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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Neoplasms; Metastases; Solid Tumors

Treatments: Drug: BMS-754807

Study type: Interventional

Funder types: Industry

Identifiers

NCT00569036

CA191-002

Details and patient eligibility

About

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

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 1 patient group

BMS-754807

Experimental group

Description:

Single arm, multiple-ascending dose escalation study

Treatment:

Drug: BMS-754807