An Open Label, Dose Escalation, Safety and Pharmacokinetic Phase 1 Study With AVE8062 Administered as a 30 Minutes Intravenous Infusion Followed by Docetaxel Administered as an 1 Hour Intravenous Infusion 24 Hours-Apart Every 3 Weeks in Patients With Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- AVE8062
- Conditions
- Advanced Neoplastic Disease
- Sponsor
- Sanofi
- Enrollment
- 58
- Primary Endpoint
- Number of Participants With Dose Limiting Toxicities (DLTs)
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
AVE8062 / 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
Intervention: AVE8062
AVE8062 / 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
Intervention: Docetaxel
Outcomes
Primary Outcomes
Number of Participants With Dose Limiting Toxicities (DLTs)
Time Frame: 3 weeks (cycle 1)
Secondary Outcomes
- 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))
- 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))
- 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)