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

Biogen

Status and phase: Completed; Phase 1

Conditions: Solid Tumors

Treatments: Drug: BIIB015

Study type: Interventional

Funder types: Industry

Identifiers

NCT00674947

207ST101

Details and patient eligibility

About

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

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 </= 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)