START Rollover Study - Full Text View

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00982488

Purpose

Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Subjects who were previously enrolled and treated with dasatinib or imatinib in the START or CA180039 protocols who are experiencing clinical benefit. The primary objective is to determine the long term safety and tolerability of treatment with dasatinib

Condition	Intervention	Phase
Leukemia	Drug: Dasatinib Drug: Imatinib	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Dasatinib in Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Subjects Who Are Experiencing Clinical Benefit on Current START or CA180-039 Protocols: Long Term Safety and Efficacy Analysis

Resource links provided by NLM:

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Imatinib Imatinib mesylate Dasatinib

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

To determine long term safety and tolerability with Dasatinib [ Time Frame: Efficacy/ Safety and tolerability data assessed every 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	288
Study Start Date:	October 2007
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Dasatinib Dependent upon previous dosing from START or CA180-039 trials	Drug: Dasatinib Tablets, Oral, 20mg BID/40mg QD to maximum 100 mg BID/180 mg QD to achieve maximum clinical benefit QD or BID dosing Subjects will be treated until progression of disease despite escalation of dose to the highest level deemed safe by available data, until intolerable/unacceptable toxicity or until subject withdrawal from the study or discontinuation of the study
Imatinib Dependent upon previous dosing from START or CA180-039 trials	Drug: Imatinib Tablets, Oral, 300 or 400 mg, BID, Subjects will be treated until disease progression, intolerable/unacceptable toxicity or until the subject withdrawal from the study or discontinuation of the study

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Signed Written Informed Consent
Target Population (consistent with prior CA180039 and START protocols)
- Treatment on protocols CA180-005, CA180-006, CA180-013, CA180-015 or CA180-017, or CA180-039
- Receiving clinical benefit with dasatinib or imatinib (study CA180017) in the opinion of the Investigator
Age and Sex
Men and women, ages 18 and older may participate
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 (4 weeks) before and at least 3 months (12 weeks) after the last dose of investigational product in such a manner that risk of pregnancy is minimized

Exclusion Criteria:

Sex and Reproductive Status
WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least one month (4 weeks) before and for at least 3 months (12 weeks) after the last dose of study medication
Women who are pregnant or breastfeeding
Women with a positive pregnancy test on enrollment or prior to investigational product administration
Sexually active fertile men whose sexual partner(s) are WOCBP, who are unwilling or unable to use an effective method to avoid pregnancy for the entire study period and for at least 3 months (12 weeks) after completion of study medication
Medical History and Concurrent Diseases
- A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
- Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
Prohibited Treatments and/or Therapies
- Subjects currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes including, but not limited to:
  - quinidine, procainamide, disopyramide
  - amiodarone, sotalol, ibutilide, dofetilide
  - erythromycins, clarithromycin
  - chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, ziprasidone
  - cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
- Subjects taking medications known to be potent CYP3A4 inhibitors (i.e., ketoconazole, ritonavir) or inducers (i.e., rifampin, efavirenz)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00982488

Show 54 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA180-188, 2007-003624-37
Study First Received:	September 16, 2009
Last Updated:	February 3, 2010
ClinicalTrials.gov Identifier:	NCT00982488 History of Changes
Health Authority:	United States: Food and Drug Administration; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Canada: Regulatory Affairs Division Office of Clinical Trials Therapeutic Products Directorate; Germany: Federal Institute for Drugs and Medical Devices; Germany: Ministry of Health; Peru: Insitucion Nacional de Salud (INS); Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Switzerland: Federal Office of Public Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Brazil: ANVISA (Agencia Nacional de Vigilancia), CONEP ( Commission National Ethical Research) (National Central IRB); Korea: Food and Drug Administration; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Finland: National Agency for Medicines, Data Protection Board, the National Advisory Board on Health Care Ethics; Poland: National Institute of Medicines, Ministry of Health, Office for Registration of Medicinal Products, Medical Devices, and biomedical Products; Ireland: Irish Medicines Board; South Africa: Medicines Control Council (MCC); Germany: Federal Institute for Drugs and Medicinal Devices, Ministry of Health; Thailand: Food and Drug Administration, Ministry of Public Health; Russia: Committee on Ethics under Federal Supervision Service for Public Health and Social Affairs

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Hematologic Diseases
Myeloproliferative Disorders
Enzyme Inhibitors
Leukemia, Myeloid
Protein Kinase Inhibitors

Pharmacologic Actions
Leukemia
Neoplasms
Dasatinib
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Bone Marrow Diseases

ClinicalTrials.gov processed this record on February 08, 2010