drugset / Trial / NCT02564614
A Study of Hypoxia-inducible Factor 1a (HIF1A) Messenger Ribonucleic Acid (mRNA) Antagonist (RO7070179), to Demonstrate Proof-of-mechanism in Adult Participants With Hepatocellular Carcinoma (HCC)
NaSingle-groupOpen-labelTreatment
Summary
This open-label study will demonstrate proof-of-mechanism of HIF1A inhibition by a decrease of HIF1A mRNA after intravenous (IV) infusion of RO7070179 in participants with hepatocellular carcinoma (HCC) who have failed at least one line of systemic therapy. This will be a single arm study and all participants will receive RO7070179, 13 milligram per kilogram per week (mg/kg/week), 2-hour IV infusion on Days 1 and 4 during Week 1 of Cycle 1, followed by once weekly in 6 week cycle. Treatment with RO7070179 will be continued until disease progression or unacceptable toxicity.
Timeline
- Start
- 2016-05-02
- Primary completion
- 2018-01-22
- Completion
- 2018-01-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RO7070179 | Unknown | 6 mg/kg | Intravenous |
| Subject | RO7070179 | Unknown | 10 mg/kg | Intravenous |
| Subject | RO7070179 | Unknown | 13 mg/kg | Intravenous |