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

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00838890

Enrollment

Registered

2009-02-09

Start date

2009-03-31

Completion date

2010-01-31

Last updated

2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory Hematologic Cancer

Brief summary

To determine safety, tolerability and maximum tolerated dose of BMS-63233/XL413 in subjects with Refractory Hematologic Cancer

Interventions

DRUGCdc7-inhibitor (BMS-863233)

Tablets, Oral, QD x 14 days until MTD is achieved, 14 days per 28 day cycle/QD, 12 months

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To determine maximum tolerated dose and anti-tumor activity of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer	Every 21 or 28 days until maximum tolerated dose is reached

Secondary

Measure	Time frame
To determine the safety of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer	Every 21 or 28 days until the MTD is reached
To determine the pharmacokinetics of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer	Every 21 or 28 days until the MTD is reached
To determine the anti-tumor activity of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer	Every 21 or 28 days until the MTD is reached

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026