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

Completed · Phase 1

Conditions studied: Solid Tumors

In brief

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

Key facts

Study ID

NCT00674947

Run by

Biogen

People needed

55

Starts

2008-06-01

Expected to finish

2011-06-01

Last updated by the study team

2013-09-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Santa Monica, California, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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