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
  Purpose

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


Condition Intervention Phase
Advanced Solid Tumors
Metastatic Solid Tumors
Drug: BMS-754807
Drug: Paclitaxel
Drug: Carboplatin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Multiple Ascending Dose Study of BMS-754807 in Combination With Paclitaxel and Carboplatin in Subjects With Advanced or Metastatic Solid Tumors

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 21
Study Start Date: April 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequential allocation of patients in two dosing schedules 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00793897

Locations
Australia, Victoria
Local Institution
East Melbourne, Victoria, Australia, 3002
Local Institution
Parville, Victoria, Australia, 3050
Canada, Alberta
Local Institution
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Local Institution
Hamilton, Ontario, Canada, L8V 5C2
Korea, Republic of
Local Institution
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00793897     History of Changes
Other Study ID Numbers: CA191-005
Study First Received: November 17, 2008
Last Updated: July 12, 2012
Health Authority: Canada: Health Canada
Korea: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Bristol-Myers Squibb:
Subjects with Advanced or Metastatic Solid Tumors or Neoplasms

Additional relevant MeSH terms:
Neoplasms
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014