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

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00719524
• Collaborator: (none)
• Enrollment: 71
• Locations: 3
• Arm: 1
• Duration (Months): 55.1
• Patients Per Site: 23.7
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms	Drug: OMBRABULIN (AVE8062)	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 71 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Feb 1, 2013
• Actual Study Completion Date: Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: OMBRABULIN (AVE8062); Dose escalation study with combination chemotherapy

Outcome Measures

Primary Outcome Measures

1. Recommended dose of the combination based on Dose Limiting Toxicities observed [Cycle 1]

Secondary Outcome Measures

1. Overall safety profile [Treatment period]

2. Pharmacokinetic profile [Cycle 1]

3. Anti-tumor activity of the combination [Every 2 cycles]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational Site Number 250001	Villejuif		France	94805
2	Investigational Site Number 380001	Milano		Italy	20133
3	Investigational Site Number 756001	Bellinzona		Switzerland	6500

Sponsors and Collaborators

• Sanofi

Investigators

• Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT00719524
• Other Study ID Numbers: TCD10620; EudraCT: 2007-006676-11
• First Posted: Jul 21, 2008
• Last Update Posted: Mar 11, 2013
• Last Verified: Mar 1, 2013

• Keywords provided by Sanofi: Neoplasms; Antineoplastic Combined Chemotherapy Protocol
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Mar 11, 2013