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

Launched by TAIHO PHARMACEUTICAL CO., LTD. · Feb 17, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with gastrointestinal stromal tumors (GIST) who have not responded well to a medication called imatinib. The trial is divided into two parts. In the first part, researchers are trying to find the highest dose of a combination treatment using two drugs, pimitespib and imatinib, that patients can safely take without severe side effects. They will also look at how well this combination works against the tumors. The second part of the study will further evaluate the effectiveness and safety of different treatment options, including the combination therapy, pimitespib alone, and another drug called sunitinib.

To participate in this trial, patients need to be between the ages of 65 and 74, have a confirmed diagnosis of GIST, and show that their cancer has progressed after previous treatment with imatinib. Participants must be able to provide written consent and have a certain level of physical functioning. Throughout the study, participants will receive close monitoring and support from the medical team, and they will have the opportunity to contribute to important research that could help improve treatment options for future patients with GIST.

Gender

ALL

Eligibility criteria

• 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)