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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00898716
• Other study ID #: CA191-003
• Status: Completed
• Phase: Phase 1
• First received: May 11, 2009
• Last updated: November 29, 2011
• Start date: September 2009
• Est. completion date: July 2011

Study information

• Verified date: July 2010
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

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

Locations

Country	Name	City	State
Japan	Local Institution	Chuo-Ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To assess the safety and tolerability		Day 1, 8, 15, 22, 29, thereafter every 2 weeks	Yes
Secondary	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	Yes
Secondary	To assess the metabolic effect on blood glucose		Day 1, 8, 15, 22, 29, thereafter every 2 weeks	Yes
Secondary	To assess the pharmacokinetics of BMS-754807 administered orally on a once daily schedule		Day 1, 8, 15, 22, 29, thereafter every 2 weeks	No
Secondary	To assess any preliminary evidence of anti-tumor activity		Day 1, 8, 15, 22, 29, thereafter every 2 weeks	Yes
Secondary	To explore potential biomarkers of biological response		Day 1, 8, 15, 22, 29, thereafter every 2 weeks	Yes

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form