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

This study has been completed.

Sponsor:

Information provided by:

Biogen Idec

ClinicalTrials.gov Identifier:

NCT00618735

First received: February 8, 2008

Last updated: June 7, 2012

Last verified: January 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	February 8, 2008
Last Updated Date	June 7, 2012
Start Date ^ICMJE	February 2008
Primary Completion Date	July 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 3, 2008)	Safety and tolerability of BIIB021 [ Time Frame: As specified in protocol ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: February 8, 2008)	Safety and tolerability of BIIB021 [ Time Frame: As specified in protocol ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00618735 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 8, 2008)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Once or Twice Daily Administration of BIIB021 to Subjects With Advanced Solid Tumors
Official Title ^ICMJE	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
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.
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 ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Advanced Solid Tumors
Intervention ^ICMJE	Drug: BIIB021 Dosage, frequency (once daily), and duration as specified in protocol. This dosing arm is currently on hold. Other Name: CNF2024 Drug: BIIB021 Twice daily dosing Other Name: CNF2024
Study Arm (s)	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). Intervention: Drug: BIIB021 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. Intervention: Drug: BIIB021
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	68
Completion Date	December 2010
Primary Completion Date	July 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00618735
Other Study ID Numbers ^ICMJE	120ST103
Has Data Monitoring Committee	Yes
Responsible Party	Biogen Idec MD, Biogen Idec
Study Sponsor ^ICMJE	Biogen Idec
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Biogen Idec
Verification Date	January 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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