Multiple Ascending Dose Study of BMS-754807 in Patients With Solid Tumors in Japan

Phase 1 Multiple Ascending Dose Study of BMS-754807 in Patients With Solid Tumors in Japan

The purpose of this clinical study is to establish the maximum tolerated dose of BMS-754807 when administered orally on a once daily schedule in subjects with solid tumors.

Study Overview

• Status: Completed
• Conditions: Neoplasms
• Intervention / Treatment: Drug: BMS-754807

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Chuo-Ku, Tokyo, Japan, 104-0045
      • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate
• Life expectancy of at least 3 months
• Eastern Cooperative Oncology Group performance 0-1

Exclusion Criteria:

• Any disorder with dysregulation of glucose homeostasis
• Dumping syndrome
• History of glucose intolerance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BMS-754807	Drug: BMS-754807; Tablets, Oral, 20 mg, 30 mg, 50 mg, 70 mg, 100 mg, 130 mg, 160 mg, 200 mg once daily, 3-5 months, depending on response

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the Maximum Tolerated Dose of BMS-754807 based on the Dose Limited Toxicity which observed during the first 28 days	Within the first 28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess the safety and tolerability	Day 1, 8, 15, 22, 29, thereafter every 2 weeks
To establish recommended Phase 2 dose of BMS-754807 when administered orally on a once daily schedule	Day 1, 8, 15, 22, 29, thereafter every 2 weeks
To assess the metabolic effect on blood glucose	Day 1, 8, 15, 22, 29, thereafter every 2 weeks
To assess the pharmacokinetics of BMS-754807 administered orally on a once daily schedule	Day 1, 8, 15, 22, 29, thereafter every 2 weeks
To assess any preliminary evidence of anti-tumor activity	Day 1, 8, 15, 22, 29, thereafter every 2 weeks
To explore potential biomarkers of biological response	Day 1, 8, 15, 22, 29, thereafter every 2 weeks

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: May 11, 2009
• First Submitted That Met QC Criteria: May 11, 2009
• First Posted (Estimate): May 12, 2009

Study Record Updates

• Last Update Posted (Estimate): November 30, 2011
• Last Update Submitted That Met QC Criteria: November 29, 2011
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: CA191-003