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RecruitingLast updated: 28 March 2024

CHAPTER-GIST-101: This study aims to determine the appropriate dose level, safety, and effectiveness of a combination of targeted therapies in people with gastrointestinal stromal tumours (GIST)A Phase 1 Study of TAS-116 (Pimitespib) in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumor

Clinical summary

Summary

This study consists of a Dose Escalation Part and an Expansion Part.

In the Dose Escalation Part, the maximum tolerated dose of a combination of targeted therapies, pimitespib and imatinib, will be evaluated.

Participants will receive pimitespib orally in 5 consecutive days followed by 2 days off treatment (QD5) on an empty stomach at least 1 hour before or 2 hours after a meal. The doses in this part will be 80mg, 120mg (starting dose), and 160mg). Participants will also receive imatinib orally once daily after a meal and a large glass of water. The doses in this part will be 400mg or 300mg.

The Expansion part consists of 3 arms. Eligible participants will be randomly allocated to one of these three arms. 

In Arm A, participants will receive pimitespib in combination with imatinib. Both will be administered as described in the Dose Escalation Part but the doses will be those determined in that Part of the study (the MTD or RD).

In Arm B, participants will receive pimitespib followed by imatinib. Pimitespib will be administered as described in the Dose Escalation Part, with the starting dose of 160mg daily. Imatinib will be administered orally after a meal and with a glass of water, following the discontinuation of pimitespib, starting at 400mg daily. 

In Arm C, participants will receive sunitinib, which will be administered orally once daily with a starting dose of 50mg, on a schedule of 4 weeks on treatment followed by 2 weeks off, and will be taken with or without a meal. Arm C will be evaluated as reference data. 

Conditions

This trial is treating patients with gastrointestinal stromal tumours who are judged as refractory to treatment with imatinib alone

Cancer

Sarcoma Cancers Sarcoma

Age

People18+

Phase

I

Trial Acronym

CHAPTER-GIST-101

More information

Trial Identifiers

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Trial sponsor

Taiho Pharmaceutical Co., Ltd.

Scientific Title

A Phase 1 Study of TAS-116 (Pimitespib) in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumor

Eligibility

Inclusion

  • 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

  • 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)

Inclusion

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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