Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as DCC-2618
Ripretinib · 2 trials · 2 indications
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.
| Arm | Type | Description |
|---|---|---|
| Ripretinib | EXPERIMENTAL | 50mg/tablet,150 mg QD continuous administration, 6 weeks (42 days) for a cycle. |
| Sunitinib | ACTIVE_COMPARATOR | 12.5mg/capsule, 50 mg QD, in 6 weeks (42 days) with 4 weeks continuous dosing followed by 2 weeks break. |
| DCC-2618 | EXPERIMENTAL | DCC-2618 drug is 50mg per tablet, 150mg once a day, with 28 days as a treatment cycle. |
| Name | Type | Description |
|---|---|---|
| Ripretinib | DRUG | Oral kinase inhibitor |
| Sunitinib | DRUG | second-line therapy in GIST patients who have progressed after imatinib treatment or are intolerant to imatinib |
| DCC-2618 | DRUG | Oral kinase inhibitor |
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. *...
Ripretinib is being studied for the treatment of gastrointestinal stromal tumor, or GIST, a type of cancer that forms in the digestive tract. The clinical program described here focuses on patients with advanced GIST after prior treatment with imatinib. It is an investigational therapy in Phase 2 development.
Ripretinib targets KIT and PDGFRA, two receptor tyrosine kinases that drive tumor growth in gastrointestinal stromal tumor. It is a small molecule inhibitor designed to block these targets. Targeting KIT and PDGFRA is central to treating GIST because mutations in these kinases are common drivers of the disease.
Ripretinib is being developed by Zai Lab Limited, which trades under the ticker ZLAB. The company is running the clinical program for this asset in gastrointestinal stromal tumor.
Ripretinib is in Phase 2 clinical development for gastrointestinal stromal tumor. It is an investigational drug and has not been approved by the FDA for this use based on the information available. The Phase 2 trial in this program has been completed.
Ripretinib has been evaluated in the Phase 2 trial NCT04633122, titled a study to assess DCC-2618 and sunitinib in patients with advanced GIST after treatment with imatinib. The trial enrolled 108 patients in China, was active-controlled and randomized, and has been completed.