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Gastrointestinal Stromal TumorsPhase 1NCT05245968

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

A Phase 1 study testing Pimitespib, Imatinib and Sunitinib in people with Gastrointestinal Stromal Tumors, run by Taiho Pharmaceutical Co., Ltd. at 14 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastrointestinal Stromal Tumors
What is being tested?
Pimitespib, Imatinib and Sunitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
14 sitesin 5 countries
Study dates
1 Dec 2021to Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provided written informed consent
  • Histologically confirmed GIST
  • Has radiographic progression based on RECIST 1.1 during or within 6 months of the last imatinib administration at enrollment. If surgery/radiotherapy has been performed, radiographic progression based on RECIST 1.1 with imatinib must have been observed after the last surgery /radiotherapy
  • Has at least one measurable lesion based on the RECIST version 1.1, except lymph nodes (not dependent on size), which should be chosen as nontarget lesions;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Who cannot join

  • Corrected visual acuity < 0.5 (using the International Visual Acuity Measurement Standard) for both eyes
  • Received treatment with any other line of therapy besides imatinib for advanced GIST
  • History of total gastrectomy and/or whole resection of the small intestine
  • 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. However, any previous cancer curatively treated > 5 years before the enrollment can be eligible
  • Pregnancy or lactation (including lactation interruption)

Trial locations and contacts

14 sites in 5 countries.

14 sites in 5 countries

Japan6 sites

  • National Cancer Center Hospital East

    Chiba

  • Hokkaido University Hospital

    Hokkaido

  • Kumamoto University Hospital

    Kumamoto

  • Osaka University Hospital

    Osaka

  • National Cancer Center Hospital

    Tokyo

  • The Cancer Institute Hospital of JFCR

    Tokyo

Other trials in Japan

Taiwan3 sites

  • Kaohsiung Medical University Hospital

    Kaohsiung City

  • Linkou Chang Gung Memorial Hospital

    Linkou District

  • Taipei Veterans General Hospital

    Taipei

Other trials in Taiwan

Australia2 sites

  • Flinders Medical Center

    Adelaide

  • Alfred Health

    Melbourne

Other trials in Australia

China2 sites

  • Beijing Cancer Hospital

    Beijing

  • Fudan University, Shanghai Cancer Center

    Shanghai

Other trials in China

Singapore1 site

  • National University Cancer Institute

    Singapore

Other trials in Singapore

About this study

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

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.

Being tested
Pimitespib, Imatinib, Sunitinib
Medical subject headings
Gastrointestinal Stromal Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PimitespibDrug

    Also called TAS-116

    Pimitespib will be administered orally in 5 consecutive days followed by 2 days off treatment (QD 5) on an empty stomach at least 1 hour before or 2 hours after a meal. The doses in the Dose Escalation Part will be 80, 120 (starting dose), and 160 mg. The doses used in Arm A will be MTD or recommended dose (RD) based on the information, including the safety and the pharmacokinetics (PK) data in the Dose Escalation Part. In Expansion Part-B, pimitespib will be administered with the starting dose of 160 mg daily.

  • ImatinibDrug

    Imatinib will be administered orally, after a meal and large glass of water QD. The doses in Dose Escalation Part will be 400 mg or 300 mg (De-escalation). The doses used in Expansion Part-A will be MTD or RD based on information, including the safety and PK data in the Dose Escalation Part. In Expansion Part-B, imatinib will be administered post after pimitespib discontinuation with the starting dose of 400 mg daily.

  • SunitinibDrug

    Sunitinib will be administered orally QD with a starting dose of 50 mg, on a schedule of 4 weeks on treatment followed by 2 weeks off, and will be taken with or without a meal in Expansion Part-C.

Study groups in NCT05245968
Study groupRoleWhat they receive
Dose Escalation PartExperimentalPimitespib in combination with imatinib
Receives: Drug: Pimitespib; Drug: Imatinib
Expansion Part-AExperimentalPimitespib in combination with imatinib
Receives: Drug: Pimitespib; Drug: Imatinib
Expansion Part-BExperimentalPimitespib followed by imatinib
Receives: Drug: Pimitespib; Drug: Imatinib
Expansion Part-CExperimentalSunitinib
Receives: Drug: Sunitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicity (DLT) of pimitespib in combination with imatinib

    Measured: At the end of Cycle 1 (each cycle is 28 days)

  2. Maximum tolerable dose (MTD) of pimitespib in combination with imatinib

    Measured: At the end of Cycle 1 (each cycle is 28 days)

  3. Progression-free survival (PFS)

    Measured: approximately 2 years

Secondary outcomes (17)

  1. Overall survival (OS)

    Measured: approximately 2 years

  2. Overall response rate (ORR)

    Measured: approximately 2 years

  3. Disease control rate (DCR)

    Measured: approximately 2 years

  4. Duration of response (DoR)

    Measured: approximately 2 years

  5. Adverse event (AE)

    Measured: approximately 2 years

  6. Adverse drug reaction (ADR)

    Measured: approximately 2 years

  7. Maximum plasma concentration (Cmax)

    Measured: Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)

  8. Time to reach maximum plasma concentration (Tmax)

    Measured: Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)

  9. Under the plasma concentration-time curve up to the last observable concentration (AUC0-last)

    Measured: Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)

  10. Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)

    Measured: Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)

  11. λz

    Measured: Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)

  12. Half-life (T1/2)

    Measured: Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)

  13. Oral clearance (CL/F)

    Measured: Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)

  14. Apparent volume of distribution (Vz/F)

    Measured: Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)

  15. Mean residence time (MRT)

    Measured: Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)

  16. Accumulation ratio

    Measured: Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)

  17. Metabolite ratio

    Measured: Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2022
  2. Study start1 Dec 2021
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05245968
Sponsor's protocol ID
10058060
Status last verified
Jan 2026
First submitted
17 Jan 2022
Last updated
20 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Taiho provides a platform for accepting researchers' requests for sharing anonymized, patient-level, analyzable datasets from articles published in peer-reviewed journals about the primary results from Taiho-sponsored interventional clinical trials in patients in which the medicine and the indication has received marketing approval from regulatory authorities in the United States, the European Union, and/or Japan on or after January 15, 2018.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pimitespib, Imatinib and Sunitinib in people with Gastrointestinal Stromal Tumors, run by Taiho Pharmaceutical Co., Ltd. at 14 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Japan, Taiwan, Australia, China, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) of pimitespib in combination with imatinib (time frame: At the end of Cycle 1 (each cycle is 28 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05245968.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.

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