Status:
COMPLETED
Dose Escalation, Safety and Pharmacokinetic Study of AVE8062 Combined With Docetaxel in Patients With Advanced Solid Tumors
Lead Sponsor:
Sanofi
Conditions:
Advanced Neoplastic Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 sequent...
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 patie...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT01907685
Start Date
June 1 2006
End Date
February 1 2011
Last Update
July 25 2013
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