drugset / Trial / NCT01900158
A Phase I/II Safety and Efficacy Study of PCI of Gemcitabine and Chemotherapy in Patients With Cholangiocarcinomas
SequentialOpen-labelTreatment
Summary
This is a Phase I Dose Escalation Study in which the safety, tolerability and efficacy of Amphinex®--induced Photochemical Internalisation (PCI) of Gemcitabine followed by Gemcitabine/Cisplatin Chemotherapy will be assessed in patients with advanced inoperable cholangiocarcinomas.
Timeline
- Start
- 2013-05
- Primary completion
- 2019-02
- Completion
- 2019-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fimaporfin | Other / unclassified | — | — |
| Background | Cisplatin | Other / unclassified | 25 mg/m2 | — |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | — |