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Long-Term Safety and Efficacy of Dasatinib (BMS-354825) in Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia in Subjects Who Experienced Clinical Benefit on Protocol CA180-002

Phase 1
18 Years
Not Enrolling

Thank you

Trial Information

Long-Term Safety and Efficacy of Dasatinib (BMS-354825) in Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia in Subjects Who Experienced Clinical Benefit on Protocol CA180-002

This study enrolled participants with Philadelphia chromosome positive (Ph+)chronic
myelogenous leukemia (CML) or Ph+ acute lymphoblastic leukemia (ALL) who had demonstrated
hematologic resistance or intolerance to imatinib mesylate (Gleevec) and had experienced
clinical benefit (in Investigator's opinion) on protocol CA180002.

Inclusion Criteria:

- Signed written informed consent

- Previous treatment with dasatinib on protocol CA180-002 and receiving clinical
benefit in the opinion of the investigator

- Completed a minimum of 3 months on protocol CA180-002

- Eastern Cooperative Oncology Group (ECOG)performance status 0, 1, or 2 (See Appendix

- Prior history of Ph+ chronic, accelerated, or blast phase CML or Ph+ ALL

Exclusion Criteria:

- Women of childbearing potential(WOCBP)who are unwilling or unable to use an
acceptable method to avoid pregnancy for the entire study period and for up to 12
weeks after the study

- WOCBP using a prohibited contraceptive method

- Women who are pregnant or breastfeeding

- Met the criteria as defined in protocol CA180-002 for discontinuation of therapy
which includes:

- Withdrawal of informed consent (subject's decision to withdraw for any reason)

- Any clinical adverse event, laboratory abnormality or intercurrent illness which, in
the opinion of the investigator, indicates that continued treatment with dasatinib is
not in the best interest of the subject

- Imprisonment or the compulsory detention for treatment of either a psychiatric or
physical (e.g., infectious disease) illness

Medical History and Concurrent Diseases

- A serious uncontrolled medical disorder or active infection which would impair the
ability of the patient to receive protocol therapy;

- Uncontrolled angina within 3 months

- Diagnosed or suspected congenital long QT syndrome

- Any history of clinically significant ventricular arrhythmias (such as ventricular
tachycardia, ventricular fibrillation, or Torsades de pointes)

- Prolonged corrected QT(QTc) interval on pre-entry electrocardiogram (> 450 msec)

- Uncontrolled hypertension

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

- History of significant bleeding disorder unrelated to CML, including:

1. Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)

2. Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor
VIII antibodies)

Physical and Laboratory Test Findings

- Total bilirubin ≥ 1.5 mg/dl

- alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 2 times the
institutional upper limits of normal

- Serum creatinine ≥ 1.5 times the institutional upper limits of normal

Prohibited Therapies and/or Medications

- Patients currently taking drugs that are generally accepted to have a risk of causing
Torsades de Pointes including:

- quinidine, procainamide, disopyramide

- amiodarone, sotalol, ibutilide, dofetilide

- erythromycins, clarithromycin

- chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide

- cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone,
halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine.

- Medications that inhibit platelet function and any non-steroidal anti-inflammatory
drug) or anticoagulants are prohibited unless a previous exception on CA180-002 was
granted by the medical monitor. Subjects taking anagrelide for thrombocytosis due to
CML are eligible for this protocol

Type of Study:


Study Design:

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

Outcome Measure:

Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation.

Outcome Description:

AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to AEs were recorded. These data differ from that in the Participant Flow section. This is because the data were collected on 2 different pages of the Case Report Form and were not reconciled.

Outcome Time Frame:

From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months.

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

December 2005

Completion Date:

September 2008

Related Keywords:

  • Leukemia
  • Leukemia
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Philadelphia Chromosome