Back to resultsAn Open-Label, 18FDG-PET Pharmacodynamic Assessment of the Effect of BIIB021 in Subjects With Gastrointestinal Stromal Tumors (GIST)
Primary Purpose
GIST
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BIIB021
Sponsored by
About this trial
This is an interventional treatment trial for GIST
Eligibility Criteria
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.
Sites / Locations
- Reseach Facility
- Research Site
- Reseach Facility
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
BIIB021
Outcomes
Primary Outcome Measures
Changes in FDG-PET imaging
Secondary Outcome Measures
Characterize the safety profile of BIIB021
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00618319
Brief Title
An Open-Label, 18FDG-PET Pharmacodynamic Assessment of the Effect of BIIB021 in Subjects With Gastrointestinal Stromal Tumors (GIST)
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 Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will examine the effect of BIIB021 on GIST growth and metabolism.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GIST
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
BIIB021
Intervention Type
Drug
Intervention Name(s)
BIIB021
Other Intervention Name(s)
CNF2024
Intervention Description
Dose, schedule, and duration specified in protocol
Primary Outcome Measure Information:
Title
Changes in FDG-PET imaging
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Characterize the safety profile of BIIB021
Time Frame
Duration of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Reseach Facility
City
Encinitas
State/Province
California
Country
United States
Facility Name
Research Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Reseach Facility
City
San Antonio
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Open-Label, 18FDG-PET Pharmacodynamic Assessment of the Effect of BIIB021 in Subjects With Gastrointestinal Stromal Tumors (GIST)
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