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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.

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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.

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

FieldValue
Enrollment Target 23 participants
Start Date 2018-09-12
Est. Completion 2026-06
Phase Phase 2

Sponsor

Adam Burgoyne, MD, PhD

1 total trials

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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