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A Phase I Study of BMS-354825 in Patients With Solid Tumors

Phase 1
20 Years
Not Enrolling

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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

- Severe allergy to drugs required for appropriate supportive care of patients in this

- 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:


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:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


Japan: Ministry of Health, Labor and Welfare

Study ID:




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