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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00479583
• Other study ID #: CA187-005
• Status: Completed
• Phase: Phase 1
• First received: May 24, 2007
• Last updated: November 29, 2011
• Start date: September 2007
• Est. completion date: April 2010

Study information

• Verified date: March 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

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
• 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

Locations

Country	Name	City	State
France	Local Institution	Saint-Herblain Cedex
France	Local Institution	Villejuif
United States	University Of Alabama At Birmingham	Birmingham	Alabama
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessment		throughout the study	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	Describe anti-tumor of combination therapy		Every 8 weeks throughout the study	No
Secondary	Describe effects of combination therapy on markers of therapeutic activity. e.g. blood, plasma and biopsy samples		throughtout the study	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form