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
1 other identifier
interventional
11
1 country
4
Brief Summary
To determine safety, tolerability and maximum tolerated dose of BMS-63233/XL413 in subjects with Refractory Hematologic Cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2009
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2009
CompletedFirst Posted
Study publicly available on registry
February 9, 2009
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedOctober 12, 2015
September 1, 2015
10 months
February 6, 2009
September 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (2)
Cdc7-inhibitor (A)
ACTIVE COMPARATORCdc7-inhibitor (B)
ACTIVE COMPARATORInterventions
Tablets, Oral, QD x 14 days until MTD is achieved, 14 days per 28 day cycle/QD, 12 months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- Exelixiscollaborator
Study Sites (4)
University Of Miami
Miami, Florida, 33136, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Roswell Park
Buffalo, New York, 14263, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2009
First Posted
February 9, 2009
Study Start
March 1, 2009
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
October 12, 2015
Record last verified: 2015-09