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NCT02216578

Ph II CABOGIST in GIST

Completed Phase 2 Last updated 15 July 2021
What this trial tests

Phase 2 trial testing cabozantinib in Metastatic Gastrointestinal Stromal Tumor in 51 participants. Completed in 23 February 2021.

Timeline
2 February 2017
Primary endpoint
20 May 2019
23 February 2021

Quick facts

Lead sponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment51
Start date2 February 2017
Primary completion20 May 2019
Estimated completion23 February 2021
Sites11 locations across France, Belgium, United Kingdom, Germany, Hungary, Czechia

Drugs / interventions tested

Conditions studied

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC — full company profile →

Who can join

18 and older, any sex, with Metastatic Gastrointestinal Stromal Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study is a multi-center, multi-national, open label, single arm Phase II study of single-agent cabozantinib. The objective of the study is to assess the safety and activity of cabozantinib in patients with metastatic GIST who have previously progressed on imatinib and sunitinib and have not been exposed yet to other KIT- or PDGFR-directed tyrosine kinase inhibitors. Patient will receive cabozantinib until they experience no further benefit from the treatment, becoming intolerant to the drug or wishing to discontinue the treatment. Treatment beyond RECIST 1.1 progression is allowed in patients deriving clinical benefit upon investigator's discretion, provided no other criteria for treatment withdrawal are met.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Protein tyrosine kinase inhibitor resistance in malignant tumors: molecular mechanisms and future perspective.
    Yang Y, Li S, Wang Y, Zhao Y, et al · · 2022 · cited 182× · PMID 36115852 · DOI 10.1038/s41392-022-01168-8
  2. BDNF and its signaling in cancer.
    Malekan M, Nezamabadi SS, Samami E, Mohebalizadeh M, et al · · 2023 · cited 48× · PMID 36173463 · DOI 10.1007/s00432-022-04365-8
  3. Activity and safety of the multi-target tyrosine kinase inhibitor cabozantinib in patients with metastatic gastrointestinal stromal tumour after treatment with imatinib and sunitinib: European Organisation for Research and Treatment of Cancer phase II trial 1317 'CaboGIST'.
    Schöffski P, Mir O, Kasper B, Papai Z, et al · · 2020 · cited 47× · PMID 32470848 · DOI 10.1016/j.ejca.2020.04.021
  4. Advances and Challenges on Management of Gastrointestinal Stromal Tumors.
    Mei L, Du W, Idowu M, von Mehren M, et al · · 2018 · cited 35× · PMID 29868467 · DOI 10.3389/fonc.2018.00135
  5. Emerging Agents for the Treatment of Advanced, Imatinib-Resistant Gastrointestinal Stromal Tumors: Current Status and Future Directions.
    Bauer S, Joensuu H. · · 2015 · cited 27× · PMID 26187774 · DOI 10.1007/s40265-015-0440-8
  6. New frontiers in the medical management of gastrointestinal stromal tumours.
    Mazzocca A, Napolitano A, Silletta M, Spalato Ceruso M, et al · · 2019 · cited 26× · PMID 31205499 · DOI 10.1177/1758835919841946
  7. The treatment landscape in thyroid cancer: a focus on cabozantinib.
    Weitzman SP, Cabanillas ME. · · 2015 · cited 24× · PMID 26316818 · DOI 10.2147/cmar.s68373
  8. Natural history and treatment efficacy in an ambispective case series of NTRK-rearranged mesenchymal tumors.
    Dufresne A, Pissaloux D, Ngo C, Penel N, et al · · 2023 · cited 11× · PMID 37054503 · DOI 10.1016/j.esmoop.2023.101202

Verify or expand the search:

Other trials of cabozantinib

Trials testing the same drug.

Other recruiting trials for Metastatic Gastrointestinal Stromal Tumor

Currently open trials in the same condition.

Other European Organisation for Research and Treatment of Cancer - EORTC trials

Trials by the same sponsor.

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Data sources for this page

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