacceptable adverse events (AEs)
• Participant had arterial thromboembolic events, including cerebrovascular accidents, myocardial infarctions, transient ischemic attacks, new onset angina, or worsening of preexisting angina
• Participant required surgical intervention for intestinal obstruction or gastrointestinal perforation

Enrollment: 16 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Aflibercept

Experimental group

Description:

Participants with advanced ovarian epithelial cancer (including fallopian tube and primary peritoneal adenocarcinoma) treated with Aflibercept every 2 weeks until a criterion for treatment discontinuation was met

Treatment:

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