DCC-2618 in GIST after at least 3 prior treatments

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase interventional study evaluates the safety of DCC-2618 in adults with unresectable, metastatic, or recurrent gastrointestinal stromal tumors who have progressed after three or more prior therapies. Participants must have at least one measurable lesion and an ECOG score of 0 or 1. Eligible patients are those who are refractory or intolerant to imatinib, sunitinib, and regorafenib. The study is conducted at two national cancer centers in Japan and is sponsored by Ono Pharmaceutical Co., Ltd. Primary focus is safety, with secondary observations potentially informing tolerability and pharmacodynamics in a heavily pretreated GIST population.

Why it matters

Who can join: the full rules

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.

Where it's running

• National Cancer Center Hospital East
  Kashiwa, Chiba, Japan Recruiting
• National Cancer Center Hospital
  Tokyo, Chuo-ku, Japan Recruiting

Study contacts

• Study coordinator: North America Clinical Trial Support Desk
• Email: clinical_trial@ono-pharma.com
• Phone: +18665877745 (Toll-Free)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.