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A Phase II Study of BMS-354825 in Subjects With Accelerated Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate


Phase 2
18 Years
N/A
Not Enrolling
Both
Chronic Myelogenous Leukemia

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Trial Information

A Phase II Study of BMS-354825 in Subjects With Accelerated Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate


Inclusion Criteria:



- Subjects with Philadelphia chromosome positive (PH+) or the fused gene BCR/ABL
positive (BCR/ABL+) accelerated phase chronic myeloid leukemia (CML) whose disease
has primary or acquired hematologic resistance to imatinib mesylate or who are
intolerant of imatinib mesylate.

- Subjects must have had prior exposure to imatinib. However, imatinib mesylate does
not need to be their most recent CML treatment prior to coming on this study.

- Men and women, 18 years of age or older.

- Adequate hepatic function.

- Adequate renal 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 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:

- Women who are pregnant or breastfeeding.

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

- A serious uncontrolled medical disorder or active infection that would impair the
ability of the subjects 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 or rendering
of informed consent.

- History of significant bleeding disorder unrelated to CML.

- Concurrent incurable malignancy other than CML.

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

- Prior therapy with dasatinib (BMS-354825).

- 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/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Major and Overall Hematologic Response (MaHR and OHR)

Outcome Description:

MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL). OHR=best confirmed response of MaHR or minor hematologic response (MiHR). Confirmed hematologic response=response confirmed ≥4 weeks after first documented event with no concomitant use of anagrelide or hydroxyurea. Maintaining a response=no 2 consecutive records of nonresponse at assessment. Criteria for CHR and NEL specified in Outcome Measure 2 and criteria for MiHR in Outcome Measure 4.

Outcome Time Frame:

Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA180-005

NCT ID:

NCT00101647

Start Date:

December 2004

Completion Date:

March 2008

Related Keywords:

  • Chronic Myelogenous Leukemia
  • Chronic myelogenous leukemia (CML): Accelerated phase
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myeloid, Accelerated Phase
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

Local InstitutionChicago, Illinois  
Local InstitutionBaltimore, Maryland  
Local InstitutionBronx, New York  
Local InstitutionPortland, Oregon  
Local InstitutionBirmingham, Alabama  
Local InstitutionCorona, California  
Local InstitutionFort Lauderdale, Florida  
Local InstitutionWichita, Kansas  
Local InstitutionSpringfield, Massachusetts  
Local InstitutionNew Brunswick, New Jersey  
Local InstitutionDuncansville, Pennsylvania  
Local InstitutionAustin, Texas  
Local InstitutionRome, Georgia  
Local InstitutionChattanooga, Tennessee  
Local InstitutionColumbia, Missouri  
Local InstitutionDetroit, Michigan