Study of DCC-2618 in Patients With GIST After at Least 3 Prior Treatments

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOno Pharmaceutical Co., Ltd.

About this trial

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

Qualifiers

Participants with a histologically confirmed diagnosis of GIST.

Participants who are refractory or intolerant to treatment with at least imatinib, sunitinib, and regorafenib.

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.

Participants with an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.

Disqualifiers

Participants with a concomitant or prior history of severe hypersensitivity reactions to other tyrosine kinase inhibitors.

Participants with uncontrolled diabetes mellitus.

Participants with a systemic infection requiring treatment.

Trial design

Treatments tested in this trial

  • DCC-2618

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators