A Study of BMS-863233 in Patients With Hematologic Cancer

Refractory Hematologic Cancer Clinical Trial

Official title:

A Phase 1/2, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-863233 in Subjects With Refractory Hematologic Malignancies

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00838890
• Other study ID #: CA198-001
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: February 6, 2009
• Last updated: September 23, 2015
• Start date: March 2009
• Est. completion date: January 2010

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Refractory Hematologic Cancer

Intervention

Drug:
• Cdc7-inhibitor (BMS-863233)
Tablets, Oral, QD x 14 days until MTD is achieved, 14 days per 28 day cycle/QD, 12 months
• Cdc7-inhibitor (BMS-863233)
Tablets, Oral, MTD of Cdc7-inhibitor (A) Arm, QD x 7 days until MTD achieved, 7 days per 21 day cycle/QD, 12 months

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Roswell Park	Buffalo	New York
United States	University Of Miami	Miami	Florida
United States	H. Lee Moffitt Cancer Center & Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Exelixis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	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	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form