Chronic Myelogenous Leukemia or Philadelphia Chromosome PositiveAcute Lymphoblastic Leukemic Subjects who were previously enrolledand treated with dasatinib or imatinib in the START or CA180039protocols who are experiencing clinical benefit. The primary objective isto determine the long term safety and tolerability of treatment withdasatinib

• Conditions: Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Subjects.; MedDRA version: 14.1Level: LLTClassification code 10034877Term: Philadelphia chromosome positiveSystem Organ Class: 10022891 - Investigations; MedDRA version: 14.1Level: LLTClassification code 10009012Term: Chronic myelogenous leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2007-003624-37-GB
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-15
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 313

Inclusion Criteria

1) Signed Written Informed Consent
2) Target Population (consistent with prior CA180039 and START protocols)
a) Treatment on protocols CA180005, CA180006, CA180013, CA180015,
CA180017, or CA180039.
b) Receiving clinical benefit with dasatinib or imatinib (study CA180017) in the
opinion of the Investigator.
3) 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Sex and Reproductive Status
a) 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.
b) WOCBP using a prohibited contraceptive method (Not applicable for this study).
c) Women who are pregnant or breastfeeding
d) Women with a positive pregnancy test on enrollment or prior to investigational
product administration.
e) 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.
2) Medical History and Concurrent Diseases
a) A serious uncontrolled medical disorder or active infection that would impair the
ability of the subject to receive protocol therapy
b) Dementia or altered mental status that would prohibit the understanding or
rendering of informed consent
3) Prohibited Treatments and/or Therapies
a) 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
* chloropromazine, haloperidol, mesoridazine, thioridazine, pimozide, zyprasidone
* cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone,
halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
b) Subjects taking medications known to be potent CYP3A4 inhibitors
(i.e.ketoconazole, ritonavir) or inducers (i.e., rifampin, efavirenz).
4) Other Exclusion Criteria
a) Prisoners or subjects who are involuntarily incarcerated
b) Subjects who are compulsorily detained for treatment of either a psychiatric or
physical (eg, infectious disease) illness

Eligibility criteria for this study have been carefully considered to ensure the safety of the study subjects and to ensure that the results of the study can be used. It is imperative that subjects fully meet all eligibility criteria.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified