Once or Twice Daily Administration of BIIB021 to Subjects With Advanced Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00618735|
Recruitment Status : Completed
First Posted : February 20, 2008
Last Update Posted : December 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors||Drug: BIIB021||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||December 2010|
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
- Safety and tolerability of BIIB021 [ Time Frame: As specified in protocol ]
- PK and PD of BIIB021 [ Time Frame: As specified in protocol ]
- Antitumor activity [ Time Frame: As specified in protocol ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00618735
|United States, California|
|Encinitas, California, United States, 92024|
|Santa Monica, California, United States, 90404|
|United States, Texas|
|San Antonio, Texas, United States, 78229|