A Study of Pimitespib in Combination With Imatinib in Patients With GIST (CHAPTER-GIST-101)

  • STATUS
    Recruiting
  • End date
    Dec 11, 2023
  • participants needed
    78
  • sponsor
    Taiho Pharmaceutical Co., Ltd.
Updated on 11 August 2022

Summary

This study consists of Dose escalation part and Expansion part. In Dose Escalation Part, the maximum tolerated dose of combination of pimitespib and imatinib in patients with gastrointestinal stromal tumors (GIST) who are judged to be refractory to imatinib, estimate the recommended dose, evaluate safety and pharmacokinetics, and observe the antitumor effect. Expansion part consists of 3 arms. In Arm A, the efficacy and safety will be evaluated, which of the combination of pimitespib and imatinib in patients with GIST who have failed imatinib at doses below the MTD determined in Dose Escalation Part. In Arm B, the efficacy and safety of pimitespib monotherapy will be evaluated and the therapeutic effect of imatinib administration after pimitespib will be evaluated in an exploratory manner. In Arm C, the efficacy and safety of sunitinib monotherapy will be evaluated as reference data.

Details
Condition Gastrointestinal Stromal Tumors
Treatment Sunitinib, Imatinib, Pimitespib
Clinical Study IdentifierNCT05245968
SponsorTaiho Pharmaceutical Co., Ltd.
Last Modified on11 August 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Provided written informed consent
Histologically confirmed GIST
Progressed on the basis of imaging during or within 6 months of the last imatinib administration at enrollment
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Exclusion Criteria

Received treatment with any other line of therapy besides imatinib for advanced GIST; including local surgery and radiotherapy
A serious illness or medical condition
Previous or concurrent cancer that is distinct in primary disease or histology from cancer that is being evaluated in this study
Pregnancy or lactation (including lactation interruption)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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