Trials / Completed
CompletedNCT01193595
Dose-escalation, Safety, Pharmacokinetics Study of AVE8062 Combined With Bevacizumab in Patients With Advanced Solid Tumors
An Open-label, Non-randomized, Dose Escalation, Safety and Pharmacokinetic Phase I Study of Ombrabulin (AVE8062) in Combination With Bevacizumab Administered by Intravenous Infusion Every 3 Weeks in Patients With Advanced Solid Tumors.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Primary Objective: \- To determine the maximum administered dose (MAD) and the maximum tolerated dose (MTD) of ombrabulin in combination with best tolerated dose of bevacizumab based on the incidence of related Dose Limiting Toxicities (DLTs). Secondary Objectives: * To assess the overall safety profile of the combination * To characterize the pharmacokinetic (PK) profile of both ombrabulin and bevacizumab when given in combination * To evaluate preliminary evidence of anti-tumor activity * To assess the pharmacodynamic effect using (Dynamic Contrast Enhanced Ultra-Sound) DCE-US, measuring biomarkers
Detailed description
The duration of the study for each patient will include an up to 28-day screening phase, 21-day study treatment cycles, an end of treatment visit with a follow-up period. Each patient will participate in only one dose group and will receive AVE8062 with bevacizumab every 3 weeks until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ombrabulin (AVE8062) | Pharmaceutical form:Solution for infusion Route of administration: Intravenous |
| DRUG | bevacizumab | Pharmaceutical form:Solution for infusion Route of administration: Intravenous |
Timeline
- Start date
- 2010-09-01
- Primary completion
- 2014-10-01
- Completion
- 2014-10-01
- First posted
- 2010-09-02
- Last updated
- 2014-12-03
Locations
4 sites across 3 countries: France, Italy, United Kingdom
Source: ClinicalTrials.gov record NCT01193595. Inclusion in this directory is not an endorsement.