NCT00618735

Once or Twice Daily Administration of BIIB021 to Subjects With Advanced Solid Tumors

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to see if daily and twice daily administration of BIIB021 is tolerated in patients with advanced solid tumors.

Detailed description

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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	BIIB021	Dosage, frequency (once daily), and duration as specified in protocol. This dosing arm is currently on hold.
DRUG	BIIB021	Twice daily dosing

Timeline

• Start date: 2008-02-01
• Primary completion: 2010-07-01
• Completion: 2010-12-01
• First posted: 2008-02-20
• Last updated: 2016-12-29

Locations

3 sites across 1 country: United States