A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of BIIB021 Administered Once or Twice Daily to Subjects With Advanced Solid Tumors
18 Years
N/A
Both
Advanced Solid Tumors
Trial Information
A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of BIIB021 Administered Once or Twice Daily to Subjects With Advanced Solid Tumors
Heat shock protein 90 (HSP90) inhibitors are anticipated to have clinical activity in solid
tumors because Hsp90 is required for the folding, activation, and assembly of many proteins
involved in cancer cell survival, proliferation, and metastasis. The maximum tolerated dose
(MTX) for BIIB021 administered twice weekly in a phase I study in subjects with advanced
solid tumors have been defined at 600mg. It is now reasonable from a safety perspective and
desirable from a pharmacokinetic perspective to evaluate more frequent dosing intervals in
solid tumors with the goal of providing more sustained and completed inhibition of Hsp90.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety and tolerability of BIIB021
Outcome Time Frame:
As specified in protocol
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
120ST103
NCT ID:
NCT00618735
Start Date:
February 2008
Completion Date:
December 2010
Related Keywords:
- Advanced Solid Tumors
- Neoplasms
Name | Location |
|---|---|
| Research Site | Anaheim, California |
| Research Site | Abilene, Texas |
