Trials / Completed
CompletedNCT04633122
A Study to Assess DCC-2618 and Sunitinib in Patients With Advanced GIST After Treatment With Imatinib
A Phase 2, Randomized, Multicenter, Open-label Study of DCC-2618 (Ripretinib, ZL-2307 ) vs Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumors After Treatment With Imatinib
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 108 (actual)
- Sponsor
- Zai Lab (Shanghai) Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ripretinib | Oral kinase inhibitor |
| DRUG | Sunitinib | second-line therapy in GIST patients who have progressed after imatinib treatment or are intolerant to imatinib |
Timeline
- Start date
- 2020-11-25
- Primary completion
- 2022-07-20
- Completion
- 2022-07-20
- First posted
- 2020-11-18
- Last updated
- 2026-04-03
- Results posted
- 2025-01-15
Locations
18 sites across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04633122. Inclusion in this directory is not an endorsement.