Clinical trial · Interventional
A Study of BMS-863233 in Patients With Hematologic Cancer
A Phase 1/2, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-863233 in Subjects With Refractory Hematologic Malignancies
NCT00838890CI-TRIAL-00019430terminatedPhase 1 / Phase 2ClinicalTrials.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)
To determine safety, tolerability and maximum tolerated dose of BMS-63233/XL413 in subjects with Refractory Hematologic 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 |
|---|---|---|---|
| Refractory Hematologic Cancer | Hematopoietic and Lymphoid Cell Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cdc7-inhibitor (BMS-863233) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Cdc7-inhibitor (A)
- interventionNames
- Drug: Cdc7-inhibitor (BMS-863233)
- type
- ACTIVE_COMPARATOR
- label
- Cdc7-inhibitor (B)
- interventionNames
- Drug: Cdc7-inhibitor (BMS-863233)
Primary outcomes (1)
- measure
- To determine maximum tolerated dose and anti-tumor activity of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer
- timeFrame
- Every 21 or 28 days until maximum tolerated dose is reached
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * AML by current WHO diagnostic criteria, any FAB type (except APML), Refractory ALL, Accelerated/blast phase CML and Refractory MDS with total IPSS score of 2 or higher * ECOG performance status \<= 2 * Accessible for treatment, PK sample collection and required study follow-up * Total Bilirubin ≤ 1.5 x ULN and ALT, AST ≤ 3 x ULN Exclusion Criteria: * Women who are pregnant or breastfeeding * Subjects with Acute Promyelocytic leukemia disease or CNS leukemia disease) * Hyperleukocytosis (defined as peripheral WBC \>50,000/uL) * Treatment with any other investigational agent for any indication within 30 days of protocol enrollment * Subjects a history of gastrointestinal disease * Subjects less than four weeks from allogenic or autologous stem cell transplant infusion
References
Publications (0)
Data not yet available
No reference posted for this study.