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A Study to Assess DCC-2618 and Sunitinib in Patients With Advanced GIST After Treatment With Imatinib

NCT04633122 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2026-04-03

Study results available
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Summary

the primary objective of this study is to assess the efficacy (progression-free survival,PFS) of DCC-2618 (ripretinib, ZL-2307) and sunitinib in patients with advanced gastrointestinal stromal tumors after treatment with imatinib. This study will enroll approximately 98 subjects in around 18 sites in China mainland, and all subjects will be receiving DCC-2618 or Sunitinib in equal chance as treatment.

Conditions

  • Gastrointestinal Stromal Tumor(GIST)

Interventions

DRUG

Ripretinib

Oral kinase inhibitor

DRUG

Sunitinib

second-line therapy in GIST patients who have progressed after imatinib treatment or are intolerant to imatinib

Sponsors & Collaborators

  • Zai Lab (Shanghai) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-25
Primary Completion
2022-07-20
Completion
2022-07-20
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04633122 on ClinicalTrials.gov