Combination Trial of BMS-690514 in Combination With FOLFIRI and FOLFOX

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00479583
First received: May 24, 2007
Last updated: November 29, 2011
Last verified: March 2011
  Purpose

The purpose of this research study is to determine the highest dose of BMS-690514 that can be safely given in combination with the chemotherapeutic regimens (FOLFIRI and FOLFOX) to patients with advanced cancer


Condition Intervention Phase
Cancer
Drug: BMS-690514 / FOLFIRI
Drug: BMS-690514 / FOLFOX
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-690514 in Combination With FOLFIRI and FOLFOX in Subjects With Advanced Metastatic Solid Tumors

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Safety assessment [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
  • dose-limiting toxicity (DLT) [ Time Frame: assessed for individual patients from C1D1 to C1D28 during the dose escalation portion of the protocol, until maximum tolerated dose is identified ] [ Designated as safety issue: Yes ]
  • determination of maximum tolerated dose (MTD) [ Time Frame: during dose escalation portion of the protocol. Three to six subjects are treated at a specified dose level. If deemed safe dose escalation continues until the maximum tolerated dose is identified ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Describe anti-tumor of combination therapy [ Time Frame: Every 8 weeks throughout the study ] [ Designated as safety issue: No ]
  • Describe effects of combination therapy on markers of therapeutic activity. e.g. blood, plasma and biopsy samples [ Time Frame: throughtout the study ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: September 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: BMS-690514 / FOLFIRI
Tablets / IV, Oral / IV, up to 200 mg / irinotecan 180mg/m2, leucovorin 400 mg/m2, 5FU 400mg/m2 bolus, 2400 mg/m2 inf, once daily / q 2 weeks, up to 24 mos
Active Comparator: B Drug: BMS-690514 / FOLFOX
Tablets / IV, Oral / IV, up to 200 mg / oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, 5FU 400mg/m2 bolus, 2400 mg/m2 inf, once daily / q 2 weeks, up to 24 mos

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients eligible for FOLFIRI or FOLFOX therapy
  • ECOG performance status score 0-1
  • At least 4 weeks since the last chemotherapy, immunotherapy or radiotherapy with:
  • At least 4 weeks since anti-cancer hormonal therapy OR targeted therapy (for instance tamoxifen or Tarceva)
  • No maximum age for Study Arm A (FOLFOX)
  • 18-65 years of age for Study Arm B (FOLFIRI)

Exclusion Criteria:

  • Treatment with other TKIs within the past 4 weeks
  • Active inflammatory bowel disease
  • Major gastrointestinal surgery which may affect absorption of the drug, any surgery within the last 4 weeks
  • History of thromboembolism
  • Severe unmanageable diarrhea
  • Uncontrolled or significant cardiovascular disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00479583

Locations
United States, Alabama
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
France
Local Institution
Saint-Herblain Cedex, France, 44805
Local Institution
Villejuif, France, 94805
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00479583     History of Changes
Other Study ID Numbers: CA187-005
Study First Received: May 24, 2007
Last Updated: November 29, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Cancer (solid tumors)

ClinicalTrials.gov processed this record on April 17, 2014