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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

February 8, 2008
June 7, 2012
February 2008
July 2010   (final data collection date for primary outcome measure)
Safety and tolerability of BIIB021 [ Time Frame: As specified in protocol ] [ Designated as safety issue: Yes ]
Safety and tolerability of BIIB021 [ Time Frame: As specified in protocol ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00618735 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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

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.

Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Solid Tumors
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
December 2010
July 2010   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00618735
120ST103
Yes
Biogen Idec MD, Biogen Idec
Biogen Idec
Not Provided
Not Provided
Biogen Idec
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP