Trials / Completed
CompletedNCT04282980
A Study of DCC-2618 (Ripretinib) In Patients With With Advanced Gastrointestinal Stromal Tumors (GIST)
A Multicenter Phase 2, Single-Arm Open-Label Study of DCC-2618 to Assess Efficacy, Safety, and Pharmacokinetics In Patients With Advanced Gastrointestinal Stromal Tumors Who Have Progressed On Prior Anticancer Therapies.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- Zai Lab (Shanghai) Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this trial is to evaluate the progress free survival (PFS) of DCC-2618 in patients with advanced gastrointestinal stromal tumors who have progressed with prior anticancer therapies based on independent radiologic review.
Detailed description
The primary objective of this trial is to evaluate the progress free survival (PFS) of DCC-2618 in patients with advanced gastrointestinal stromal tumors who have progressed with prior anticancer therapies based on independent radiologic review. This study enrolled 39 subjects of 9 sites in China mainland, and all enrolled subjects received DCC-2618 after enrollment as treatment. The study used EDC to collect patient data and IRT system for patient randomization, using Imaging Endpoints as the central image to evaluate the PFS.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DCC-2618 | Oral kinase inhibitor |
Timeline
- Start date
- 2020-04-23
- Primary completion
- 2021-02-26
- Completion
- 2022-08-23
- First posted
- 2020-02-25
- Last updated
- 2025-03-03
- Results posted
- 2025-03-03
Locations
9 sites across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04282980. Inclusion in this directory is not an endorsement.