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

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen

Criteria

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 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.