Clinical trial · Interventional
Ascending Multiple-Dose Study of BMS-817378 in Subjects With Advanced Cancers
A Phase I Ascending Multiple-Dose Study of BMS-817378 in Subjects With Advanced or Metastatic Solid Tumors
NCT00792558CI-TRIAL-00019002withdrawnPhase 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 study is to find the maximum tolerated dose of BMS-817378 in subjects with advanced cancers
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 |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-817378 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- interventionNames
- Drug: BMS-817378
Primary outcomes (1)
- measure
- To establish the MTD of BMS-817378 when administered orally on a daily schedule in subjects with advanced cancers
- timeFrame
- Within the first 21 days after first dose of BMS-817378
Secondary outcomes (5)
- measure
- Assess safety and tolerability of multiple doses of BMS-817378 administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors
- timeFrame
- All time points while subject is on study
- measure
- Assess the safety and tolerability of co-administration of a CYP substrate cocktail and BMS-817378 given at or below the MTD (dose expansion cohort)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of advanced non-hematologic malignancy. Dose expansion cohort restricted to subjects with advanced or metastatic gastroesophageal cancer, squamous cell cancers of the head and neck, and castration resistant prostate cancer * ECOG status 0-1 Exclusion Criteria: * WOCBP unwilling/unable to use acceptable contraception methods, and women pregnant or breast feeding * Symptomatic brain metastasis * Uncontrolled or significant cardiovascular disease * History of thromboembolic events or bleeding diathesis in past 6 months * Conditions requiring prophylactic anticoagulation or chronic anti-platelet therapy * Serious non-healing wounds, ulcers or bone fractures in past 3 months * Hemorrhage or bleeding event \>= CTCAE grade 3 in past 4 weeks * Proteinuria \>= 2+ on dipstick or \>= 1gm/24 hours * Concurrent chemotherapy, hormonal therapy, immunotherapy, radiation therapy or therapy with any other investigational product * Concurrent herbal, alternative, food supplements, or strong CYP 3A4 inhibitors or inducers
References
Publications (0)
Data not yet available
No reference posted for this study.