AVE8062 in Association With Doublet Chemotherapy Cisplatin and Docetaxel in Advanced Solid Tumor - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00719524

Purpose

The purpose of this study is to determine the recommended dose of the combination of AVE8062 with cisplatin and docetaxel in patients with advanced solid tumors for which cisplatin-docetaxel doublet constitutes mainstay of care.

Condition	Intervention	Phase
Neoplasms	Drug: AVE8062	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Docetaxel Cisplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Non-Randomized, Dose Evaluation, Safety and Pharmacokinetics Phase I Study of AVE8062 in Combination With Cisplatin Administered on Day 1 Followed by Docetaxel on Day 2, Every 3 Weeks, in Patients With Advanced Solid Tumors.

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Recommended dose of the combination based on Dose Limiting Toxicities observed [ Time Frame: Cycle 1 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Overall safety profile [ Time Frame: Treatment period ] [ Designated as safety issue: Yes ]
Pharmacokinetic profile [ Time Frame: Cycle 1 ] [ Designated as safety issue: Yes ]
Anti-tumor activity of the combination [ Time Frame: Every 2 cycles ] [ Designated as safety issue: No ]

Estimated Enrollment:	28
Study Start Date:	July 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: AVE8062 Dose escalation study with combination chemotherapy

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients in good condition with advanced metastatic disease for which cisplatin-docetaxel doublet constitutes a mainstay of care (non small cell lung cancer, epithelial ovary cancer, gastric cancer, head and neck cancer)

Exclusion Criteria:

Less than 3 weeks elapsed from prior treatment with radiotherapy, surgery, or chemotherapy to the time of randomization
Brain metastases and carcinomatous leptomeningitis
Uncontrolled hypertension
Known platinum hypersensitivity
Severe hypersensitivity due to taxanes and polysorbate 80

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719524

Contacts

Contact: Public registry ICD

GV-Contact-us@sanofi-aventis.com

Locations

France
Sanofi-Aventis Administrative Office	Recruiting
Paris, France
Contact GV-Contact-us@sanofi-aventis.com
Italy
Sanofi-Aventis Administrative Office	Recruiting
Milano, Italy
Contact GV-Contact-us@sanofi-aventis.com
Switzerland
Sanofi-Aventis Administrative Office	Recruiting
Geneva, Switzerland
Contact GV-Contact-us@sanofi-aventis.com

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	TCD10620, EudraCT: 2007-006676-11
Study First Received:	July 17, 2008
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00719524
Health Authority:	Italy: Ethics Committee

Keywords provided by Sanofi-Aventis:

Neoplasms
Antineoplastic Combined Chemotherapy Protocol

Study placed in the following topic categories:

Docetaxel
Cisplatin

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on January 13, 2009