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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 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.

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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.

Conditions Studied

GIST

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

FieldValue
Enrollment Target 54 participants
Start Date 2023-12-13
Est. Completion 2028-12
Phase Phase 3

Sponsor

Deciphera Pharmaceuticals

21 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05734105

The ClinicalTrials.gov registry entry for NCT05734105 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 129-participant average among 8 other GIST trials with a reported enrollment target (58% lower). The listed sponsor is Deciphera Pharmaceuticals, which has 21 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.