Multiple Ascending Dose Study of BMS-907351 (XL184) in Patients With Solid Tumors in Japan

Neoplasms Clinical Trial

Official title:

Phase 1 Multiple Ascending Dose Study of BMS-907351 (XL184) Monotherapy in Japanese Subjects With Advanced or Metastatic Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01018745
• Other study ID #: CA205-001
• Status: Completed
• Phase: Phase 1
• First received: November 24, 2009
• Last updated: January 6, 2011
• Start date: January 2010
• Est. completion date: July 2010

Study information

• Verified date: June 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 (MTD) and recommended Phase 2 dose (or dose range as appropriate) of BMS-907351 (XL184) when administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• 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 0-2

Exclusion Criteria:

• Subject has uncontrolled intercurrent illness

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-907351 (XL184)
Capsules, Oral, 25, 50, 75, 100, 125 and 175 mg, Once daily, Until disease progression or unacceptable toxicity became apparent

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 establish the MTD and recommended Phase 2 dose (or dose range as appropriate) of BMS-907351 (XL184) when administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors		Within the first 28 days	Yes
Secondary	To assess the safety and tolerability of multiple doses of BMS-907351 (XL184) administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors		Day 1, 2, 5, 8, 15, 19, 20, 29 and every 2 weeks thereafter	Yes
Secondary	To assess plasma pharmacokinetics (PK) of oral administration of BMS-907351 (XL184) and the metabolite(s) in subjects with advanced or metastatic solid tumors		Day 1, 5, 15, 19 and 29	No
Secondary	To assess tumor response (preliminary anti-tumor activity) after repeated administration of BMS-907351 (XL184)		Every 8 weeks	No
Secondary	To assess the pharmacodynamic correlates of BMS-907351 (XL184) activity		Day 1, 5, 15, 19, 29 and every 4 weeks thereafter	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