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Ripretinib

Phase 2

Gastrointestinal Stromal Tumor(GIST) | Small molecule | Oncology |Zai Lab Limited|Last Updated: Apr 3, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment108

FDA Designations

No designations recorded

Clinical trial landscape

Ripretinib · 1 trial · 1 indication

Phase 2 1
NCT04633122A Study to Assess DCC-2618 and Sunitinib in Patients With Advanced GIST After Treatment With ImatinibGastrointestinal Stromal Tumor(GIST)
COMPLETED108 Analytics
PHASE2COMPLETED
A Study to Assess DCC-2618 and Sunitinib in Patients With Advanced GIST After Treatment With Imatinib
Gastrointestinal Stromal Tumor(GIST)Unlock trial analytics

Study Endpoints

Primary Endpoints

Progression-free Survival (PFS)
Approximately 12 months.

PFS is defined as the time interval from randomization to the first occurrence of progressive disease based on assessment of the independent radiology review (IRR) or death due to any causes.

Secondary Endpoints

Objective Response Rate (ORR)
Approximately 12 months.
Disease Control Rate (DCR)
Approximately 12 months.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RipretinibEXPERIMENTAL50mg/tablet,150 mg QD continuous administration, 6 weeks (42 days) for a cycle.
SunitinibACTIVE_COMPARATOR12.5mg/capsule, 50 mg QD, in 6 weeks (42 days) with 4 weeks continuous dosing followed by 2 weeks break.

Interventions

NameTypeDescription
RipretinibDRUGOral kinase inhibitor
SunitinibDRUGsecond-line therapy in GIST patients who have progressed after imatinib treatment or are intolerant to imatinib
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Male or female patients ≥18 years of age. * Histological diagnosis of advanced GIST and capability of providing tumor tissue sample (the interval between tumor tissue collection and signing of informed consent form should be less than 3 years). Otherwise, biopsy is required. *...

Countries:China
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Frequently asked questions about Ripretinib

What is Ripretinib used for in Gastrointestinal Stromal Tumor (GIST)?

Ripretinib is an investigational small molecule being studied for the treatment of advanced Gastrointestinal Stromal Tumor (GIST) in patients who have previously been treated with imatinib. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who is developing Ripretinib?

Ripretinib is being developed by Zai Lab Limited, a biopharmaceutical company traded on the NASDAQ under the ticker symbol ZLAB. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with advanced GIST.

What phase is Ripretinib in?

Ripretinib is in Phase 2 clinical development. A completed Phase 2 trial assessed the drug in patients with advanced GIST after prior treatment with imatinib. The drug remains investigational and has not received regulatory approval.

What clinical trials is Ripretinib in?

Ripretinib has been evaluated in one completed clinical trial, identified as NCT04633122. This Phase 2 study, conducted in China, enrolled 108 patients with advanced GIST who had previously received imatinib. The trial was active-controlled, comparing Ripretinib to sunitinib.

Is Ripretinib the same as DCC-2618?

Yes, Ripretinib is also known as DCC-2618. The clinical trial NCT04633122, which assessed the drug in advanced GIST, refers to it as DCC-2618. Both names refer to the same investigational small molecule being developed by Zai Lab Limited.