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

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Description

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.

Study Overview

Start Date
December 1, 2021
Completion Date
December 1, 2024
Enrollment
78
Date Posted
February 18, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Flinders Medical Center
Adelaide, Australia

Alfred Health
Melbourne, Australia

Beijing Cancer Hospital
Beijing, 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, Taiwan

Linkou Chang Gung Memorial Hospital
Linkou, Taiwan

Taipei Veterans General Hospital
Taipei, Taiwan

Eligibility

Minimum Age (years)
18
Eligibility Criteria
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)

Study Contact Info

Study Contact Name
Drug Information Center
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT05245968