Clinical trial · Interventional
An Open-Label, 18FDG-PET Pharmacodynamic Assessment of the Effect of BIIB021 in Subjects With Gastrointestinal Stromal Tumors (GIST)
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
NCT00618319CI-TRIAL-00019309completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will examine the effect of BIIB021 on GIST growth and metabolism.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| GIST | Gastrointestinal Stromal Tumor | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BIIB021 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- BIIB021
- interventionNames
- Drug: BIIB021
Primary outcomes (1)
- measure
- Changes in FDG-PET imaging
- timeFrame
- 28 days
Secondary outcomes (1)
- measure
- Characterize the safety profile of BIIB021
- timeFrame
- Duration of study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.