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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00479583

Enrollment

Registered

2007-05-28

Start date

2007-09-30

Completion date

2010-04-30

Last updated

2011-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Cancer (solid tumors)

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

Interventions

DRUGBMS-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

DRUGBMS-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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

France, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026