Once or Twice Daily Administration of BIIB021 to Subjects With Advanced Solid Tumors
The purpose of the study is to see if daily and twice daily administration of BIIB021 is tolerated in patients with advanced solid tumors.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Safety and tolerability of BIIB021 [ Time Frame: As specified in protocol ] [ Designated as safety issue: Yes ]
- PK and PD of BIIB021 [ Time Frame: As specified in protocol ] [ Designated as safety issue: No ]
- Antitumor activity [ Time Frame: As specified in protocol ] [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Study Completion Date:||December 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Subjects in Schedule A will take BIIB021 in the morning at approximately 0800 with at least 6 ounces of water following an overnight fast (Beginning at midnight).
Dosage, frequency (once daily), and duration as specified in protocol. This dosing arm is currently on hold.
Other Name: CNF2024
Subjects in Schedule B will take BIIB021 in the morning at approximately 0800 with at least 6 ounces of water following an overnight fast (beginning at midnight). The second dose will be taken, following at least a 2-hour fast, 12 hours (+/- 2 hours) after the first dose, except on Day 1 of Cycle 1 and Day 1 of Cycle 2.
Twice daily dosing
Other Name: CNF2024
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.
|United States, California|
|Encinitas, California, United States, 92024|
|Santa Monica, California, United States, 90404|
|United States, Texas|
|San Antonio, Texas, United States, 78229|