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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00719524
First received: July 17, 2008
Last updated: March 8, 2013
Last verified: March 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


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 ] [ 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00719524     History of Changes
Other Study ID Numbers: TCD10620, EudraCT: 2007-006676-11
Study First Received: July 17, 2008
Last Updated: March 8, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Sanofi:
Neoplasms
Antineoplastic Combined Chemotherapy Protocol

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 26, 2014