drugset / Trial / NCT02575339
MLN0128 Compared to Sorafenib in Advanced or Metastatic Hepatocellular Carcinoma
Phase 1/2
Terminated
11 enrolled
Kathy Miller
Big Ten Cancer Research Consortium · collabMillennium Pharmaceuticals, Inc. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is an open label, multi-center, randomized phase I/II study of MLN0128 versus standard sorafenib. Eligible subjects in the phase I trial will receive MLN0128 in escalating doses. Eligible subjects in the phase II trial will be 1:1 randomized to either the MLN0128 arm or the sorafenib arm.
Timeline
- Start
- 2016-07-18
- Primary completion
- 2018-06-26
- Completion
- 2020-11-24
Outcome
Outcome not reported
Stopped (Business): “Funder Decision”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sapanisertib | Small molecule | 15 mg | Oral |
| Subject | Sapanisertib | Small molecule | 20 mg | Oral |
| Subject | Sapanisertib | Small molecule | 30 mg | Oral |
| Comparator | Sorafenib | Small molecule | 400 mg | Oral |