drugset / Trial / NCT02374489
A Phase II Trial of LDK378 in ROS1 and /or ALK Over-expressed Advanced Intrahepatic or Hilar Cholangiocarcinoma
Phase 2
Terminated
9 enrolled
National Health Research Institutes, Taiwan
National Cheng-Kung University Hospital · collabNational Taiwan University Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
Primary objective: To investigate the objective response rate in patients with ROS1 or ALK over-expressed locally advanced, or metastatic intrahepatic or hilar cholangiocarcinoma receiving LDK378 Secondary objectives:The progression-free survival ,The disease control rate ,The overall survival ,The toxicity profiles , The correlation between clinical outcomes and the potential predictive biomarker for tumor response
Timeline
- Start
- 2015-03
- Primary completion
- 2018-01
- Completion
- 2018-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ceritinib | Small molecule | 750 mg | Oral |