Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05734105 · ClinicalTrials.gov registry record · Phase 3
A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib
A Phase 3 study of GIST, sponsored by Deciphera Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 54
- Enrollment target
- 20
- Study locations
NCT05734105: Active Phase 3 study of GIST, sponsored by Deciphera Pharmaceuticals.
NCT05734105 is a Phase 3 study of GIST that is active but no longer recruiting, run by Deciphera Pharmaceuticals. The registered enrollment target is 54 participants, below the 129-participant average among 8 other GIST trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05734105, a Phase 3 study of GIST, is active but no longer recruiting, sponsored by Deciphera Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 54 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 3, 2-arm, randomized, open-label, global, multicenter study comparing the efficacy of ripretinib to sunitinib in participants with GIST who progressed on first-line treatment with imatinib, harbor co-occurring KIT exons 11+17/18 mutations, and are without KIT exon 9, 13, or 14 mutations. Upon disease progression as determined by an independent radiologic review, participants randomized to sunitinib will be given the option to either crossover to receive ripretinib 150 mg QD or discontinue sunitinib.
Primary Outcome
The time from randomization until documented progressive disease (PD) based on IRR per mRECIST or death due to any cause, whichever occurs first.
Conditions Studied
Interventions
- DRUG Sunitinib
- DRUG Ripretinib
Study Locations (20)
Florida
- Mayo Clinic Florida - Jacksonville
- Sylvester Comprehensive Cancer Center - Miami
- Moffitt Cancer Center - Tampa
Massachusetts
- Boston Medical Center - Boston
- Dana-Farber Cancer Institute - Boston
Minnesota
- M Health Fairview University of Minnesota Medical Center - Minneapolis
- Mayo Clinic - Rochester
New York
- Memorial Sloan Kettering Cancer Center - New York
- Northwell Health Cancer Institute/ R.J. Zuckerberg Cancer Center - New York
Ohio
- Cleveland Clinic - Cleveland
- The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center - Columbus
California
- UC San Diego Moores Cancer Center - La Jolla
Connecticut
- Yale University - New Haven
Maryland
- Johns Hopkins Hospital - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2023-12-13 |
| Est. Completion | 2028-12 |
| Phase | Phase 3 |
What the registry record for NCT05734105 still lists
NCT05734105 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 129-participant average among 8 other GIST trials with a reported enrollment target (58% lower).
The record links to 1 condition, with GIST appearing as the primary indexed condition, and to 2 interventions - of which Sunitinib is the first listed.
NCT05734105 names 20 study sites across 14 states, led by Florida, Massachusetts, Minnesota.
Frequently Asked Questions
What is clinical trial NCT05734105 about?
NCT05734105 is a clinical study titled "A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib". This is a Phase 3, 2-arm, randomized, open-label, global, multicenter study comparing the efficacy of ripretinib to sunitinib in participants with GIST who progressed on first-line treatment with imatinib, harbor co-occurring KIT exons 11+17/18 mutations, and are without KIT exon 9, 13, or 14 mutati...
What is the current status of trial NCT05734105?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 54 participants. The study started on 2023-12-13. Estimated completion is 2028-12.
What conditions does trial NCT05734105 study?
This clinical trial studies the following conditions: GIST.
What interventions are being tested in trial NCT05734105?
The interventions under investigation include: Sunitinib (DRUG), Ripretinib (DRUG).
Who is sponsoring clinical trial NCT05734105?
This trial is sponsored by Deciphera Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05734105 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for GIST
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 NCT05734105's enrollment target sits among peer trials
54 4th of 8 higher than 5 of 8 other GIST trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other GIST 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
-
(VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST
COMPLETED · Phase 3
-
Phase I Trial to Determine the Dose and Evaluate the PK and Safety of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive Tumors
RECRUITING · Phase 1
-
A Study of Inlexisertib (DCC-3116) in Combination With Anticancer Therapies in Participants With Advanced Malignancies
RECRUITING · Phase 1
-
SARC044: A Phase II Trial of Bezuclastinib in Combination With Sunitinib in Patients With GIST
ACTIVE NOT RECRUITING · Phase 2
-
Temozolomide (TMZ) in Advanced Succinate Dehydrogenase (SDH)-Mutant/Deficient Gastrointestinal Stromal Tumor (GIST)
ACTIVE NOT RECRUITING · Phase 2
-
Clinical Registry of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract
COMPLETED
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
- NCT01269853 · 54 participants · Phase 1
Repeated Super-selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Relapsed GBM and AA
- NCT02390752 · 54 participants · Phase 1
Phase I Trial of TURALIO(R) (Pexidartinib, PLX3397) in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) and Tenosynovial Giant Cell Tumor ...
- NCT02991248 · 54 participants · NA
Improve Dynamic Lateral Balance of Humans With SCI
- NCT02993900 · 54 participants · NA
Image-Guided Gynecologic Brachytherapy
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