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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT00479583

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

6.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Cancer	Drug: BMS-690514 / FOLFIRI Drug: BMS-690514 / FOLFOX	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

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

Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Safety assessment [throughout the study]
dose-limiting toxicity (DLT) [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) [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 [Every 8 weeks throughout the study]
Describe effects of combination therapy on markers of therapeutic activity. e.g. blood, plasma and biopsy samples [throughtout the study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University Of Alabama At Birmingham	Birmingham	Alabama	United States	35294
2	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
3	Local Institution	Saint-Herblain Cedex		France	44805
4	Local Institution	Villejuif		France	94805

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00479583

Other Study ID Numbers:

CA187-005

First Posted:

May 28, 2007

Last Update Posted:

Nov 30, 2011

Last Verified:

Mar 1, 2011

Keywords provided by , ,

Cancer (solid tumors)

Study Results

No Results Posted as of Nov 30, 2011