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An Open-Label, 18FDG-PET Pharmacodynamic Assessment of the Effect of BIIB021 in Subjects With Gastrointestinal Stromal Tumors (GIST)

Sponsor
Biogen (Industry)
Overall Status
Completed
CT.gov ID
NCT00618319
Collaborator
(none)
20
Enrollment
3
Locations
1
Arm
26
Duration (Months)
6.7
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will examine the effect of BIIB021 on GIST growth and metabolism.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, 18FDG-PET Pharmacodynamic Assessment of the Effect of BIIB021 in Subjects With Gastrointestinal Stromal Tumors (GIST) Refractory to, Intolerant of, or Not a Candidate for Imatinib and Sunitinib Treatment
Study Start Date :
Feb 1, 2008
Actual Primary Completion Date :
Apr 1, 2010
Actual Study Completion Date :
Apr 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

BIIB021

Drug: BIIB021
Dose, schedule, and duration specified in protocol
Other Names:
  • CNF2024

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes in FDG-PET imaging [28 days]

    Secondary Outcome Measures

    1. Characterize the safety profile of BIIB021 [Duration of study]

    Eligibility Criteria

    Criteria

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

    • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.

    • Age greater than or equal to 18 years at the time of informed consent.

    • Pathologically confirmed GIST refractory to, intolerant of, or not a candidate for imatinib and sunitinib therapy.

    • FDG PET standard uptake value (SUVmax; averaged over a maximum of 5 lesions) greater than or equal to 2 at screening.

    • ECOG performance status of less than or equal to 2.

    • Lab values consistent with adequate renal hepatic and bone marrow function.

    • Must utilize effective contraception.

    Exclusion Criteria:

    • Prior treatment with imatinib, sunitinib, or sorafenib with in 14 days of day 1.

    • Prior treatment with Hsp90 inhibitors at any time.

    • Prior antitumor therapies including prior experimental agents, approved antitumor small molecules (excluding imatinib, sunitinib, or sorafenib) and biologics, or radiotherapy with in 28 days or <3 half lives (whichever is longer) before start of BIIB021treatment.

    • Diabetes treated with insulin and/ or concurrent severe or uncontrolled other medical disease (i.e, systemic infection, hypertension, coronary artery disease, congestive heart failure).

    • History of/ or predisposition to seizures.

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Biogen

    Investigators

    • Study Director: Medical Director, Biogen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biogen
    ClinicalTrials.gov Identifier:
    NCT00618319
    Other Study ID Numbers:
    • 120GS201
    First Posted:
    Feb 20, 2008
    Last Update Posted:
    Oct 2, 2015
    Last Verified:
    Mar 1, 2011
    Additional relevant MeSH terms:
    Gastrointestinal Stromal Tumors

    Study Results

    No Results Posted as of Oct 2, 2015