Solid Tumors
Conditions
Keywords
Relapsed, Refractory
Brief summary
Phase 1, open-labeled, safety and tolerability study for the treatment of subjects with relapsed or refractory solid tumors.
Interventions
DRUGBIIB015
IV infusion once every 3 weeks until disease progression or unacceptable toxicity
Sponsors
Biogen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate safety | ongoing |
| To determine the maximum-tolerated dose (MTD) | ongoing |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate pharmacokinetics (PK) | ongoing |
| To evaluate clinical activity | ongoing |
Countries
United States
Outcome results
None listed