Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Study

NCT ID: NCT00978731

Last Updated: 2011-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2008-09-30

Brief Summary

To determine the long term safety and tolerability of dasatinib exposure in subjects previously treated in CA180-002.

Conditions

Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dasatinib

Group Type: EXPERIMENTAL

Dasatinib

Intervention Type: DRUG

Tablets, Oral, The dosing ranges from 50mg to a total of 240mg daily with the following 3 schedules:

• 5 days on, 2 days off
• 6 days on, 1 day off
• Continuous daily dosing

Once Daily (QD) or Twice Daily (BID) dosing, Subjects will be treated until progression of disease despite escalation/reductions of dose to the level deemed safe by available data, until intolerable/unacceptable toxicity or until subject withdrawal from the study or discontinuation of the study

Interventions

Dasatinib

Tablets, Oral, The dosing ranges from 50mg to a total of 240mg daily with the following 3 schedules:

• 5 days on, 2 days off
• 6 days on, 1 day off
• Continuous daily dosing

Once Daily (QD) or Twice Daily (BID) dosing, Subjects will be treated until progression of disease despite escalation/reductions of dose to the level deemed safe by available data, until intolerable/unacceptable toxicity or until subject withdrawal from the study or discontinuation of the study

Intervention Type: DRUG

Other Intervention Names

BMS-354825; Sprycel; Src Kinase

Eligibility Criteria

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 1)
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Bristol-Myers Squibb

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Other Identifiers

CA180-039

Identifier Type: -

Identifier Source: org_study_id