BMS-599626 in Patients With Advanced Solid Malignancies
Phase 1
Completed
- Conditions
- CancerMetastases
- Interventions
- Drug: panHer
- Registration Number
- NCT00095537
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this trial is to identify the highest oral dose of BMS-599626, a drug that is directed against EGFR and HER2 proteins, that can be given safely on a daily schedule of 21 days with a 7 day rest period in patients with cancer who no longer benefit from other commonly used treatments. The study will also test for other proteins that may be affected by BMS-599626; and the level of study drug in the blood will be studied.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Diagnosis of metastatic cancer that has progressed on currently available therapies;
- At least 3 month life expectancy;
- Primary cancer must be solid (non-hematologic);
- Adequate bone marrow, liver & kidney function;
- Negative pregnancy test.
Exclusion Criteria
- Serious, uncontrolled medical disorder;
- Individuals not willing or able to use an acceptable method to avoid pregnancy for the entire study period and for at least 3 months after the study;
- Pregnant or breastfeeding women;
- Patients with known brain metastasis;
- Uncontrolled or significant cardiovascular disease;
- Anticancer therapy within 2-6 weeks prior to study drug (depending on the therapy)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Phase 1 MTD Study panHer -
- Primary Outcome Measures
Name Time Method Det. the max tolerated dose,biologically active doses & recommended phase 2 dose of BMS-599626 when adm. as a daily oral dose to pts with HER2 expressing-metastatic solid tumors who have progressed on or following standard therapy
- Secondary Outcome Measures
Name Time Method Evaluate the effect of BMS-599626 on biomarkers & predictive markers of HER1/2 in skin metabolic act. through PET imaging & preliminary evidence of anti-tumor act.,determine the effect of gastric acid modifying agents on systemic exposure of BMS-599626
Trial Locations
- Locations (1)
Local Institution
🇺🇸Los Angeles, California, United States