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Sponsored by: |
Biogen Idec |
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Information provided by: | Biogen Idec |
ClinicalTrials.gov Identifier: | NCT00618735 |
The purpose of the study is to see if daily and twice daily administration of BIIB021 is tolerated in patients with advanced solid tumors.
Condition | Intervention | Phase |
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Advanced Solid Tumors |
Drug: BIIB021 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
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 |
Estimated Enrollment: | 68 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Once daily dosing
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Drug: BIIB021
Dosage, frequency (once daily), and duration as specified in protocol. This dosing arm is currently on hold.
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2: Experimental
Twice daily dosing
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Drug: BIIB021
Twice daily dosing
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Required laboratory values:
Exclusion Criteria:
Contact: Biogen Idec | oncologyclinicaltrials@biogenidec.com |
United States, California | |
Research Site | Recruiting |
Los Angeles, California, United States | |
United States, Texas | |
Research Site | Recruiting |
San Antonio, Texas, United States |
Responsible Party: | Biogen Idec ( Biogen Idec MD ) |
Study ID Numbers: | 120ST103 |
Study First Received: | February 8, 2008 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00618735 |
Health Authority: | United States: Food and Drug Administration |