Clinical Trial Registry
Trial Details for Trial
CA180-039
Purpose: To determine the long term safety and tolerability of dasatinib exposure in subjects
previously treated in CA180-002.
Overall Recruitment Status: Completed
Condition(s): Leukemia
Intervention(s): Dasatinib
Phase: Phase 1
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study,Intervention Model: Single Group Assignment,Masking: Open Label,Primary Purpose: Treatment
Official Title: 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
Primary Outcome Measures:
To determine long term safety and tolerability with Dasatinib
Time Frame : At 14 days of start of study, every 3 months until 2 years, every 6 months after two years , and at End of treatment
Secondary Outcome Measures:
Describe any hematologic or cytogenetic response in subjects during treatment within protocol CA180-039
Time Frame : At 14 days of start of study, every 3 months until 2 years, every 6 months after two years , and at End of treatmentDetermine the duration of hematologic and cytogenetic response on dasatinib (including time on CA180-002)
Time Frame : At 14 days of start of study, every 3 months until 2 years, every 6 months after two years , and at End of treatment
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Arms
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Assigned Interventions
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Dasatinib:Experimental
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Drug: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
QD or 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
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Actual Enrollment: 46
Study Start Date: December 2005
Actual Primary Completion Date: September 2008
Download Date: Information obtained from ClinicalTrials.gov on July 27, 2010
Link Text: Link to the current ClinicalTrials.gov record.
URL: http://clinicaltrials.gov/show/NCT00978731
Eligibility
Minimum age: 18 Years
Maximum age: N/A
Gender(s): Both
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
- ECOG performance status 0, 1, or 2 (See Appendix 1)
- Prior history of Philadelphia chromosome positive chronic, accelerated, or blast phase CML or Ph
- + ALL
Exclusion Criteria:- 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
- Women with a positive pregnancy test on enrollment or prior to study drug administration
- 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
- Pregnancy
- 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 QTc interval on pre-entry electrocardiogram ( > 450 msec)
- Uncontrolled hypertension
- Dementia or altered mental status that would prohibi t 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
- ALT and 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
General
Contact Information
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More Information
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
PhRMA website - CSR Synopsis
Health Authority : United States: Food and Drug Administration