Study of DCC-2618 in Patients With GIST After at Least 3 Prior Treatments
ConditionGastrointestinal Stromal Tumors
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
DCC-2618
DrugDCC-2618 150 mg, administered orally once daily
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: DCC-2618Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse event (AE)
Time frame
Up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov