A Phase 1 interventional study of BMS-754807 and Paclitaxel in Advanced Solid Tumors and Metastatic Solid Tumors, sponsored by Bristol-Myers Squibb. Completed at 5 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-07-13.
Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment
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
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 21 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →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.
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Exclusion Criteria:
Drug: BMS-754807 · Drug: Paclitaxel · Drug: Carboplatin
Tablets, Oral, escalating doses starting at 10 mg, continuous or intermittent, until disease progression, unacceptable toxicity or at the subject's request
Also known as: IGF-IR
Vials, IV, 200 mg/m2, Day 1 of a 21-day cycle, until disease progression, unacceptable toxicity or at the subject's request
Also known as: Taxol, BMS-181339
Vials, IV, 6 mg/mL.min, Day 1 of a 21-day cycle, until disease progression, unacceptable toxicity or at the subject's request
Also known as: Paraplatin, BMY-26575
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: starting with dosing on Day 1 until after 30 day follow-up following the last dose
Pharmacodynamics: Biochemical parameters of drug action in serum
Time frame: assessed every 6 weeks of the study
Metabolic measures: Effects of the drug on parameters of glucose homeostasis
Time frame: assessed every 6 weeks of the study
Efficacy Measures: PET scans and tumor assessments by CT/MRI
Time frame: 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
Time frame: Day 2, 8 and 15 of Cycle 1 and on Day 1 or Cycle 2 (for Arm A subjects only)
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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