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Study of Dasatinib (BMS-354825) in Patients With Solid Tumors

NCT ID: NCT00339144

Last Updated: 2010-12-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-09-30

Brief Summary

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The primary objective of this study is to determine the maximum tolerated dose (MTD) or the maximum administered dose (MAD) of Dasatinib (BMS-354825) in patients in Japan.

Detailed Description

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Conditions

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Tumors

Keywords

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Solid tumors (including relapsed disease) that are refractory to standard therapies or for which no effective standard therapy exists

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dasatinib (100 mg)

Group Type EXPERIMENTAL

Dasatinib

Intervention Type DRUG

tablets, Oral, 100 mg, once daily for 4 weeks

Dasatinib (150 mg)

Group Type EXPERIMENTAL

Dasatinib

Intervention Type DRUG

tablets, Oral, 150 mg, once daily, 4 weeks

Dasatinib (200 mg)

Group Type EXPERIMENTAL

Dasatinib

Intervention Type DRUG

tablets, Oral, 200 mg, once daily for 4 weeks

Interventions

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Dasatinib

tablets, Oral, 100 mg, once daily for 4 weeks

Intervention Type DRUG

Dasatinib

tablets, Oral, 150 mg, once daily, 4 weeks

Intervention Type DRUG

Dasatinib

tablets, Oral, 200 mg, once daily for 4 weeks

Intervention Type DRUG

Other Intervention Names

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Sprycel BMS-354825 Sprycel BMS-354825 Sprycel BMS-354825

Eligibility Criteria

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Inclusion Criteria

* Performance status (general conditions) specified by the Eastern Cooperative Oncology Group: 0-2
* Histologic or cytologic diagnosis of a solid tumor which has progressed on or following standard therapies (including relapsed disease) or for which no standard therapy exists.
* men and women, ages 20 and over
* women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 3 months after the study in such a manner that the risk of pregnancy is minimized
* Adequate hepatic function

Exclusion Criteria

* Participants who are eligible and willing to undergo transplantation at pre- study.
* Women who are pregnant or breastfeeding with known brain metastasis or symptoms of brain metastasis
* Uncontrolled or significant bleeding disorder unrelated to a primary tumor
* Dementia or mental illness that would prohibit understanding or giving informed consent.
* Severe allergy to drugs required for appropriate supportive care of patients in this study.
* History of gastrointestinal surgery or of any digestive disorder which has the potential to inhibit absorption of the study drug.
* Pleural effusion \> Grade 1
* Patient with dysphagia
* Does not agree to blood/blood products transfusion(s)
* Donated blood over 200 mL within 4 weeks prior to the start of study therapy
* Medication that known to have a risk of causing Torsade de pointes
* Participants who are compulsorily detained for legal reasons or treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Sayama, Osaka, Japan

Site Status

Local Institution

Koto-Ku, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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CA180-058

Identifier Type: -

Identifier Source: org_study_id