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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Refractory Hematologic Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

Every 21 or 28 days until maximum tolerated dose is reached

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA198-001

NCT ID:

NCT00838890

Start Date:

March 2009

Completion Date:

November 2009

Related Keywords:

  • Refractory Hematologic Cancer
  • Hematologic Neoplasms

Name

Location

Massachusetts General HospitalBoston, Massachusetts  02114-2617
H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612
University of MiamiMiami, Florida  33136
Roswell ParkBuffalo, New York  14263