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

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1 dose escalation study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of BMS-754807 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 for Phase 2 studies

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb

Criteria

Inclusion Criteria:

• Subjects with advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate

• 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