Advanced Solid Tumors, Metastatic Solid Tumors
Conditions
Keywords
Subjects with Advanced or Metastatic Solid Tumors or Neoplasms
Brief summary
A Phase I dose escalation study to determine the safety, tolerability, pharmacodynamics and preliminary anti-tumor activity of BMS-754807 in combination with chemotherapy drugs, paclitaxel and carboplatin, 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 in combination with paclitaxel and carboplatin for Phase 2 studies
Interventions
DRUGBMS-754807
Tablets, Oral, escalating doses starting at 10 mg, continuous or intermittent, until disease progression, unacceptable toxicity or at the subject's request
DRUGPaclitaxel
Vials, IV, 200 mg/m2, Day 1 of a 21-day cycle, until disease progression, unacceptable toxicity or at the subject's request
DRUGCarboplatin
Vials, IV, 6 mg/mL.min, Day 1 of a 21-day cycle, 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 carboplatin and paclitaxel is considered an appropriate therapy * 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 * Evidence of \> Grade 1 peripheral neuropathy
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: starting with dosing on Day 1 until after 30 day follow-up following the last dose |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamics: Biochemical parameters of drug action in serum | assessed every 6 weeks of the study |
| Metabolic measures: Effects of the drug on parameters of glucose homeostasis | assessed every 6 weeks of the study |
| Efficacy Measures: PET scans and tumor assessments by CT/MRI | a total of 3 PET scans at screening and during the first 3 weeks. CT/MRI assessed every 6 weeks |
| Pharmacokinetic Measures: Blood samples will be collected during pre-specified times | Day 2, 8 and 15 of Cycle 1 and on Day 1 or Cycle 2 (for Arm A subjects only) |
Countries
Australia, Canada, South Korea
Outcome results
None listed