Clinical trial · Interventional
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
NCT00479583CI-TRIAL-00005844completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-690514 / FOLFIRI | Drug | — | UNRESOLVED |
| BMS-690514 / FOLFOX | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A
- interventionNames
- Drug: BMS-690514 / FOLFIRI
- type
- ACTIVE_COMPARATOR
- label
- B
- interventionNames
- Drug: BMS-690514 / FOLFOX
Primary outcomes (3)
- measure
- Safety assessment
- timeFrame
- throughout the study
- measure
- dose-limiting toxicity (DLT)
- timeFrame
- assessed for individual patients from C1D1 to C1D28 during the dose escalation portion of the protocol, until maximum tolerated dose is identified
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.