A Study of Dasatinib in Patients With Imatinib Resistant... | NCT00866736

Studies
A Study of Dasatinib in Patients With Imatinib Resistant or Intolerant Chronic Myeloid Leukemia

NCT00866736

Sponsor

Kanto CML Study Group

Status

Completed

Last Update Posted

Sep 15, 2015Estimated

Enrollment

65Actual

Phase

Phase 2

Conditions

Chronic Myeloid Leukemia

Interventions

dasatinib

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Mar 18, 2009

First Submission Date that Met QC Criteria

Mar 19, 2009

First Posted Date

Mar 20, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2015

Last Update Posted Date

Sep 15, 2015Estimated

Name	Class
Epidemiological and Clinical Research Information Network	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

65Actual

Label	Type	Description	Intervention Names
dasatinib	Experimental		Drug: dasatinib

Name	Type	Description	Arm Group Labels	Other Names
dasatinib	Drug	100mg QD	dasatinib	BMS-354825

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
rate of Major Molecular Responses (MMR) in chronic phase chronic myeloid leukemia subjects		at 12 months

Secondary Outcomes

Measure	Description	Time Frame
safety after treatment with dasatinib		2 year
rate of Complete Cytogenetic Response(CCyR)		2 year
rate of Complete Hematologic Response (CHR)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hisashi Sakamaki, MD.PhD	Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital		Bunkyo-ku	Tokyo	113-8677	Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25501110	Derived	Inokuchi K, Kumagai T, Matsuki E, Ohashi K, Shinagawa A, Hatta Y, Takeuchi J, Yoshida C, Wakita H, Kozai Y, Shirasugi Y, Fujisawa S, Iwase O, Yano S, Okamoto S, Oba K, Sakamoto J, Sakamaki H. Efficacy of molecular response at 1 or 3 months after the initiation of dasatinib treatment can predict an improved response to dasatinib in imatinib-resistant or imatinib-intolerant Japanese patients with chronic myelogenous leukemia during the chronic phase. J Clin Exp Hematop. 2014;54(3):197-204. doi: 10.3960/jslrt.54.197.

ID	Term
D015464	Leukemia, Myelogenous, Chronic, BCR-ABL Positive
D015466	Leukemia, Myeloid, Chronic-Phase

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

ID	Term
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D001393	Azoles