StrateGIST 3: IDRX/Sunitinib for GIST after imatinib - Clinical Trial

¿Cuál es el Propósito de este estudio?

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.

¿Cuál es la Condición que se está estudiando?

GISTs are rare tumors in the stomach or intestines. Doctors use a medicine called imatinib to treat them. If the tumors spread or cannot be removed with surgery, and imatinib stops working, doctors try other treatments to help the patient.

¿Quién puede participar en el Estudio?

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.

Grupo etario
Adultos

¿Qué Implica?

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.

Detalles del Estudio

Título Completo
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)
Investigador Principal
Número de Protocolo
IRB: PRO00118961
NCT: NCT07218926
Fase
Phase III
ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción
Participate
Apoye la investigación de Duke Health o rinda homenaje a un ser querido con un regalo conmemorativo.
Contribuya a Duke Health