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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00838890
Other study ID # CA198-001
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT03882203 - CLAGE Sequential With Flu-Bu Conditioning for Refractory Acute Leukemia Phase 2