Metastases, Neoplasms, Solid Tumors
Conditions
Keywords
Advanced or Metastatic Solid Tumors or Neoplasms
Brief summary
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
Interventions
DRUGBMS-754807
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
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate * ECOG performance status 0-1 * at least 4 weeks between surgery or last dose prior anti-cancer therapy
Exclusion criteria
* symptomatic brain metastases * any disorder or dysregulation of glucose homeostasis {e.g. diabetes) * uncontrolled or significant cardiovascular disease * inadequate bone marrow, liver or kidney function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety - Toxicities will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3 | Continuous assessment throughout the duration of the trial |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | assessed during the first 4 weeks of the study |
| Pharmacodynamics | assessed during the first 4 weeks of the study |
| Metabolic measures | assessed during the first 4 weeks of the study |
| ECG | assessed during the first 4 weeks of the study |
| Efficacy Measures | assessed every 8 weeks |
Countries
Australia
Outcome results
None listed