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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00479583
First Posted: May 28, 2007
Last Update Posted: November 30, 2011
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:
Bristol-Myers Squibb
  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
Intervention Model: Single Group Assignment
Masking: None (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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Safety assessment [ Time Frame: throughout the study ]
  • 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 ]
  • 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 ]

Secondary Outcome Measures:
  • Describe anti-tumor of combination therapy [ Time Frame: Every 8 weeks throughout the study ]
  • Describe effects of combination therapy on markers of therapeutic activity. e.g. blood, plasma and biopsy samples [ Time Frame: throughtout the study ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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): 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:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00479583     History of Changes
Other Study ID Numbers: CA187-005
First Submitted: May 24, 2007
First Posted: May 28, 2007
Last Update Posted: November 30, 2011
Last Verified: March 2011

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