Dose Escalation, Safety and Pharmacokinetic Study of AVE8062 Combined With Docetaxel in Patients With Advanced Solid Tumors
- Registration Number
- NCT01907685
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To determine the dose limiting toxicity (DLT), the maximum administered dose (MAD) and the maximum tolerated dose (MTD) of AVE8062 and docetaxel in combination administered sequentially on D1 \& D2 respectively every 3 weeks in patients with advanced solid tumors.
Secondary Objectives:
* To define the overall safety profile of the combination.
* To characterize the pharmacokinetic (PK) profile of AVE8062 and docetaxel when administered in combination.
* To evaluate anti-tumor activity of the combination.
* To evaluate potential predictive biomarkers.
The study includes a tumoral pharmacogenomic sub-study conducted in a subset of sites. The objective to analyse a set of biological biomarkers in order to identify a potential predictive signature of efficacy for AVE8062 in combination with docetaxel.
- Detailed Description
The duration of study for each patient will include 4-week screening phase prior to first inclusion of study drug, 21-day study treatment cycles, end of treatment visit and follow-up phase. Each patient will be treated until disease progression, unacceptable toxicity or other study discontinuation criteria.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AVE8062 / Docetaxel Docetaxel AVE8062 30-minute IV, 11.5 to 42 mg/m2, followed by Docetaxel, 1-hour IV, 75 and 100 mg/m2 in 3-week cycles until disease progression or unacceptable toxicity or study discontinuation criteria AVE8062 / Docetaxel AVE8062 AVE8062 30-minute IV, 11.5 to 42 mg/m2, followed by Docetaxel, 1-hour IV, 75 and 100 mg/m2 in 3-week cycles until disease progression or unacceptable toxicity or study discontinuation criteria
- Primary Outcome Measures
Name Time Method Number of Participants With Dose Limiting Toxicities (DLTs) 3 weeks (cycle 1)
- Secondary Outcome Measures
Name Time Method Number of Participants with Adverse Events Up to disease progression or unacceptable toxicity or study discontinuation criteria (median treatment of 4 cycles) Plasma concentration of AVE8062 and its metabolite Before AVE8062 infusion, immediately prior to the end of AVE8062 infusion, 5, 10, 25, 45 and 60 minutes then 2, 4, 6, 8-10 and 24 hours post AVE8062 infusion (cycle 1) Plasma concentration of docetaxel Before docetaxel infusion (corresponding to 24 hours post AVE8062 infusion), 15 minutes before the end of docetaxel infusion, 15 and 45 minutes post docetaxel infusion (cycle 1) Response evaluation criteria in solid tumors (RECIST) defined objective response Up to disease progression or unacceptable toxicity or study discontinuation criteria (median treatment of 4 cycles) Biomarkers expression profile of each patient in order to identify preliminary correlation with antitumor activity of the combination treatment in patients with available pre-treatment biopsy End of treatment or until disease progression or unacceptable toxicity or study discontinuation criteria