A Phase I Study of BIIB015 in Relapsed/Refractory Solid Tumors

Phase 1

Completed

• Conditions: Solid Tumors

• Registration Number: NCT00674947
• Lead Sponsor: Biogen

Brief Summary

Phase 1, open-labeled, safety and tolerability study for the treatment of subjects with relapsed or refractory solid tumors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-05-06
• Study First Submitted QC: 2008-05-07
• Study First Posted: 2008-05-08
• Study Start: 2008-06
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2011-09
• Last Update Submitted: 2013-09-12
• Last Update Posted: 2013-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine the maximum-tolerated dose (MTD)	ongoing
To evaluate safety	ongoing

Secondary Outcome Measures

Name	Time	Method
To evaluate clinical activity	ongoing
To evaluate pharmacokinetics (PK)	ongoing

Trial Locations

Locations (1)

Research Site; 🇺🇸 San Antonio, Texas, United States