Purpose of this Study
People in the study will be split into two groups. One group will take a medicine called IDRX-42 every day as a white tablet. The other group will take a medicine called sunitinib in a capsule for 4 weeks, then stop for 2 weeks, and keep repeating that schedule.
Both medicines are taken by mouth with a glass of water. Before starting, each person will have tests to make sure it is safe for them to join the study.
Who Can Participate?
Eligibility
This study is for adults who have a rare kind of stomach or intestine tumor called GIST. These tumors cannot be removed with surgery or have spread to other parts of the body. People in the study must have tried a medicine called imatinib, but it either did not work or caused problems.
Doctors need to check the person's tumor type using special tests. They also need a sample of the tumor to study later. People must be mostly healthy and not have serious heart problems, infections, or brain tumors. They cannot join if they had certain surgeries recently or took other cancer medicines before.
If someone wants to know more or join the study, they can call Alicia Wilkerson at 919-681-6807.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is trying to find the safest and best amount of a new medicine called IDRX-42. Doctors want to see if it helps people feel better and works well compared to another medicine called sunitinib. The study is for people who have a serious kind of tumor in their stomach or intestines called GIST.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase 3, Randomized, Multicenter, Open-Label Study of IDRX-42 (GSK6042981) versus Sunitinib in Participants with Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) after Imatinib Therapy (StrateGIST 3)
Principal Investigator
Juneko
Grilley Olson
Protocol Number
PRO00118961
NCT ID
NCT07218926
Phase
III
Enrollment Status
Pending Open to Enrollment