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Phase I Study of BMS-354825 in Patients With Chronic Accelerated, or Blast Phase Chronic Myelogenous Leukemia or Philadelphia Positive Acute Lymphoblastic Leukemia


Phase 1
14 Years
N/A
Not Enrolling
Both
Leukemia, Myeloid, Chronic-phase, Leukemia, Lymphoblastic, Acute, Philadelphia-positive

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Trial Information

Phase I Study of BMS-354825 in Patients With Chronic Accelerated, or Blast Phase Chronic Myelogenous Leukemia or Philadelphia Positive Acute Lymphoblastic Leukemia


Inclusion Criteria:



- Patients with Philadelphia chromosome positive, chronic, accelerated or blast phase
BML or ALL.

- Patients must have primary or acquired hematologic resistance to imatinib mesylate or
have intolerance of imatinib mesylate.

- Men and women, 14 years of age or older.

- Adequate renal function.

- Adequate hepatic function.

- Women of childbearing potential (WOCBP) must be using an adequate method of
contraception to avoid pregnancy throughout the study and for a period of at least 1
month before and at least 3 months after the study in such a manner that the risk of
pregnancy is minimized.

Exclusion Criteria:

- Patients who are eligible and willing to undergo transplantation during the screening
period.

- Women who are pregnant or breastfeeding.

- A serious uncontrolled medical disorder or active infection that would impair the
ability of the subject to receive protocol therapy.

- Uncontrolled or significant cardiovascular disease.

- Medications that increase bleeding risk.

- Medications that change heart rhythms.

- Dementia or altered mental status that would prohibit the understanding of rendering
of informed consent.

- History of significant bleeding disorder or unrelated to CML.

- Evidence of organ dysfunction or digestive dysfunction that would prevent
administration of study therapy.

- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
treatment of either a psychiatric or physical (e.g., infectious disease) illness must
not be enrolled into this study.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Establishment of MTD and recommended Phase II dose.

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA180-002

NCT ID:

NCT00103701

Start Date:

November 2003

Completion Date:

March 2006

Related Keywords:

  • Leukemia, Myeloid, Chronic-Phase
  • Leukemia, Lymphoblastic, Acute, Philadelphia-positive
  • Chronic myelogenous leukemia (CML) chronic, accelerated, blast phase
  • Philadelphia chromosome positive acute (Ph+ALL)
  • Blast Crisis
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid, Chronic-Phase

Name

Location

Local InstitutionCorona, California  
Local InstitutionAustin, Texas