A Phase I Study of BMS-354825 in Patients With Solid Tumors
20 Years
N/A
Both
Tumors
Trial Information
A Phase I Study of BMS-354825 in Patients With Solid Tumors
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum Tolerated Dose (MTD) and Maximum Acceptable Dose (MAD) of Dasatinib as Determined by Number of Participants With Dose-Limiting Toxicities (DLTs) Related to Dasatinib Treatment
Outcome Description:
MAD: highest dose level at which >=1 DLTs were reported, MTD: dose one step lower than MAD. DLT: any of the following considered related to dasatinib during course 1:Grade 3(dose reduction by 1 dose level)/Grade 4:recurring nausea, vomiting or diarrhea; any other Grade >=3 non-hematologic toxicity except alopecia or fatigue;any grade toxicity requiring two dose reductions or participant's discontinuation; Grade 4 neutropenia <500 cells/mm^3 for >=5 consecutive days or febrile neutropenia; Grade 4 thrombocytopenia <25,000 cells/mm^3 or Grade 3 bleeding requiring platelet transfusion.
Outcome Time Frame:
From start of the treatment i.e.Day 1 to end of Cycle 1 i.e. Day 30 (4 weeks)
Safety Issue:
Yes
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
CA180-058
NCT ID:
NCT00339144
Start Date:
January 2007
Completion Date:
September 2008
Related Keywords:
- Tumors
- Solid tumors (including relapsed disease) that are refractory to standard therapies or for which no effective standard therapy exists
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