We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00719524
First Posted: July 21, 2008
Last Update Posted: March 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi
  Purpose
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 Intervention Phase
Neoplasms Drug: OMBRABULIN (AVE8062) Phase 1

Study Type: Interventional
Study Design: 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.

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Recommended dose of the combination based on Dose Limiting Toxicities observed [ Time Frame: Cycle 1 ]

Secondary Outcome Measures:
  • Overall safety profile [ Time Frame: Treatment period ]
  • Pharmacokinetic profile [ Time Frame: Cycle 1 ]
  • Anti-tumor activity of the combination [ Time Frame: Every 2 cycles ]

Enrollment: 71
Study Start Date: July 2008
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: OMBRABULIN (AVE8062)
Dose escalation study with combination chemotherapy

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00719524


Locations
France
Investigational Site Number 250001
Villejuif, France, 94805
Italy
Investigational Site Number 380001
Milano, Italy, 20133
Switzerland
Investigational Site Number 756001
Bellinzona, Switzerland, 6500
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00719524     History of Changes
Other Study ID Numbers: TCD10620
EudraCT: 2007-006676-11
First Submitted: July 17, 2008
First Posted: July 21, 2008
Last Update Posted: March 11, 2013
Last Verified: March 2013

Keywords provided by Sanofi:
Neoplasms
Antineoplastic Combined Chemotherapy Protocol

Additional relevant MeSH terms:
Taxane
Antineoplastic Agents