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

Sponsor
Biogen (Industry)
Overall Status
Completed
CT.gov ID
NCT00618735
Collaborator
(none)
68
Enrollment
3
Locations
2
Arms
34
Duration (Months)
22.7
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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
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 Design

Study Type:
Interventional
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 :
Feb 1, 2008
Actual Primary Completion Date :
Jul 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

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 Names:
  • 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 Names:
  • CNF2024

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety and tolerability of BIIB021 [As specified in protocol]

    Secondary Outcome Measures

    1. PK and PD of BIIB021 [As specified in protocol]

    2. Antitumor activity [As specified in protocol]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Encinitas California United States 92024
    2 Research Site Santa Monica California United States 90404
    3 Research Site San Antonio Texas United States 78229

    Sponsors and Collaborators

    • Biogen

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00618735
    Other Study ID Numbers:
    • 120ST103
    First Posted:
    Feb 20, 2008
    Last Update Posted:
    Dec 29, 2016
    Last Verified:
    Dec 1, 2016
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Dec 29, 2016