Actively Recruiting
A Phase 3, Randomized, Multicenter, Open-Label Study of IDRX-42 (GSK6042981) Versus Sunitinib in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors After Imatinib Therapy
Led by GlaxoSmithKline · Updated on 2026-05-27
450
Participants Needed
121
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new drug called IDRX-42 (also known as GSK6042981) for treating adults with Gastrointestinal Stromal Tumors (GIST) that have spread or cannot be removed by surgery. The study compares IDRX-42 to another drug, sunitinib, in participants whose cancer has progressed after treatment with imatinib. The goal is to see how well IDRX-42 works and how safe it is for these patients. Participants will be randomly assigned to receive either IDRX-42 or sunitinib. Both are given as drug treatments, and the study is open-label, meaning both participants and researchers know which treatment is given. The study will follow participants for up to approximately 130 weeks to measure progression-free survival and up to about 261 weeks for other outcomes such as overall survival, response rates, and quality of life. During the study, participants will undergo various assessments including tumor evaluations, biomarker analysis from tumor tissue samples, and safety monitoring for side effects. Researchers will track adverse events, treatment tolerability, and quality of life using questionnaires. Blood samples will be collected to measure drug levels, and participants will be followed long-term to assess treatment outcomes and safety. The total duration of participation may last over five years.
CONDITIONS
Brief 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 confirmed metastatic and/or unresectable Gastrointestinal Stromal Tumors (GIST).
- Documented disease progression or intolerance to imatinib as first-line treatment for unresectable or metastatic GIST.
- Availability of tumor tissue samples for biomarker analysis, which may come from archival tissue or a new biopsy.
You will not qualify if you...
- Known untreated or active central nervous system (brain) metastases.
- Known allergy or hypersensitivity to IDRX-42 (GSK6042981), sunitinib, or history of Stevens-Johnson syndrome from prior tyrosine kinase inhibitor treatment.
- Presence of another malignancy that has progressed or required treatment within the past 24 months, except certain skin cancers or in-situ carcinomas that have been fully treated.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 261 weeks
Participants receive either IDRX-42 or Sunitinib as treatment for gastrointestinal stromal tumors after prior imatinib therapy.
Regular visits during treatment period
Trial Site Locations
Total: 121 locations
1
GSK Investigational Site
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
GSK Investigational Site
La Jolla, California, United States, 92093
Actively Recruiting
3
GSK Investigational Site
Los Angeles, California, United States, 90048
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4
GSK Investigational Site
San Francisco, California, United States, 94158
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5
GSK Investigational Site
New Haven, Connecticut, United States, 06520
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6
GSK Investigational Site
Jacksonville, Florida, United States, 41076
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7
GSK Investigational Site
Miami, Florida, United States, 33136
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8
GSK Investigational Site
Orlando, Florida, United States, 32806
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9
GSK Investigational Site
Tampa, Florida, United States, 33612
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10
GSK Investigational Site
Iowa City, Iowa, United States, 52242
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11
GSK Investigational Site
Overland Park, Kansas, United States, 66210
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12
GSK Investigational Site
Boston, Massachusetts, United States, 02114-2696
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13
GSK Investigational Site
Boston, Massachusetts, United States, 02215
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14
GSK Investigational Site
Ann Arbor, Michigan, United States, 48109
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15
GSK Investigational Site
Rochester, Minnesota, United States, 55905
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16
GSK Investigational Site
St Louis, Missouri, United States, 63108
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17
GSK Investigational Site
Omaha, Nebraska, United States, 68130
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18
GSK Investigational Site
Lake Success, New York, United States, 11042
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19
GSK Investigational Site
New York, New York, United States, 10032
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20
GSK Investigational Site
New York, New York, United States, 10065
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21
GSK Investigational Site
Rochester, New York, United States, 14642
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22
GSK Investigational Site
Durham, North Carolina, United States, 27710
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23
GSK Investigational Site
Columbus, Ohio, United States, 43210
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24
GSK Investigational Site
Portland, Oregon, United States, 97239
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25
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19106
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26
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19111
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27
GSK Investigational Site
Spartanburg, South Carolina, United States, 29307
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28
GSK Investigational Site
Knoxville, Tennessee, United States, 37920
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29
GSK Investigational Site
Dallas, Texas, United States, 75246
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30
GSK Investigational Site
Houston, Texas, United States, 77030
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31
GSK Investigational Site
Santa Monica, Texas, United States, 90404
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32
GSK Investigational Site
Salt Lake City, Utah, United States, 84106
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33
GSK Investigational Site
Charlottesville, Virginia, United States, 22903
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34
GSK Investigational Site
Seattle, Washington, United States, 98109
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35
GSK Investigational Site
Tacoma, Washington, United States, 98405
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36
GSK Investigational Site
Garran, Australian Capital Territory, Australia, 2605
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37
GSK Investigational Site
Westmead, New South Wales, Australia, 2145
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38
GSK Investigational Site
Melbourne, Victoria, Australia, 3004
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39
GSK Investigational Site
Leuven, Belgium, 3000
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40
GSK Investigational Site
Barretos, São Paulo, Brazil, 14784-400
Actively Recruiting
41
GSK Investigational Site
São Caetano do Sul, São Paulo, Brazil, 09541-270
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42
GSK Investigational Site
Porto Alegre, Brazil, 90020-090
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43
GSK Investigational Site
Recife, Brazil, 50040000
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44
GSK Investigational Site
Vitória, Brazil, 29043-260
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45
GSK Investigational Site
Calgary, Alberta, Canada, T2N 5G2
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46
GSK Investigational Site
Toronto, Ontario, Canada, M5G 2M9
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47
GSK Investigational Site
Montreal, Quebec, Canada, H4A 3J1
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48
GSK Investigational Site
Shanghai, Shanghai Municipality, China, 201315
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49
GSK Investigational Site
Beijing, China, 100036
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50
GSK Investigational Site
Hangzhou, China, 310016
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51
GSK Investigational Site
Jinan, China, 250021
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52
GSK Investigational Site
Shanghai, China, 200127
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53
GSK Investigational Site
Wuhan, China, 430022
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54
GSK Investigational Site
Angers, France, 49055
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55
GSK Investigational Site
Bordeaux, France, 33076
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56
GSK Investigational Site
Lille, France, 59000
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57
GSK Investigational Site
Lyon, France, 69373
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58
GSK Investigational Site
Marseille, France, 13005
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59
GSK Investigational Site
Saint-Herblain, France, 44805
Actively Recruiting
60
GSK Investigational Site
Villejuif, France, 94805
Actively Recruiting
61
GSK Investigational Site
Berlin, Germany
Actively Recruiting
62
GSK Investigational Site
Essen, Germany, 45122
Actively Recruiting
63
GSK Investigational Site
Mannheim, Germany, 68167
Actively Recruiting
64
GSK Investigational Site
Meldola, FC, Italy, 47014
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65
GSK Investigational Site
Bari, Italy
Actively Recruiting
66
GSK Investigational Site
Candiolo, Italy, 10060
Actively Recruiting
67
GSK Investigational Site
Genova, Italy, 16132
Actively Recruiting
68
GSK Investigational Site
Milan, Italy, 20133
Actively Recruiting
69
GSK Investigational Site
Milan, Italy, 20141
Actively Recruiting
70
GSK Investigational Site
Palermo, Italy
Actively Recruiting
71
GSK Investigational Site
Roma, Italy, 00128
Actively Recruiting
72
GSK Investigational Site
Rozzano MI, Italy, 20089
Actively Recruiting
73
GSK Investigational Site
Chiba, Japan, 277-8577
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74
GSK Investigational Site
Ehime, Japan, 791-0280
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75
GSK Investigational Site
Fukuoka, Japan, 812-8582
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76
GSK Investigational Site
Hokkaido, Japan, 060-8648
Actively Recruiting
77
GSK Investigational Site
Kanagawa, Japan, 247-8533
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78
GSK Investigational Site
Kumamoto, Japan, 860-8556
Actively Recruiting
79
GSK Investigational Site
Miyagi, Japan, 980-8574
Actively Recruiting
80
GSK Investigational Site
Osaka, Japan, 565-0871
Actively Recruiting
81
GSK Investigational Site
Tokyo, Japan, 104-0045
Actively Recruiting
82
GSK Investigational Site
Tokyo, Japan, 135-8550
Actively Recruiting
83
GSK Investigational Site
Nijmegen, Netherlands, 6525 GA
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84
GSK Investigational Site
Oslo, Norway, 0379
Actively Recruiting
85
GSK Investigational Site
Kielce, Poland, 25-640
Actively Recruiting
86
GSK Investigational Site
Poznan, Poland, 60-569
Actively Recruiting
87
GSK Investigational Site
Warsaw, Poland, 02-781
Actively Recruiting
88
GSK Investigational Site
Bucharest, Romania, 013823
Actively Recruiting
89
GSK Investigational Site
Bucharest, Romania, 022328
Actively Recruiting
90
GSK Investigational Site
Craiova, Romania, 200542
Actively Recruiting
91
GSK Investigational Site
Timișoara, Romania, 300166
Actively Recruiting
92
GSK Investigational Site
Daegu, South Korea, 41404
Actively Recruiting
93
GSK Investigational Site
Seongnam-si Gyeonggi-do, South Korea, 463 707
Actively Recruiting
94
GSK Investigational Site
Seoul, South Korea, 03080
Actively Recruiting
95
GSK Investigational Site
Seoul, South Korea, 06351
Actively Recruiting
96
GSK Investigational Site
Seoul, South Korea, 120-752
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97
GSK Investigational Site
Seoul, South Korea, 138-736
Actively Recruiting
98
GSK Investigational Site
Suwon Kyunggi-do, South Korea, 16499
Actively Recruiting
99
GSK Investigational Site
Yangsan, South Korea, 626-770
Actively Recruiting
100
GSK Investigational Site
Barcelona, Spain, 08025
Actively Recruiting
101
GSK Investigational Site
Barcelona, Spain, 08035
Actively Recruiting
102
GSK Investigational Site
Madrid, Spain, 28007
Actively Recruiting
103
GSK Investigational Site
Madrid, Spain, 28040
Actively Recruiting
104
GSK Investigational Site
Madrid, Spain, 28040
Actively Recruiting
105
GSK Investigational Site
Oviedo, Spain, 33006
Actively Recruiting
106
GSK Investigational Site
Seville, Spain, 41013
Actively Recruiting
107
GSK Investigational Site
Valencia, Spain, 46009
Actively Recruiting
108
GSK Investigational Site
Zaragoza, Spain, 50009
Actively Recruiting
109
GSK Investigational Site
Changhua, Taiwan, 500
Actively Recruiting
110
GSK Investigational Site
Kaohsiung City, Taiwan, 807
Actively Recruiting
111
GSK Investigational Site
Kaohsiung City, Taiwan, 833
Actively Recruiting
112
GSK Investigational Site
Taipei, Taiwan, 100
Actively Recruiting
113
GSK Investigational Site
Taipei, Taiwan, 112
Actively Recruiting
114
GSK Investigational Site
Taoyuan, Taiwan, 333
Actively Recruiting
115
GSK Investigational Site
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
116
GSK Investigational Site
Edinburgh, United Kingdom, EH4 2XR
Actively Recruiting
117
GSK Investigational Site
Leeds, United Kingdom, LS9 8FF
Actively Recruiting
118
GSK Investigational Site
London, United Kingdom, NW12BU
Actively Recruiting
119
GSK Investigational Site
London, United Kingdom, SW3 6JJ
Actively Recruiting
120
GSK Investigational Site
Manchester, United Kingdom, M20 4BX
Actively Recruiting
121
GSK Investigational Site
Sheffield, United Kingdom, S10 2SE
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
E
EU GSK Clinical Trials Call Center
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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