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JAPANESE
JRCT ID: jRCT2031260153

Registered date:25/05/2026

A domestic Phase I study of DCC-2618 in patients with gastrointestinal stromal tumor (GIST) who are refractory or intolerant to three or more prior therapies

Basic Information

Recruitment status Pending
Health condition(s) or Problem(s) studiedGastrointestinal stromal tumor that progressed after anticancer chemotherapy
Date of first enrollment01/07/2026
Target sample size10
Countries of recruitment
Study typeInterventional
Intervention(s)DCC-2618 150 mg, administered orally once daily.

Outcome(s)

Primary OutcomeSafety
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria1. 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.
Exclude criteria1. 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.

Related Information

Contact

Public contact
Name Support Desk Clinical Trial JP
Address 8-2 Kyutaromachi, 1-Chome,Chuo-ku, Osaka-shi,Osaka, JAPAN Osaka Japan 541-8564
Telephone +81-120278120
E-mail clinical_trial@ono-pharma.com
Affiliation Ono Pharmaceutical Co.,LTD.
Scientific contact
Name Yoshinori Hirashima
Address 8-2 Kyutaromachi, 1-Chome,Chuo-ku, Osaka-shi,Osaka, JAPAN Osaka Japan 541-8564
Telephone +81-120278120
E-mail clinical_trial@ono-pharma.com
Affiliation Ono Pharmaceutical Co.,LTD.