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

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ClinicalTrials.gov Identifier: NCT00618735
Recruitment Status : Completed
First Posted : February 20, 2008
Last Update Posted : December 29, 2016
Sponsor:
Information provided by:
Biogen

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: BIIB021 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
Experimental: 1
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).
Drug: BIIB021
Dosage, frequency (once daily), and duration as specified in protocol. This dosing arm is currently on hold.
Other Name: CNF2024
Experimental: 2
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.
Drug: BIIB021
Twice daily dosing
Other Name: CNF2024



Primary Outcome Measures :
  1. Safety and tolerability of BIIB021 [ Time Frame: As specified in protocol ]

Secondary Outcome Measures :
  1. PK and PD of BIIB021 [ Time Frame: As specified in protocol ]
  2. Antitumor activity [ Time Frame: As specified in protocol ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

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


Locations
United States, California
Research Site
Encinitas, California, United States, 92024
Research Site
Santa Monica, California, United States, 90404
United States, Texas
Research Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Biogen