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A Phase II Study to Determine the Activity of Dasatinib Administered Orally (PO) at a Dose of 100 mg Once Daily (QD) in Chronic Phase Chronic Myelogenous Leukemia (CML), at a Dose of 70 mg Twice Daily (BID) in Advanced Phase Chronic Myelogenous Leukemia (CML) Chinese Subjects Who Are Resistant to or Intolerant of Imatinib Mesylate (GleevecĀ®)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Leukemia

Thank you

Trial Information

A Phase II Study to Determine the Activity of Dasatinib Administered Orally (PO) at a Dose of 100 mg Once Daily (QD) in Chronic Phase Chronic Myelogenous Leukemia (CML), at a Dose of 70 mg Twice Daily (BID) in Advanced Phase Chronic Myelogenous Leukemia (CML) Chinese Subjects Who Are Resistant to or Intolerant of Imatinib Mesylate (GleevecĀ®)


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants With Major Cytogenetic Response (MCyR)

Outcome Description:

Major Cytogenetic Response (MCyR) is defined as Complete Cytogenetic Response (CCyR: 0% Ph-chromosome-positive cells in metaphase in bone marrow [BM]) or Partial Cytogenetic Response (PCyR: 1-35% Ph-chromosome-positive cells in metaphase in [BM]).

Outcome Time Frame:

12 months of follow-up from the start of dasatinib treatment (data cut-off date: 18-Jun-2010)

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

China: Food and Drug Administration

Study ID:

CA180-160

NCT ID:

NCT00529763

Start Date:

December 2003

Completion Date:

December 2012

Related Keywords:

  • Leukemia
  • Chronic Phase, Advanced Phase chronic myeloid leukemia
  • Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid, Chronic-Phase

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