Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 2 study of Cancer and Gastrointestinal Stromal Tumors, sponsored by Adam Burgoyne, MD, PhD.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To determine overall response rate at 6 months for TMZ therapy in patients with SDH-mutant/deficient GIST. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
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 |
What the registry record for NCT03556384 still lists
NCT03556384 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03556384's enrollment target sits among peer trials
23 548th of 615 higher than 63 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Treatment of Immune Checkpoint Inhibitor-related Diarrhea and/ or Colitis With Ustekinumab in Cancer Patients
RECRUITING · Phase 2
-
TRIPS - Treatment to Improve Depression and/or Anxiety Using Psilocybin-assisted Psychotherapy in Cancer Survivors
RECRUITING · Phase 2
-
CAncer TReatment INformed by the Molecular Tumor Board At Dartmouth
RECRUITING · Phase 2
-
Isa-Rd for Frail and/or Much Older Patients With Newly Diagnosed Multiple Myeloma
RECRUITING · Phase 2
-
Acupuncture for People Experiencing Period Loss Due to Chemotherapy
RECRUITING · Phase 2
-
Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03616041 · 23 participants
Capsule Endoscopy for Severe Hematochezia
- NCT04348747 · 23 participants · Phase 2
Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer
- NCT04587687 · 23 participants · Phase 2
Brentuximab Vedotin and Bendamustine for the Treatment of Relapsed or Refractory Follicular Lymphoma
- NCT04715022 · 23 participants · Phase 1
Sympathetic-vascular Dysfunction in Obesity and Insulin Resistance (Vitamin C Study)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI