Status:
COMPLETED
A Phase I Study of BIIB015 in Relapsed/Refractory Solid Tumors
Lead Sponsor:
Biogen
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Phase 1, open-labeled, safety and tolerability study for the treatment of subjects with relapsed or refractory solid tumors.
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age 18 years or older at the time of informed consent.
- Solid tumors that are relapsed or refractory to at least 1 prior anti-cancer systemic therapy and for which no standard therapy exists.
- ECOG Performance Status \</= 2.
- Exclusion Criteria
- History of keratoconjunctivitis, open or closed angle glaucoma, or "dry eye" disease.
- New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- History of myocardial infarction within 6 months prior to Day 1.
- Presence of \>/= Grade 2 peripheral neuropathy.
- Known presence of central nervous system or brain metastases.
- Prior therapy with a conjugated or unconjugated maytansine derivative.
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00674947
Start Date
June 1 2008
End Date
June 1 2011
Last Update
September 16 2013
Active Locations (3)
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1
Research Site
Santa Monica, California, United States
2
Research Site
Philadelphia, Pennsylvania, United States
3
Research Site
San Antonio, Texas, United States