Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 3
GlaxoSmithKline (Voir sur ClinicalTrials)
décembre 2025
novembre 2030
14 juin 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Axel LE CESNE | 12/06/2026 14:15:06 | Contacter | ||
Critères
Tous
- 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.