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) studied | Gastrointestinal stromal tumor that progressed after anticancer chemotherapy |
| Date of first enrollment | 01/07/2026 |
| Target sample size | 10 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | DCC-2618 150 mg, administered orally once daily. |
Outcome(s)
| Primary Outcome | Safety |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | >= 18age old |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include 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. |
| Exclude 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. |
Related Information
| Primary Sponsor | Hirashima Yoshinori |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
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 |
| 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 |
| clinical_trial@ono-pharma.com | |
| Affiliation | Ono Pharmaceutical Co.,LTD. |