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NCT03556384 · ClinicalTrials.gov registry record · Phase 2
Temozolomide (TMZ) in Advanced Succinate Dehydrogenase (SDH)-Mutant/Deficient Gastrointestinal Stromal Tumor (GIST)
A Phase 2 study of Cancer and Gastrointestinal Stromal Tumors, sponsored by Adam Burgoyne, MD, PhD.
- Active
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
- 4
- Study locations
NCT03556384 is a Phase 2 study of Cancer and Gastrointestinal Stromal Tumors that is active but no longer recruiting, run by Adam Burgoyne, MD, PhD. The registered enrollment target is 23 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT03556384, a Phase 2 study of Cancer and Gastrointestinal Stromal Tumors, is active but no longer recruiting, sponsored by Adam Burgoyne, MD, PhD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
- 4
- Study locations
Study Summary
Funding Source - FDA OOPD FDA-approved products for patients with unresectable or metastatic GIST include therapies such as imatinib and sunitinib. Although there are FDA-approved products for the treatment of advanced/metastatic GIST, these therapies are known to be ineffective in the SDH-mutant/deficient subtype and no known effective therapies exist. The purpose of this study is to investigate SDH-Mutant/Deficient Gastrointestinal Stromal cancer's response to the drug Temozolomide (TMZ) and aim to improve patient outcomes. Temozolomide is approved by the FDA for the treatment of newly diagnosed glioblastoma multiforme (GBM) and refractory anaplastic astrocytoma cancers. Temozolomide is considered experimental because it is not approved by the FDA for the treatment of SDH-Mutant/Deficient Gastrointestinal Stromal Tumor.
Conditions Studied
Interventions
- DRUG Temozolomide
Study Locations (4)
California
- UC San Diego Moores Cancer Center - La Jolla
Florida
- University of Miami - Miami
Oregon
- Oregon Health & Science University - Portland
Pennsylvania
- Fox Chase Cancer Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2018-09-12 |
| Est. Completion | 2026-06 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03556384
The ClinicalTrials.gov registry entry for NCT03556384 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower). The listed sponsor is Adam Burgoyne, MD, PhD, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Cancer appearing as the primary indexed condition, and to 1 intervention - of which Temozolomide is the first listed.
NCT03556384 reports 4 study locations spanning 4 distinct geographic areas - top geographies include California, Florida, Oregon.
Frequently Asked Questions
What is clinical trial NCT03556384 about?
NCT03556384 is a clinical study titled "Temozolomide (TMZ) in Advanced Succinate Dehydrogenase (SDH)-Mutant/Deficient Gastrointestinal Stromal Tumor (GIST)". Funding Source - FDA OOPD FDA-approved products for patients with unresectable or metastatic GIST include therapies such as imatinib and sunitinib. Although there are FDA-approved products for the treatment of advanced/metastatic GIST, these therapies are known to be ineffective in the SDH-mutant/d...
What is the current status of trial NCT03556384?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2018-09-12. Estimated completion is 2026-06.
What conditions does trial NCT03556384 study?
This clinical trial studies the following conditions: Cancer, Gastrointestinal Stromal Tumors, GIST, Sdh.
What interventions are being tested in trial NCT03556384?
The interventions under investigation include: Temozolomide (DRUG).
Who is sponsoring clinical trial NCT03556384?
This trial is sponsored by Adam Burgoyne, MD, PhD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03556384 being conducted?
This trial has 4 study locations across California, Florida, Oregon, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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