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Recruiting
NCT07618377
Study of DCC-2618 in Patients With GIST After at Least 3 Prior Treatments
Conditions: Gastrointestinal Stromal Tumors
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 10
Sponsor: Ono Pharmaceutical Co., Ltd.
Location: National Cancer Center Hospital East Kashiwa Chiba
Summary
To evaluate the safety of DCC-2618 in patients with unresectable, metastatic, or recurrent gastrointestinal stromal tumor (GIST) who have received three or more prior therapies
Eligibility Criteria
Inclusion Criteria:
1. Participants with a histologically confirmed diagnosis of GIST.
2. Participants who are refractory or intolerant to treatment with at least imatinib, sunitinib, and regorafenib.
3. Participants with at least one measurable lesion per the modified Response Evaluation Criteria in Solid Tumors (mRECIST) within 28 days prior to the first administration of the investigational product.
4. Participants with an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
Exclusion Criteria:
1. Participants with a concomitant or prior history of severe hypersensitivity reactions to other tyrosine kinase inhibitors.
2. Participants with uncontrolled diabetes mellitus.
3. Participants with a systemic infection requiring treatment.
Source: ClinicalTrials.gov (NCT07618377). StuddyBuddy aggregates publicly available trial information.
