Clinical trial · Interventional
A Study of BMS-863233 in Patients With Advanced and/or Metastatic Solid Tumors
A Phase 1/2 Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-863233 in Subjects With Advanced and/or Metastatic Solid Tumors
NCT00886782CI-TRIAL-00066021terminatedPhase 1 / Phase 2Results postedClinicalTrials.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 determine safety, tolerability and maximum tolerated dose of BMS-863233 in subjects advanced and/or Metastatic solid tumors.
Conditions
Conditions (2)
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 Cancers | Malignant Solid Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cdc7-inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cdc7-inhibitor
- interventionNames
- Drug: Cdc7-inhibitor
Primary outcomes (4)
- measure
- Number of Participants With Dose Limiting Toxicities (DLTs) of BMS-863233
- timeFrame
- Up to 28 days
- description
- DLT is defined based on adverse events that are deemed to be drug-related and occur during the first cycle of therapy using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
- measure
- Number of Participants With Adverse Events (AEs)
- timeFrame
- From first dose to 30 days post last dose (Up to 14 months)
- description
- Number of participants with any grade adverse events (AEs), any grade drug-related AEs, any grade serious adverse events (SAEs), any grade drug-related SAEs, and any grade AEs leading to discontinuation of any drug. The severity of AEs will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Phase 1 Inclusion Criteria: * Subjects with advanced and/or metastatic solid tumors who are either refractory to or have relapsed from standard therapies, or for whom a standard therapy does not exist. * ECOG performance status ≤ 2 * Accessible for treatment, PK sample collection and required study follow-up * Total Bilirubin ≤ 1.5 x ULN and ALT, AST ≤ 2.5 x ULN Exclusion Criteria: * Women who are pregnant or breastfeeding * Subjects with known or suspected brain metastasis, primary brain tumors, or brain as the only site of disease * Exposure to any investigational agent within 4 weeks of study drug administration * Subjects a history of gastrointestinal disease
References
Publications (0)
Data not yet available
No reference posted for this study.