A Phase 1 interventional study of BMS-754807 in Neoplasms, sponsored by Bristol-Myers Squibb. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2011-11-30.
Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment
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.
Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: BMS-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
To determine the Maximum Tolerated Dose of BMS-754807 based on the Dose Limited Toxicity which observed during the first 28 days
Time frame: Within the first 28 days
To assess the safety and tolerability
Time frame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks
To establish recommended Phase 2 dose of BMS-754807 when administered orally on a once daily schedule
Time frame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks
To assess the metabolic effect on blood glucose
Time frame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks
To assess the pharmacokinetics of BMS-754807 administered orally on a once daily schedule
Time frame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks
To assess any preliminary evidence of anti-tumor activity
Time frame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks
To explore potential biomarkers of biological response
Time frame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks
This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.
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Bristol-Myers Squibb