Advanced Neoplastic Disease Clinical Trial
Official title:
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
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.
| Status | Completed |
| Enrollment | 58 |
| Est. completion date | February 2011 |
| Est. primary completion date | February 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion criteria: - Advanced neoplastic disease (i.e metastatic or locally advanced disease) for which docetaxel-based regimen therapy is indicated such as breast, non-small cell lung and prostate cancer. - ECOG performance status of 0 to 1. Exclusion criteria: - Concurrent treatment with any other anticancer therapy. - Patient with locally advanced or metastatic breast cancer who never received adjuvant chemotherapy. - Brain metastases and carcinomatous leptomeningitis. - Prior intensive chemotherapy with autologous stem cell rescue. - Patients who received a high cumulative dose of anthracycline (i.e doxorubicin > 400mg/m2 or epirubicin >750 mg/m2). - Impaired cardiovascular function. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Sanofi |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicities (DLTs) | 3 weeks (cycle 1) | Yes | |
| Secondary | Number of Participants with Adverse Events | Up to disease progression or unacceptable toxicity or study discontinuation criteria (median treatment of 4 cycles) | Yes | |
| Secondary | 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) | No | |
| Secondary | 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) | No | |
| Secondary | 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) | No | |
| Secondary | 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 | No |