Multiple Dose Study In Cancer Patients: Safety and Tolerability of BMS-754807 in Combination With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00793897
First received: November 17, 2008
Last updated: July 12, 2012
Last verified: July 2012

November 17, 2008
July 12, 2012
April 2009
June 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00793897 on ClinicalTrials.gov Archive Site
  • Pharmacodynamics: Biochemical parameters of drug action in serum [ Time Frame: assessed every 6 weeks of the study ] [ Designated as safety issue: No ]
  • Metabolic measures: Effects of the drug on parameters of glucose homeostasis [ Time Frame: assessed every 6 weeks of the study ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Pharmacodynamics: Biochemical parameters of drug action in serum [ Time Frame: assessed every 6 weeks of the study ] [ Designated as safety issue: No ]
  • Metabolic measures: Effects of the drug on parameters of glucose homeostasis [ Time Frame: assessed every 6 weeks of the study ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Multiple Dose Study In Cancer Patients: Safety and Tolerability of BMS-754807 in Combination With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Solid Tumors
A Phase I Multiple Ascending Dose Study of BMS-754807 in Combination With Paclitaxel and Carboplatin in Subjects With Advanced or Metastatic Solid Tumors

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Advanced Solid Tumors
  • Metastatic Solid Tumors
  • Drug: BMS-754807
    Tablets, Oral, escalating doses starting at 10 mg, continuous or intermittent, until disease progression, unacceptable toxicity or at the subject's request
    Other Name: IGF-IR
  • Drug: Paclitaxel
    Vials, IV, 200 mg/m2, Day 1 of a 21-day cycle, until disease progression, unacceptable toxicity or at the subject's request
    Other Names:
    • Taxol
    • BMS-181339
  • Drug: Carboplatin
    Vials, IV, 6 mg/mL.min, Day 1 of a 21-day cycle, until disease progression, unacceptable toxicity or at the subject's request
    Other Names:
    • Paraplatin
    • BMY-26575
Experimental: Sequential allocation of patients in two dosing schedules
Interventions:
  • Drug: BMS-754807
  • Drug: Paclitaxel
  • Drug: Carboplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   Korea, Republic of
 
NCT00793897
CA191-005
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP