Trials / Terminated
TerminatedNCT02489214
Donafenib Monotherapy for Previously Treated Metastatic Gastric Cancer
A Phase 1B Study of Donafenib Monotherapy for Previously Treated Metastatic Gastric Cancer
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This open-label, one-center, noncomparative, two-stage phase 1B trial assessed the donafenib in advanced gastric cancer.
Detailed description
This open-label, one-center, noncomparative, two-stage phase 1B trial assessed the tyrosine kinase inhibitor donafenib tosilate tablets (400 mg/d,200mg bid) in patients with advanced, inoperable gastric cancer progressing after chemotherapy . The primary endpoint is the safety.The secondary endpoints are tumor response and progression-free survival time.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | donafenib tosilate tablets | 200mg bid |
Timeline
- Start date
- 2016-05-16
- Primary completion
- 2019-06-13
- Completion
- 2019-06-13
- First posted
- 2015-07-02
- Last updated
- 2023-05-08
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT02489214. Inclusion in this directory is not an endorsement.