Actively Recruiting
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
Eligibility Criteria
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.
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
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
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3
GSK Investigational Site
Orlando, Florida, United States, 32806
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4
GSK Investigational Site
Iowa City, Iowa, United States, 52242
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5
GSK Investigational Site
Overland Park, Kansas, United States, 66210
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6
GSK Investigational Site
Boston, Massachusetts, United States, 02114-2696
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7
GSK Investigational Site
Boston, Massachusetts, United States, 02215
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8
GSK Investigational Site
Rochester, Minnesota, United States, 55905
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9
GSK Investigational Site
Omaha, Nebraska, United States, 68130
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10
GSK Investigational Site
Lake Success, New York, United States, 11042
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11
GSK Investigational Site
New York, New York, United States, 10032
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12
GSK Investigational Site
Durham, North Carolina, United States, 27710
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13
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19106
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14
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19111
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15
GSK Investigational Site
Knoxville, Tennessee, United States, 37920
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16
GSK Investigational Site
Dallas, Texas, United States, 75246
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17
GSK Investigational Site
Houston, Texas, United States, 77030
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18
GSK Investigational Site
Tacoma, Washington, United States, 98405
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19
GSK Investigational Site
Melbourne, Victoria, Australia, 3004
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20
GSK Investigational Site
Leuven, Belgium, 3000
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21
GSK Investigational Site
Barretos, São Paulo, Brazil, 14784-400
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22
GSK Investigational Site
Porto Alegre, Brazil, 90020-090
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23
GSK Investigational Site
Recife, Brazil, 50040000
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24
GSK Investigational Site
Vitória, Brazil, 29043-260
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25
GSK Investigational Site
Toronto, Ontario, Canada, M5G 2M9
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26
GSK Investigational Site
Montreal, Quebec, Canada, H4A 3J1
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27
GSK Investigational Site
Beijing, China, 100036
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28
GSK Investigational Site
Jinan, China, 250021
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29
GSK Investigational Site
Bordeaux, France, 33076
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30
GSK Investigational Site
Lille, France, 59000
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31
GSK Investigational Site
Lyon, France, 69373
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32
GSK Investigational Site
Saint-Herblain, France, 44805
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33
GSK Investigational Site
Villejuif, France, 94805
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34
GSK Investigational Site
Berlin, Germany
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35
GSK Investigational Site
Meldola, FC, Italy, 47014
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36
GSK Investigational Site
Candiolo, Italy, 10060
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37
GSK Investigational Site
Milan, Italy, 20133
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38
GSK Investigational Site
Palermo, Italy
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39
GSK Investigational Site
Roma, Italy, 00128
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40
GSK Investigational Site
Chiba, Japan, 277-8577
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41
GSK Investigational Site
Ehime, Japan, 791-0280
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42
GSK Investigational Site
Fukuoka, Japan, 812-8582
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43
GSK Investigational Site
Hokkaido, Japan, 060-8648
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44
GSK Investigational Site
Kanagawa, Japan, 247-8533
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45
GSK Investigational Site
Kumamoto, Japan, 860-8556
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46
GSK Investigational Site
Miyagi, Japan, 980-8574
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47
GSK Investigational Site
Osaka, Japan, 565-0871
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48
GSK Investigational Site
Tokyo, Japan, 104-0045
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49
GSK Investigational Site
Tokyo, Japan, 135-8550
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50
GSK Investigational Site
Nijmegen, Netherlands, 6525 GA
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51
GSK Investigational Site
Oslo, Norway, 0379
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52
GSK Investigational Site
Kielce, Poland, 25-640
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53
GSK Investigational Site
Poznan, Poland, 60-569
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54
GSK Investigational Site
Warsaw, Poland, 02-781
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55
GSK Investigational Site
Bucharest, Romania, 013823
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56
GSK Investigational Site
Craiova, Romania, 200542
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57
GSK Investigational Site
Timișoara, Romania, 300166
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58
GSK Investigational Site
Daegu, South Korea, 41404
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59
GSK Investigational Site
Seongnam-si Gyeonggi-do, South Korea, 463 707
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60
GSK Investigational Site
Seoul, South Korea, 03080
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61
GSK Investigational Site
Seoul, South Korea, 06351
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62
GSK Investigational Site
Seoul, South Korea, 120-752
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63
GSK Investigational Site
Seoul, South Korea, 138-736
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64
GSK Investigational Site
Suwon Kyunggi-do, South Korea, 16499
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65
GSK Investigational Site
Yangsan, South Korea, 626-770
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66
GSK Investigational Site
Barcelona, Spain, 08025
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67
GSK Investigational Site
Madrid, Spain, 28007
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68
GSK Investigational Site
Madrid, Spain, 28040
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69
GSK Investigational Site
Madrid, Spain, 28040
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70
GSK Investigational Site
Oviedo, Spain, 33006
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71
GSK Investigational Site
Seville, Spain, 41013
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72
GSK Investigational Site
Valencia, Spain, 46009
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73
GSK Investigational Site
Zaragoza, Spain, 50009
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74
GSK Investigational Site
Changhua, Taiwan, 500
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75
GSK Investigational Site
Kaohsiung City, Taiwan, 807
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76
GSK Investigational Site
Kaohsiung City, Taiwan, 833
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77
GSK Investigational Site
Taipei, Taiwan, 100
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78
GSK Investigational Site
Taipei, Taiwan, 112
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79
GSK Investigational Site
Taoyuan, Taiwan, 333
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80
GSK Investigational Site
Cambridge, United Kingdom, CB2 0QQ
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81
GSK Investigational Site
London, United Kingdom, NW12BU
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82
GSK Investigational Site
London, United Kingdom, SW3 6JJ
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83
GSK Investigational Site
Manchester, United Kingdom, M20 4BX
Actively Recruiting
84
GSK Investigational Site
Sheffield, United Kingdom, S10 2SE
Actively Recruiting
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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