Status:
RECRUITING
A Study of Pimitespib in Combination With Imatinib in Patients With GIST (CHAPTER-GIST-101)
Lead Sponsor:
Taiho Pharmaceutical Co., Ltd.
Conditions:
Gastrointestinal Stromal Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT05245968
Start Date
December 1 2021
End Date
December 1 2025
Last Update
February 28 2025
Active Locations (14)
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1
Flinders Medical Center
Adelaide, Australia
2
Alfred Health
Melbourne, Australia
3
Beijing Cancer Hospital
Beijing, China
4
Fudan University, Shanghai Cancer Center
Shanghai, China