AVE8062 in Combination With Platinum-taxane Doublet in Advanced Solid Tumor

Study Overview
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Brief Summary
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The purpose of this study is to determine the recommended dose of the combination of AVE8062 with platinum salts (cisplatin or carboplatin) and taxanes (docetaxel or paclitaxel) in patients with advanced solid tumors for which platinum-taxane doublet constitutes mainstay of care.

Official Title
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An Open-label, Non-randomized, Dose Evaluation, Safety and Pharmacokinetics Phase I Study of AVE8062 in Combination With Platinum Salts (Cisplatin or Carboplatin) and Taxanes (Docetaxel or Paclitaxel), Every 3 Weeks, in Patients With Advanced Solid Tumors.

Conditions
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Neoplasms

Intervention / Treatment
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* Drug: OMBRABULIN (AVE8062)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Advanced neoplastic disease (i.e. metastatic or locally advanced disease) for which platinum-taxane doublet regimens are approved or constitutes the mainstay of care such as non small cell lung cancer, epithelial ovary cancer, gastric cancer, transitional cell and bladder cancer and head and neck cancer. Eastern cooperative oncology group (ECOG) performance status of 0 to 1. Exclusion Criteria: Concurrent treatment with any other anticancer therapy, including chemotherapy, immunotherapy, radiotherapy (excluding radiotherapy with palliative intent on non-target lesions), targeted therapy, gene therapy, or patients planning to receive these treatments during the study. Absence of histologically or cytologically proven cancer at the first diagnosis. Negative serum/urinary pregnancy test Washout period of 3 weeks for prior anti-tumor therapy or any investigational treatment The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: OMBRABULIN (AVE8062)<br>* Dose escalation study with combination chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recommended dose of the combination based on Dose Limiting Toxicities observed |  | Cycle 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall safety profile |  | Treatment period | 
| Pharmacokinetic profile |  | Cycle 1 | 
| Anti-tumor activity of the combination |  | Every 2 cycles | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoplasms, Antineoplastic Combined Chemotherapy Protocol