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Clinical Trials in China / NCT05245968
Active, not recruiting Phase 1

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

NCT05245968 · tracked via the Priya Life Science China tracker
Sponsor
Taiho Pharmaceutical Co., Ltd
Phase
Phase 1
Started
2021-12-01
Last updated
2026-01-20

Condition(s) studied

Gastrointestinal Stromal Tumors

Investigational drug(s) / intervention(s)

Pimitespib →Imatinib →Sunitinib →

Pimitespib: 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.

Imatinib: 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.

Sunitinib: 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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)

Primary outcome measure(s)

  • Dose-limiting toxicity (DLT) of pimitespib in combination with imatinib — At the end of Cycle 1 (each cycle is 28 days)
  • Maximum tolerable dose (MTD) of pimitespib in combination with imatinib — At the end of Cycle 1 (each cycle is 28 days)
  • Progression-free survival (PFS) — approximately 2 years

Trial sites (14)

FacilityCityRegionStatus
Flinders Medical Center Adelaide Australia
Alfred Health Melbourne Australia
Beijing Cancer Hospital Beijing China
Fudan University, Shanghai Cancer Center Shanghai China
National Cancer Center Hospital East Chiba Japan
Hokkaido University Hospital Hokkaido Japan
Kumamoto University Hospital Kumamoto Japan
Osaka University Hospital Osaka Japan
National Cancer Center Hospital Tokyo Japan
The Cancer Institute Hospital of JFCR Tokyo Japan
National University Cancer Institute Singapore Singapore
Kaohsiung Medical University Hospital Kaohsiung City Taiwan
Linkou Chang Gung Memorial Hospital Linkou District Taiwan
Taipei Veterans General Hospital Taipei Taiwan

On this site

📄 Gleevec (imatinib) drug profile →

Other trials for the same condition

Prediction of Postoperative Treatment Efficacy and Recurrence Risk of High-risk GIST Based on Liquid Biopsy MRD Recruiting
Evaluate the Efficacy and Safety of Radiotherapy Combined With Ripretinib in the Treatment of Unresectable Advanced GIST Recruiting
Avapritinib in the Treatment of Unresectable or Recurrent Metastatic GIST Non-exon18 Mutations of PDGFRA Recruiting
A Multicenter Study of Avapritinib Efficacy and Safety of Metastatic or Unresectable Gastrointestinal Stromal Tumors Recruiting
Apatinib Mesylate Versus Standard Second-line TKI in the Treatment of Advanced GIST Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05245968 on ClinicalTrials.gov ↗ ← All trials in China