Status:
COMPLETED
Study of Dasatinib (BMS-354825) in Patients With Solid Tumors
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Tumors
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00339144
Start Date
January 1 2007
End Date
September 1 2008
Last Update
December 15 2010
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Local Institution
Sayama, Osaka, Japan, 589-0014
2
Local Institution
Koto-Ku, Tokyo, Japan, 135-0063