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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00866736
Other study ID # KCSG-01
Secondary ID
Status Completed
Phase Phase 2
First received March 18, 2009
Last updated September 14, 2015
Start date March 2009
Est. completion date June 2012

Study information

Verified date December 2010
Source Kanto CML Study Group
Contact n/a
Is FDA regulated No
Health authority Japan: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and the safety of dasatinib in subject with chronic phase chronic myeloid leukemia(CML) who are either resistant to or intolerant of imatinib mesylate.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 15 Years and older
Eligibility Inclusion Criteria:

- Signed Written Informed Consent

- Subjects with chronic phase chronic myeloid leukemia (CML)

- Subjects resistant/intolerant to imatinib

- Subjects presenting:

1. ECOG performance status (PS) score 0-2

2. Adequate hepatic function

3. Adequate renal function

4. Adequate lung function

Exclusion Criteria:

- Concurrent malignancy other than CML

- Women who are pregnant or breastfeeding

- Concurrent pleural effusion

- Uncontrolled or significant cardiovascular disease

- A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy.

- Prior therapy with dasatinib

- Subjects with T315I and/or F317L BCR-ABL point mutations

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
dasatinib
100mg QD

Locations

Country Name City State
Japan Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital Bunkyo-ku Tokyo

Sponsors (2)

Lead Sponsor Collaborator
Kanto CML Study Group Epidemiological and Clinical Research Information Network

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary rate of Major Molecular Responses (MMR) in chronic phase chronic myeloid leukemia subjects at 12 months No
Secondary safety after treatment with dasatinib 2 year Yes
Secondary rate of Complete Cytogenetic Response(CCyR) 2 year No
Secondary rate of Complete Hematologic Response (CHR) 2 year No
Secondary efficacy on patients with BCR-ABL point mutations 2 year No
Secondary progression free survival 2 year No
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