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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: GlaxoSmithKline • ClinicalTrials.gov ID: NCT07218926

Registry updated: 2026-10-05
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Description

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. Participants whose disease worsens after receiving sunitinib in this study may cross over to receive GSK6042981, at investigator's discretion and if additional eligibility criteria are met.

Interventions

  • IDRX-42 (Drug)
    IDRX-42 will be administered.
  • Sunitinib (Drug)
    Sunitinib will be administered.

Eligibility criteria

Inclusion Criteria: * 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. * Documented mutation status of KIT and/or PDGFRA using a tissue based next-generation sequencing or polymerase chain reaction (PCR) assay. * Tumor tissue must be available for retrospective biomarker analysis. Sample may be archival or new biopsy. Exclusion Criteria: * GIST that is both KIT and PDGFRA wild-type or known to harbor an activating PDGFRA exon 18 mutation. * 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.

Conditions

Gastrointestinal Neoplasms

Locations

  • GSK Investigational Site — Phoenix, Arizona, United States
  • GSK Investigational Site — Duarte, California, United States
  • GSK Investigational Site — La Jolla, California, United States
  • GSK Investigational Site — Los Angeles, California, United States
  • GSK Investigational Site — San Francisco, California, United States
  • GSK Investigational Site — Santa Monica, California, United States
  • GSK Investigational Site — Upland, California, United States
  • GSK Investigational Site — Aurora, Colorado, United States
  • GSK Investigational Site — New Haven, Connecticut, United States
  • GSK Investigational Site — Washington D.C., District of Columbia, United States
  • GSK Investigational Site — Jacksonville, Florida, United States
  • GSK Investigational Site — Miami, Florida, United States
  • GSK Investigational Site — Orlando, Florida, United States
  • GSK Investigational Site — Tampa, Florida, United States
  • GSK Investigational Site — Chicago, Illinois, United States
  • GSK Investigational Site — Chicago, Illinois, United States
  • GSK Investigational Site — Iowa City, Iowa, United States
  • GSK Investigational Site — Overland Park, Kansas, United States
  • GSK Investigational Site — Baton Rouge, Louisiana, United States
  • GSK Investigational Site — Baltimore, Maryland, United States
  • GSK Investigational Site — Boston, Massachusetts, United States
  • GSK Investigational Site — Boston, Massachusetts, United States
  • GSK Investigational Site — Ann Arbor, Michigan, United States
  • GSK Investigational Site — Rochester, Minnesota, United States
  • GSK Investigational Site — St Louis, Missouri, United States
  • GSK Investigational Site — Omaha, Nebraska, United States
  • GSK Investigational Site — New Hyde Park, New York, United States
  • GSK Investigational Site — New York, New York, United States
  • GSK Investigational Site — New York, New York, United States
  • GSK Investigational Site — Rochester, New York, United States
  • GSK Investigational Site — Charlotte, North Carolina, United States
  • GSK Investigational Site — Durham, North Carolina, United States
  • GSK Investigational Site — Canton, Ohio, United States
  • GSK Investigational Site — Columbus, Ohio, United States
  • GSK Investigational Site — Portland, Oregon, United States
  • GSK Investigational Site — Philadelphia, Pennsylvania, United States
  • GSK Investigational Site — Philadelphia, Pennsylvania, United States
  • GSK Investigational Site — Pittsburgh, Pennsylvania, United States
  • GSK Investigational Site — Spartanburg, South Carolina, United States
  • GSK Investigational Site — Knoxville, Tennessee, United States
  • GSK Investigational Site — Dallas, Texas, United States
  • GSK Investigational Site — Houston, Texas, United States
  • GSK Investigational Site — Salt Lake City, Utah, United States
  • GSK Investigational Site — Charlottesville, Virginia, United States
  • GSK Investigational Site — Fairfax, Virginia, United States
  • GSK Investigational Site — Richmond, Virginia, United States
  • GSK Investigational Site — Seattle, Washington, United States
  • GSK Investigational Site — Tacoma, Washington, United States
  • GSK Investigational Site — Milwaukee, Wisconsin, United States
  • GSK Investigational Site — Garran, Australian Capital Territory, Australia
  • GSK Investigational Site — Camperdown, New South Wales, Australia
  • GSK Investigational Site — Westmead, New South Wales, Australia
  • GSK Investigational Site — Melbourne, Victoria, Australia
  • GSK Investigational Site — Leuven, Belgium
  • GSK Investigational Site — Barretos, São Paulo, Brazil
  • GSK Investigational Site — São Caetano do Sul, São Paulo, Brazil
  • GSK Investigational Site — Porto Alegre, Brazil
  • GSK Investigational Site — Recife, Brazil
  • GSK Investigational Site — Vitória, Brazil
  • GSK Investigational Site — Calgary, Alberta, Canada
  • GSK Investigational Site — Toronto, Ontario, Canada
  • GSK Investigational Site — Montreal, Quebec, Canada
  • GSK Investigational Site — Shijiazhuang, Hebei, China
  • GSK Investigational Site — Shanghai, Shanghai Municipality, China
  • GSK Investigational Site — Beijing, China
  • GSK Investigational Site — Chengdu, China
  • GSK Investigational Site — Chongqing, China
  • GSK Investigational Site — Guangzhou, China
  • GSK Investigational Site — Guangzhou, China
  • GSK Investigational Site — Guangzhou, China
  • GSK Investigational Site — Hangzhou, China
  • GSK Investigational Site — Hangzhou, China
  • GSK Investigational Site — Jinan, China
  • GSK Investigational Site — Shanghai, China
  • GSK Investigational Site — Wuhan, China
  • GSK Investigational Site — Zhengzhou, China
  • GSK Investigational Site — Angers, Maine-Et-Loire, France
  • GSK Investigational Site — Bordeaux, France
  • GSK Investigational Site — Lille, France
  • GSK Investigational Site — Lyon, France
  • GSK Investigational Site — Marseille, France
  • GSK Investigational Site — Saint-Herblain, France
  • GSK Investigational Site — Toulouse, France
  • GSK Investigational Site — Villejuif, France
  • GSK Investigational Site — München, Bavaria, Germany
  • GSK Investigational Site — Cologne, North Rhine-Westphalia, Germany
  • GSK Investigational Site — Essen, North Rhine-Westphalia, Germany
  • GSK Investigational Site — Dresden, Saxony, Germany
  • GSK Investigational Site — Berlin, Germany
  • GSK Investigational Site — Mannheim, Germany
  • GSK Investigational Site — Tübingen, Germany
  • GSK Investigational Site — Budapest, Hungary
  • GSK Investigational Site — Pécs, Hungary
  • GSK Investigational Site — Meldola, FC, Italy
  • GSK Investigational Site — Rozzano MI, Lombardy, Italy
  • GSK Investigational Site — Bari, Italy
  • GSK Investigational Site — Bologna, Italy
  • GSK Investigational Site — Candiolo, Italy
  • GSK Investigational Site — Genova, Italy
  • GSK Investigational Site — Milan, Italy
  • GSK Investigational Site — Milan, Italy
  • GSK Investigational Site — Padova, Italy
  • GSK Investigational Site — Palermo, Italy
  • GSK Investigational Site — Roma, Italy
  • GSK Investigational Site — Chiba, Japan
  • GSK Investigational Site — Ehime, Japan
  • GSK Investigational Site — Fukuoka, Japan
  • GSK Investigational Site — Hokkaido, Japan
  • GSK Investigational Site — Kanagawa, Japan
  • GSK Investigational Site — Kumamoto, Japan
  • GSK Investigational Site — Miyagi, Japan
  • GSK Investigational Site — Osaka, Japan
  • GSK Investigational Site — Tokyo, Japan
  • GSK Investigational Site — Tokyo, Japan
  • GSK Investigational Site — Amsterdam, Netherlands
  • GSK Investigational Site — Leiden, Netherlands
  • GSK Investigational Site — Nijmegen, Netherlands
  • GSK Investigational Site — Rotterdam, Netherlands
  • GSK Investigational Site — Oslo, Norway
  • GSK Investigational Site — Kielce, Poland
  • GSK Investigational Site — Poznan, Poland
  • GSK Investigational Site — Warsaw, Poland
  • GSK Investigational Site — Bucharest, Romania
  • GSK Investigational Site — Bucharest, Romania
  • GSK Investigational Site — Craiova, Romania
  • GSK Investigational Site — Timișoara, Romania
  • GSK Investigational Site — Seoul, Seoul Teugbyeolsi, South Korea
  • GSK Investigational Site — Daegu, South Korea
  • GSK Investigational Site — Seongnam-si Gyeonggi-do, South Korea
  • GSK Investigational Site — Seoul, South Korea
  • GSK Investigational Site — Seoul, South Korea
  • GSK Investigational Site — Seoul, South Korea
  • GSK Investigational Site — Suwon Kyunggi-do, South Korea
  • GSK Investigational Site — Yangsan, South Korea
  • GSK Investigational Site — Barcelona, Spain
  • GSK Investigational Site — Barcelona, Spain
  • GSK Investigational Site — Madrid, Spain
  • GSK Investigational Site — Madrid, Spain
  • GSK Investigational Site — Madrid, Spain
  • GSK Investigational Site — Oviedo, Spain
  • GSK Investigational Site — Seville, Spain
  • GSK Investigational Site — Valencia, Spain
  • GSK Investigational Site — Zaragoza, Spain
  • GSK Investigational Site — Changhua, Taiwan
  • GSK Investigational Site — Kaohsiung City, Taiwan
  • GSK Investigational Site — Kaohsiung City, Taiwan
  • GSK Investigational Site — Taipei, Taiwan
  • GSK Investigational Site — Taipei, Taiwan
  • GSK Investigational Site — Taoyuan, Taiwan
  • GSK Investigational Site — Manchester, Greater Manchester, United Kingdom
  • GSK Investigational Site — Edinburgh, Midlothian, United Kingdom
  • GSK Investigational Site — Cambridge, United Kingdom
  • GSK Investigational Site — Leeds, United Kingdom
  • GSK Investigational Site — London, United Kingdom
  • GSK Investigational Site — London, United Kingdom
  • GSK Investigational Site — Sheffield, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record