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A Study of BMS-863233 in Patients With Hematologic Cancer

Primary Purpose

Refractory Hematologic Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cdc7-inhibitor (BMS-863233)
Cdc7-inhibitor (BMS-863233)
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Hematologic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Of Miami
  • H. Lee Moffitt Cancer Center & Research Institute
  • Massachusetts General Hospital
  • Roswell Park

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cdc7-inhibitor (A)

Cdc7-inhibitor (B)

Arm Description

Outcomes

Primary Outcome Measures

To determine maximum tolerated dose and anti-tumor activity of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer

Secondary Outcome Measures

To determine the safety of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer
To determine the pharmacokinetics of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer
To determine the anti-tumor activity of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer

Full Information

First Posted
February 6, 2009
Last Updated
September 23, 2015
Sponsor
Bristol-Myers Squibb
Collaborators
Exelixis
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1. Study Identification

Unique Protocol Identification Number
NCT00838890
Brief Title
A Study of BMS-863233 in Patients With Hematologic Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Study Start Date
March 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Exelixis

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Hematologic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cdc7-inhibitor (A)
Arm Type
Active Comparator
Arm Title
Cdc7-inhibitor (B)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Cdc7-inhibitor (BMS-863233)
Other Intervention Name(s)
BMS-863233
Intervention Description
Tablets, Oral, QD x 14 days until MTD is achieved, 14 days per 28 day cycle/QD, 12 months
Intervention Type
Drug
Intervention Name(s)
Cdc7-inhibitor (BMS-863233)
Other Intervention Name(s)
BMS-863233
Intervention Description
Tablets, Oral, MTD of Cdc7-inhibitor (A) Arm, QD x 7 days until MTD achieved, 7 days per 21 day cycle/QD, 12 months
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
University Of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
H. Lee Moffitt Cancer Center & Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Roswell Park
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study of BMS-863233 in Patients With Hematologic Cancer

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