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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: OMBRABULIN (AVE8062)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00719524

EudraCT: 2007-006676-11

TCD10620

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 1 patient group

1

Experimental group

Treatment:

Drug: OMBRABULIN (AVE8062)