Combination Trial of BMS-690514 in Combination With FOLFIRI and FOLFOX - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00479583

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 I

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study
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 ] [ 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 ]

Estimated Enrollment:	60
Study Start Date:	September 2007
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	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
B: Active Comparator	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

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations

United States, Alabama
University Of Alabama At Birmingham	Recruiting
Birmingham, Alabama, United States, 35294
Contact: James Posey, Site 003
United States, Pennsylvania
Fox Chase Cancer Center	Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Steven J. Cohen, Site 004 215-214-1676
France
Local Institution	Recruiting
Saint-Herblain Cedex, France, 44805
Contact: Site 001
Local Institution	Recruiting
Villejuif, France, 94805
Contact: Site 002

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA187-005
Study First Received:	May 24, 2007
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00479583 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Cancer (solid tumors)

Study placed in the following topic categories:

Oxaliplatin
Fluorouracil
Irinotecan
Leucovorin

ClinicalTrials.gov processed this record on May 07, 2009