Status:

COMPLETED

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

Lead Sponsor:

Bristol-Myers Squibb

Conditions:

Advanced Solid Tumors

Metastatic Solid Tumors

Eligibility:

All Genders

18+ years

Phase:

PHASE1

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 carbopl...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2012

Estimated Enrollment :

21 Patients enrolled

Trial Details

Trial ID

NCT00793897

Start Date

April 1 2009

End Date

June 1 2012

Last Update

July 13 2012

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Local Institution

East Melbourne, Victoria, Australia, 3002

2

Local Institution

Parville, Victoria, Australia, 3050

3

Local Institution

Edmonton, Alberta, Canada, T6G 1Z2

4

Local Institution

Hamilton, Ontario, Canada, L8V 5C2