This is a Phase 1 dose escalation study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of BMS-754807 in patients with advanced or metastatic solid tumors. In addition, the study is expected to identify the recommended dose or dose range of BMS-754807 for Phase 2 studies
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Tablets, Oral, Dose Cohorts: 4mg, 10mg, 20mg, 30mg, 50mg, 70mg, 100mg, 130mg, 160mg, 200mg, Once Daily, Until disease progression, unacceptable toxicity or at the subject's request
Local Institution
East Melbourne, Victoria, Australia
Local Institution
Footscray, Victoria, Australia
Local Institution
Heidelberg, Victoria, Australia
Local Institution
Parkville, Victoria, Australia
Safety - Toxicities will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3
Time frame: Continuous assessment throughout the duration of the trial
Pharmacokinetics
Time frame: assessed during the first 4 weeks of the study
Pharmacodynamics
Time frame: assessed during the first 4 weeks of the study
Metabolic measures
Time frame: assessed during the first 4 weeks of the study
ECG
Time frame: assessed during the first 4 weeks of the study
Efficacy Measures
Time frame: assessed every 8 weeks
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Local Institution
Nedlands, Western Australia, Australia