Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07218926

A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy

Led by GlaxoSmithKline · Updated on 2026-04-03

450

Participants Needed

84

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to find out if a new drug, called IDRX-42 (also known as GSK6042981), is effective in treating adults with a type of cancer called Gastrointestinal Stromal Tumors (GIST) when compared to another drug named sunitinib. The study will see if IDRX-42 works well and is safe for participants whose GIST has spread or cannot be surgically removed, and who have already taken the drug imatinib.

CONDITIONS

Official Title

A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants with histologically or cytologically confirmed GIST that is metastatic and/or surgically unresectable.
  • Documented disease progression on or intolerance to imatinib administered for first-line treatment of unresectable/metastatic disease.
  • Tumor tissue must be available to be submitted to the central laboratory for retrospective biomarker analysis. The sample may be from archival tissue or a new biopsy. Tissue samples are not required to be submitted centrally prior to randomization.
Not Eligible

You will not qualify if you...

  • Known untreated or active central nervous system metastases.
  • Participants with a known allergy or hypersensitivity to any component of IDRX-42 (GSK6042981) or sunitinib. Participants with a history of Stevens-Johnson syndrome on a prior Tyrosine kinase inhibitor (TKI) are excluded.
  • Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas [e.g., breast, cervix, bladder] that have been resected with no evidence of metastatic disease.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 84 locations

1

GSK Investigational Site

Phoenix, Arizona, United States, 85054

Actively Recruiting

2

GSK Investigational Site

Jacksonville, Florida, United States, 41076

Actively Recruiting

3

GSK Investigational Site

Orlando, Florida, United States, 32806

Actively Recruiting

4

GSK Investigational Site

Iowa City, Iowa, United States, 52242

Actively Recruiting

5

GSK Investigational Site

Overland Park, Kansas, United States, 66210

Actively Recruiting

6

GSK Investigational Site

Boston, Massachusetts, United States, 02114-2696

Actively Recruiting

7

GSK Investigational Site

Boston, Massachusetts, United States, 02215

Actively Recruiting

8

GSK Investigational Site

Rochester, Minnesota, United States, 55905

Actively Recruiting

9

GSK Investigational Site

Omaha, Nebraska, United States, 68130

Actively Recruiting

10

GSK Investigational Site

Lake Success, New York, United States, 11042

Actively Recruiting

11

GSK Investigational Site

New York, New York, United States, 10032

Actively Recruiting

12

GSK Investigational Site

Durham, North Carolina, United States, 27710

Actively Recruiting

13

GSK Investigational Site

Philadelphia, Pennsylvania, United States, 19106

Actively Recruiting

14

GSK Investigational Site

Philadelphia, Pennsylvania, United States, 19111

Actively Recruiting

15

GSK Investigational Site

Knoxville, Tennessee, United States, 37920

Actively Recruiting

16

GSK Investigational Site

Dallas, Texas, United States, 75246

Actively Recruiting

17

GSK Investigational Site

Houston, Texas, United States, 77030

Actively Recruiting

18

GSK Investigational Site

Tacoma, Washington, United States, 98405

Actively Recruiting

19

GSK Investigational Site

Melbourne, Victoria, Australia, 3004

Actively Recruiting

20

GSK Investigational Site

Leuven, Belgium, 3000

Actively Recruiting

21

GSK Investigational Site

Barretos, São Paulo, Brazil, 14784-400

Actively Recruiting

22

GSK Investigational Site

Porto Alegre, Brazil, 90020-090

Actively Recruiting

23

GSK Investigational Site

Recife, Brazil, 50040000

Actively Recruiting

24

GSK Investigational Site

Vitória, Brazil, 29043-260

Actively Recruiting

25

GSK Investigational Site

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

26

GSK Investigational Site

Montreal, Quebec, Canada, H4A 3J1

Actively Recruiting

27

GSK Investigational Site

Beijing, China, 100036

Actively Recruiting

28

GSK Investigational Site

Jinan, China, 250021

Actively Recruiting

29

GSK Investigational Site

Bordeaux, France, 33076

Actively Recruiting

30

GSK Investigational Site

Lille, France, 59000

Actively Recruiting

31

GSK Investigational Site

Lyon, France, 69373

Actively Recruiting

32

GSK Investigational Site

Saint-Herblain, France, 44805

Actively Recruiting

33

GSK Investigational Site

Villejuif, France, 94805

Actively Recruiting

34

GSK Investigational Site

Berlin, Germany

Actively Recruiting

35

GSK Investigational Site

Meldola, FC, Italy, 47014

Actively Recruiting

36

GSK Investigational Site

Candiolo, Italy, 10060

Actively Recruiting

37

GSK Investigational Site

Milan, Italy, 20133

Actively Recruiting

38

GSK Investigational Site

Palermo, Italy

Actively Recruiting

39

GSK Investigational Site

Roma, Italy, 00128

Actively Recruiting

40

GSK Investigational Site

Chiba, Japan, 277-8577

Actively Recruiting

41

GSK Investigational Site

Ehime, Japan, 791-0280

Actively Recruiting

42

GSK Investigational Site

Fukuoka, Japan, 812-8582

Actively Recruiting

43

GSK Investigational Site

Hokkaido, Japan, 060-8648

Actively Recruiting

44

GSK Investigational Site

Kanagawa, Japan, 247-8533

Actively Recruiting

45

GSK Investigational Site

Kumamoto, Japan, 860-8556

Actively Recruiting

46

GSK Investigational Site

Miyagi, Japan, 980-8574

Actively Recruiting

47

GSK Investigational Site

Osaka, Japan, 565-0871

Actively Recruiting

48

GSK Investigational Site

Tokyo, Japan, 104-0045

Actively Recruiting

49

GSK Investigational Site

Tokyo, Japan, 135-8550

Actively Recruiting

50

GSK Investigational Site

Nijmegen, Netherlands, 6525 GA

Actively Recruiting

51

GSK Investigational Site

Oslo, Norway, 0379

Actively Recruiting

52

GSK Investigational Site

Kielce, Poland, 25-640

Actively Recruiting

53

GSK Investigational Site

Poznan, Poland, 60-569

Actively Recruiting

54

GSK Investigational Site

Warsaw, Poland, 02-781

Actively Recruiting

55

GSK Investigational Site

Bucharest, Romania, 013823

Actively Recruiting

56

GSK Investigational Site

Craiova, Romania, 200542

Actively Recruiting

57

GSK Investigational Site

Timișoara, Romania, 300166

Actively Recruiting

58

GSK Investigational Site

Daegu, South Korea, 41404

Actively Recruiting

59

GSK Investigational Site

Seongnam-si Gyeonggi-do, South Korea, 463 707

Actively Recruiting

60

GSK Investigational Site

Seoul, South Korea, 03080

Actively Recruiting

61

GSK Investigational Site

Seoul, South Korea, 06351

Actively Recruiting

62

GSK Investigational Site

Seoul, South Korea, 120-752

Actively Recruiting

63

GSK Investigational Site

Seoul, South Korea, 138-736

Actively Recruiting

64

GSK Investigational Site

Suwon Kyunggi-do, South Korea, 16499

Actively Recruiting

65

GSK Investigational Site

Yangsan, South Korea, 626-770

Actively Recruiting

66

GSK Investigational Site

Barcelona, Spain, 08025

Actively Recruiting

67

GSK Investigational Site

Madrid, Spain, 28007

Actively Recruiting

68

GSK Investigational Site

Madrid, Spain, 28040

Actively Recruiting

69

GSK Investigational Site

Madrid, Spain, 28040

Actively Recruiting

70

GSK Investigational Site

Oviedo, Spain, 33006

Actively Recruiting

71

GSK Investigational Site

Seville, Spain, 41013

Actively Recruiting

72

GSK Investigational Site

Valencia, Spain, 46009

Actively Recruiting

73

GSK Investigational Site

Zaragoza, Spain, 50009

Actively Recruiting

74

GSK Investigational Site

Changhua, Taiwan, 500

Actively Recruiting

75

GSK Investigational Site

Kaohsiung City, Taiwan, 807

Actively Recruiting

76

GSK Investigational Site

Kaohsiung City, Taiwan, 833

Actively Recruiting

77

GSK Investigational Site

Taipei, Taiwan, 100

Actively Recruiting

78

GSK Investigational Site

Taipei, Taiwan, 112

Actively Recruiting

79

GSK Investigational Site

Taoyuan, Taiwan, 333

Actively Recruiting

80

GSK Investigational Site

Cambridge, United Kingdom, CB2 0QQ

Actively Recruiting

81

GSK Investigational Site

London, United Kingdom, NW12BU

Actively Recruiting

82

GSK Investigational Site

London, United Kingdom, SW3 6JJ

Actively Recruiting

83

GSK Investigational Site

Manchester, United Kingdom, M20 4BX

Actively Recruiting

84

GSK Investigational Site

Sheffield, United Kingdom, S10 2SE

Actively Recruiting

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Research Team

U

US GSK Clinical Trials Call Center

CONTACT

E

EU GSK Clinical Trials Call Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy | DecenTrialz