NCT00569036

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Neoplasms
• Solid Tumors
• Metastases

Interventions

Type	Name	Description
DRUG	BMS-754807	Tablets, Oral, Dose Cohorts: 4mg, 10mg, 20mg, 30mg, 50mg, 70mg, 100mg, 130mg, 160mg, 200mg, Once Daily, Until disease progression, unacceptable toxicity or at the subject's request

Timeline

• Start date: 2008-04-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2007-12-06
• Last updated: 2013-08-14

Locations

5 sites across 1 country: Australia