Regorafenib for Gastrointestinal Stromal Tumors

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Miami, Miami, FL
Gastrointestinal Stromal Tumors
Regorafenib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Gastrointestinal Stromal Tumors

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 3 years

Up to 12 months
Number of Participants Achieving Clinical Benefit
Number of Participants Achieving Overall Response
Up to 13 months
Incidence of Treatment-Related Toxicity and Adverse Events
Up to 3 years
Overall Survival (OS)
Progression-Free Survival (PFS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Gastrointestinal Stromal Tumors

Trial Design

2 Treatment Groups

Group B: KIT Exon 17 receiving Regorafenib
1 of 2
Group A: KIT Exon 13 receiving Sunitinib
1 of 2
Experimental Treatment

48 Total Participants · 2 Treatment Groups

Primary Treatment: Regorafenib · No Placebo Group · Phase 2

Group B: KIT Exon 17 receiving RegorafenibExperimental Group · 2 Interventions: Regorafenib, Sunitinib · Intervention Types: Drug, Drug
Group A: KIT Exon 13 receiving SunitinibExperimental Group · 2 Interventions: Regorafenib, Sunitinib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Regorafenib
2014
Completed Phase 2
~1390
Sunitinib
2014
Completed Phase 3
~4380

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years
Closest Location: University of Miami · Miami, FL
Photo of University of Miami 1Photo of University of Miami 2Photo of University of Miami 3
1991First Recorded Clinical Trial
3 TrialsResearching Gastrointestinal Stromal Tumors
621 CompletedClinical Trials

Who is running the clinical trial?

University of MiamiLead Sponsor
780 Previous Clinical Trials
381,714 Total Patients Enrolled
Jonathan Trent, MD, PhDPrincipal InvestigatorUniversity of Miami
2 Previous Clinical Trials
68 Total Patients Enrolled
2 Trials studying Gastrointestinal Stromal Tumors
68 Patients Enrolled for Gastrointestinal Stromal Tumors

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have histologically confirmed metastatic or unresectable GIST.
You have a performance status of 0 to 2.
You are eligible for this study if you are ≥ 18 years of age.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.