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A Study of BMS-863233 in Patients With Hematologic Cancer

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ClinicalTrials.gov Identifier: NCT00838890
Recruitment Status : Terminated
First Posted : February 9, 2009
Last Update Posted : October 12, 2015
Sponsor:
Collaborator:
Exelixis
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Refractory Hematologic Cancer Drug: Cdc7-inhibitor (BMS-863233) Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Arm Intervention/treatment
Active Comparator: Cdc7-inhibitor (A) Drug: Cdc7-inhibitor (BMS-863233)
Tablets, Oral, QD x 14 days until MTD is achieved, 14 days per 28 day cycle/QD, 12 months
Other Name: BMS-863233
Active Comparator: Cdc7-inhibitor (B) Drug: 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
Other Name: BMS-863233



Primary Outcome Measures :
  1. To determine maximum tolerated dose and anti-tumor activity of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer [ Time Frame: Every 21 or 28 days until maximum tolerated dose is reached ]

Secondary Outcome Measures :
  1. To determine the safety of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer [ Time Frame: Every 21 or 28 days until the MTD is reached ]
  2. To determine the pharmacokinetics of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer [ Time Frame: Every 21 or 28 days until the MTD is reached ]
  3. To determine the anti-tumor activity of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer [ Time Frame: Every 21 or 28 days until the MTD is reached ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00838890


Locations
United States, Florida
University Of Miami
Miami, Florida, United States, 33136
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
Roswell Park
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Bristol-Myers Squibb
Exelixis
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00838890     History of Changes
Other Study ID Numbers: CA198-001
First Posted: February 9, 2009    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Hematologic Diseases