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A Phase I Multiple Ascending Dose Study of BMS-754807 in Combination With Paclitaxel and Carboplatin in Subjects With Advanced or Metastatic Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors, Metastatic Solid Tumors

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Trial Information

A Phase I Multiple Ascending Dose Study of BMS-754807 in Combination With Paclitaxel and Carboplatin in Subjects With Advanced or Metastatic Solid Tumors


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety: Toxicities will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3

Outcome 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

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

Canada: Health Canada

Study ID:

CA191-005

NCT ID:

NCT00793897

Start Date:

April 2009

Completion Date:

June 2012

Related Keywords:

  • Advanced Solid Tumors
  • Metastatic Solid Tumors
  • Subjects with Advanced or Metastatic Solid Tumors or Neoplasms
  • Neoplasms

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