Once or Twice Daily Administration of BIIB021 to Subjects With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to see if daily and twice daily administration of BIIB021 is tolerated in patients with advanced solid tumors.

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

Details

• Lead Sponsor: Biogen

Criteria

Inclusion Criteria:

Subjects with histologically or cytologically confirmed solid tumor who have failed or refused standard therapies or for which no approved therapy is available.

Age greater than or equal to 18 years at the time of informed consent. ECOG performance status of less than or equal to 2. Lab values consistent with adequate renal, hepatic, and bone marrow functions.

Exclusion Criteria:

Prior antitumor therapies, including prior experimental agents or approved antitumor small molecules and biologics within 28 days and all associated toxicities resolved to eligibility levels.

Subjects with known brain metastases. Concurrent severe or uncontrolled medical disease. Must utilize effective contraception.