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

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

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
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


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

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 identifier: NCT00479583

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
Local Institution
Saint-Herblain Cedex, France, 44805
Local Institution
Villejuif, France, 94805
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb 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) processed this record on April 17, 2014