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

Neoplasms Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00719524
• Other study ID #: TCD10620
• Secondary ID: EudraCT: 2007-00
• Status: Completed
• Phase: Phase 1
• First received: July 17, 2008
• Last updated: March 8, 2013
• Start date: July 2008
• Est. completion date: February 2013

Study information

• Verified date: March 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• OMBRABULIN (AVE8062)
Dose escalation study with combination chemotherapy

Locations

Country	Name	City	State
France	Investigational Site Number 250001	Villejuif
Italy	Investigational Site Number 380001	Milano
Switzerland	Investigational Site Number 756001	Bellinzona

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

France,  Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recommended dose of the combination based on Dose Limiting Toxicities observed		Cycle 1	Yes
Secondary	Overall safety profile		Treatment period	Yes
Secondary	Pharmacokinetic profile		Cycle 1	Yes
Secondary	Anti-tumor activity of the combination		Every 2 cycles	No