Dasatinib in Imatinib Resistant/Intolerant Chinese CML (Chronic and Advanced Phase) Subjects

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Leukemia

Treatments: Drug: Dasatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00529763

CA180-160

Details and patient eligibility

About

The primary objective of this study is to estimate the major cytogenetic response (MCyR) rate to Dasatinib in subjects with CP CML, complete and overall hematologic response (CHR and OHR) rate in subjects with AD CML or Ph+ ALL who have primary or acquired resistance to imatinib, or are intolerant of imatinib, when administered at 100 mg QD (Chronic CML) or 70mg BID (AP CML and Ph+ALL).

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Signed Written Informed Consent

• Men and women, ages 18 years of age or older

• Subjects with Chronic Phase (CP) or Advanced Disease (AD) chronic myeloid leukemia (CML)/Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)

• Subjects resistant/intolerant to imatinib

• Subjects presenting:

  1. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-2
  2. Adequate hepatic function
  3. Adequate renal function
  4. Sodium, Potassium, Magnesium, Phosphorus, Calcium higher or equal than the lower limit of normal range

Exclusion Criteria:

• Women of child bearing potential who are not using adequate birth control
• Women who are pregnant or breastfeeding
• Subjects eligible for stem cell transplantation
• Serious uncontrolled medical disorder or active infection
• Uncontrolled or significant cardiovascular disease
• Concurrent incurable malignancy other than CML
• Subjects who received imatinib, interferon, cytarabine within 7 days or other antineoplastic agents other than hydroxyurea within 14 days before dasatinib, Dasatinib in the past
• History of significant bleeding unrelated to CML

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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121 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Dasatinib