Neoplasms
Conditions
Brief summary
The purpose of this clinical study is to establish the maximum tolerated dose of BMS-754807 when administered orally on a once daily schedule in subjects with solid tumors.
Interventions
DRUGBMS-754807
Tablets, Oral, 20 mg, 30 mg, 50 mg, 70 mg, 100 mg, 130 mg, 160 mg, 200 mg once daily, 3-5 months, depending on response
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate * Life expectancy of at least 3 months * Eastern Cooperative Oncology Group performance 0-1
Exclusion criteria
* Any disorder with dysregulation of glucose homeostasis * Dumping syndrome * History of glucose intolerance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the Maximum Tolerated Dose of BMS-754807 based on the Dose Limited Toxicity which observed during the first 28 days | Within the first 28 days |
Secondary
| Measure | Time frame |
|---|---|
| To establish recommended Phase 2 dose of BMS-754807 when administered orally on a once daily schedule | Day 1, 8, 15, 22, 29, thereafter every 2 weeks |
| To assess the metabolic effect on blood glucose | Day 1, 8, 15, 22, 29, thereafter every 2 weeks |
| To assess the safety and tolerability | Day 1, 8, 15, 22, 29, thereafter every 2 weeks |
| To assess any preliminary evidence of anti-tumor activity | Day 1, 8, 15, 22, 29, thereafter every 2 weeks |
| To explore potential biomarkers of biological response | Day 1, 8, 15, 22, 29, thereafter every 2 weeks |
| To assess the pharmacokinetics of BMS-754807 administered orally on a once daily schedule | Day 1, 8, 15, 22, 29, thereafter every 2 weeks |
Countries
Japan
Outcome results
None listed