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

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 1

Conditions

Tumors

Treatments

Drug: Dasatinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00339144

CA180-058

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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