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

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Dasatinib

Criteria

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