NCT05366816 is a Phase 2 clinical trial of Sunitinib in Gastrointestinal Stromal Tumors, sponsored by University of Miami.

Who is sponsoring NCT05366816?

NCT05366816 is sponsored by University of Miami.

What drugs are being tested in NCT05366816?

Interventions in NCT05366816: Sunitinib, Regorafenib.

What condition does NCT05366816 study?

NCT05366816 studies Gastrointestinal Stromal Tumors.

Is NCT05366816 still recruiting?

NCT05366816 is currently recruiting now. Last updated 9 September 2025.

Last reviewed 2025-09-09 · How we verify

NCT05366816

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST

Recruiting now Phase 2 Last updated 9 September 2025

What this trial tests

Phase 2 trial testing Sunitinib in Gastrointestinal Stromal Tumors in 48 participants. Currently enrolling.

Timeline

17 October 2023

Primary endpoint
31 December 2026

31 December 2028

Quick facts

Lead sponsor	University of Miami
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	17 October 2023
Primary completion	31 December 2026
Estimated completion	31 December 2028
Sites	1 location across United States

Drugs / interventions tested

Sunitinib (sunitinib) — full drug profile →
Regorafenib — full drug profile →

Conditions studied

Gastrointestinal Stromal Tumors — all drugs for Gastrointestinal Stromal Tumors →

Sponsor

University of Miami

Who can join

18 and older, any sex, with Gastrointestinal Stromal Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this research is to test if mutations (changes in DNA) in exons (segment of DNA or RNA containing information that has the instructions for making proteins) in the KIT gene can be used to predict the body's response to standard of care treatment.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Emerging Targeted Therapeutic Strategies to Overcome Imatinib Resistance of Gastrointestinal Stromal Tumors.
Masucci MT, Motti ML, Minopoli M, Di Carluccio G, et al · · 2023 · cited 10× · PMID 37046997 · DOI 10.3390/ijms24076026
Targeting the Unmet Need in Gastrointestinal Stromal Tumors: A Contemporary Review of Investigational Clinical Trials and Therapeutic Landscape.
Belančić A, Prejac J, Golčić M, Adžić G, et al · · 2026 · PMID 42075805 · DOI 10.3390/ph19040548

Verify or expand the search:

Other trials of Sunitinib

Trials testing the same drug.

NCT07218926 — A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatini · Phase 3 · recruiting
NCT07165418 — A Comparison of Vorolanib Tablets Combined With Everolimus Versus Sunitinib in Patients With Advanced Renal Cell Carcino · Phase 3 · not yet recruiting
NCT05773274 — Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroe · Phase 2 · recruiting
NCT06032728 — Multimodal Recurrence Scoring System for Stratifying Stage III Clear Cell Renal Cell Carcinoma of Receiving Adjuvant Tre · NA · not yet recruiting
NCT05745142 — A Study to go Back Into Records and Observe How People With Metastatic Renal Cell Carcinoma (mRCC) Who Received a Medici · completed

Other recruiting trials for Gastrointestinal Stromal Tumors

Currently open trials in the same condition.

NCT06805825 — A Study of the c-Kit Specific Antibody-Drug Conjugate NN3201 for Advanced and/or Metastatic Solid Tumors Known to Expres · Phase 1 · recruiting
NCT06326346 — GIST Oral Paclitaxel(Liporaxel) · Phase 2 · recruiting
NCT06087263 — Phase 2 Study to Evaluate the Efficacy of Regorafenib in Specific GIST Mutation Subsets (KIT Exon 17, 18, or 14 Mutation · Phase 2 · active not recruiting
NCT05905887 — Rivoceranib Plus Paclitaxel in Patients With Gastrointestinal Stromal Tumor · Phase 2 · recruiting
NCT05661643 — The Efficacy and Safety of Temozolomide in SDH-deficient GIST · Phase 2 · recruiting

Other University of Miami trials

Trials by the same sponsor.

NCT06003712 — Exploring the Effect of Mindfulness on Quality of Life (QoL) in Spinal Cord Injury (SCI) · NA · not yet recruiting
NCT06077071 — MRIdian "RADAR" Trial · NA · not yet recruiting
NCT07472413 — Alternate Pre-med in Anti-Cluster of Differentiation 20 (CD20) Pilot Project · Phase 3 · not yet recruiting
NCT07322289 — Antibiotic-coated Braided Suture Study · NA · not yet recruiting
NCT07469592 — eHealth Mindfulness-based Music Therapy Intervention for Patients Undergoing Stem Cell Transplantation · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05366816 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Miami
Last refreshed: 9 September 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05366816.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing