drugset / Trial / NCT03305913
Regorafenib in Combination With TAS-102 in Subjects With Metastatic Colorectal Cancer Who Have Progressed After Standard Therapy
Phase 1
Completed
12 enrolled
AIO-Studien-gGmbH
Bayer · collabInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
0116-ASG REMETY is a multicenter, open-label, non-randomized, dose-escalation Phase I study evaluating the safety and anti-tumor activity of TAS-102 administered in combination with Regorafenib in patients with metastatic colorectal cancer.
Timeline
- Start
- 2017-07-31
- Primary completion
- 2018-10-31
- Completion
- 2019-04-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Regorafenib | Small molecule | 80 mg | — |
| Subject | Regorafenib | Small molecule | 120 mg | — |
| Subject | Regorafenib | Small molecule | 160 mg | — |
| Subject | TAS-102 | Small molecule | 25 mg/m2 | Oral |
| Subject | TAS-102 | Small molecule | 30 mg/m2 | Oral |
| Subject | TAS-102 | Small molecule | 35 mg/m2 | Oral |