Advanced Solid Tumors
Conditions
Brief summary
Safety and Tolerability of BIIB028
Interventions
DRUGBIIB028
IV infusion administered twice weekly until disease progression or unacceptable toxicity
Sponsors
Biogen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations. * Age greater than or equal to 18 years at the time of informed consent. * Subjects with histological or cytological confirmed solid tumors who have failed standard therapies or for which no standard therapy is available. * Anticipated survival of at least 3 months in the opinion of the Investigator. * ECOG performance status of less than or equal to 2. * Lab values consistent with adequate renal hepatic and bone marrow function. * Must utilize effective contraception.
Exclusion criteria
* Pregnant (positive pregnancy test) or nursing women * Prior treatment with Hsp90 inhibitors at any time. * Prior antitumor therapies including prior experimental agents, approved antitumor small molecules and biologics, or radiotherapy with in 28 days or \<3 half lives (whichever is longer). In addition,prior to enrollment, all asociated toxicities must have been resolved to eligibility levels. * Concurrent severe or uncontrolled other medical disease (i.e, diabetes, hypertension, coronary artery disease, congestive heart failure), which in the opinion of the Investigator and/ or the Sponsor could compromise assessment of safety. * Use of anticoagulants, except low dose warfarin. * History of seizure, previous significant head trauma (e.g., associated with loss of consciousness for more than 5 minutes), abrupt discontinuation of benzodiazepines, or use of potentially epileptogenic medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability of BIIB028 | As specified in Protocol |
Secondary
| Measure | Time frame |
|---|---|
| PK and PD of BIIB028 | As specified in protocol |
| Antitumor activity | As specified in protocol |
Countries
United States
Outcome results
None listed