A Study of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors

Solid Tumors Clinical Trial

Official title:

Phase I Multiple Ascending Dose Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Japanese Patients With Advanced or Metastatic Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00390936
• Other study ID #: CA182-012
• Status: Completed
• Phase: Phase 1
• First received: October 20, 2006
• Last updated: January 24, 2011
• Start date: October 2007
• Est. completion date: March 2010

Study information

• Verified date: March 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 study is to assess the dose limiting toxicity (DLT) of BMS-582664 and the maximum tolerated dose(MTD) in subjects with advanced or metastatic solid tumors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients must have measurable disease

• Documented failure to standard therapies exist, or which are determined to be inappropriate by the investigator

• ECOG PS: 0-1

Exclusion Criteria:

• Subjects with centrally located squamous cell carcinoma of the lung

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• Brivanib
Tablet, Oral, Brivanib 300 mg, 600 mg, 800 mg, 1000 mg, once daily (cycle 1: Day 1, Day 8 - 35), more than 5 weeks depending on response/toxicity

Locations

Country	Name	City	State
Japan	Local Institution	Sunto-Gun	Shizuoka

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limiting Toxicity		at the end of the first cycle of the study	Yes
Primary	Maximum Tolerated Dose		at the end of the first cycle of the study	Yes
Secondary	To assess any preliminary evidence of anti-tumor activity observed with BMS-582664		at the end of the study	No

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