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

  • End date
    Dec 11, 2023
  • participants needed
  • sponsor
    Taiho Pharmaceutical Co., Ltd.
Updated on 4 October 2022


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.

Condition Gastrointestinal Stromal Tumors
Treatment Sunitinib, Imatinib, Pimitespib
Clinical Study IdentifierNCT05245968
SponsorTaiho Pharmaceutical Co., Ltd.
Last Modified on4 October 2022


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)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

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.

Learn more

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

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note