An Open-Label, 18FDG-PET Pharmacodynamic Assessment of the Effect of BIIB021 in Subjects With Gastrointestinal Stromal Tumors (GIST)
1 other identifier
interventional
20
1 country
3
Brief Summary
This study will examine the effect of BIIB021 on GIST growth and metabolism.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2008
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 8, 2008
CompletedFirst Posted
Study publicly available on registry
February 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedOctober 2, 2015
March 1, 2011
2.2 years
February 8, 2008
September 17, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in FDG-PET imaging
28 days
Secondary Outcomes (1)
Characterize the safety profile of BIIB021
Duration of study
Study Arms (1)
1
EXPERIMENTALBIIB021
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (3)
Reseach Facility
Encinitas, California, United States
Research Site
Santa Monica, California, 90404, United States
Reseach Facility
San Antonio, Texas, United States
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2008
First Posted
February 20, 2008
Study Start
February 1, 2008
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
October 2, 2015
Record last verified: 2011-03