Clinical trial · Interventional
Study of BMS-582664 in Combination With Either FOLFIRI or FOLFOX for Gastrointestinal (GI) Malignancies
A Phase I Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Combination With 5-Fluorouracil/Leucovorin and Irinotecan or Oxaliplatin for Patients With Advanced or Metastatic Cancer
- 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 study is to define the recommended dose of BMS-582664 that could be safely combined with 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) or 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX) chemotherapy regimens in patients with advanced gastrointestinal malignancies and to evaluate the safety profile, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of these combinations.
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 |
|---|---|---|---|
| Gastrointestinal Neoplasms | Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-582664 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Safety (vitals, labs, physical examination [PE], electrocardiogram [ECG]) every week (qw)
- measure
- Echocardiogram every 2 cycles (q 2 cycles)
Secondary outcomes (4)
- measure
- Tumor response (q 2 cycles)
- measure
- PK parameters (during 1st cycle)
- measure
- PD markers (weekly)
- measure
- Fluorodeoxyglucose positron emission tomography (FDG-PET) (3 scans prior to C3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Good performance status * Advanced colorectal, pancreatic, esophageal or gastric cancer * Tissue for analyses * Adequate bone marrow, hepatic, renal function * 4-6 weeks since prior therapy * Adequate protection for women of child bearing potential (WOCBP) Exclusion Criteria: * Brain metastasis * Thromboembolic disease * Cardiovascular disease
References
Publications (0)
Data not yet available