drugset / Trial / NCT02288078
Oral Steroids for Regorafenib-induced Fatigue/Malaise in Unresectable mCRC (KSCC1402/HGCSG1402)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The objective of this randomized placebo-controlled Phase 2 study is to evaluate prophylactic effects of dexamethasone for fatigue and malaise (weakness, lethargy, malaise) resulting from regorafenib treatment, as well as to assess treatment continuation of regorafenib.
Timeline
- Start
- 2014-10
- Primary completion
- 2015-09
- Completion
- 2016-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dexamethasone | Small molecule | 2 mg | — |
| Comparator | Regorafenib | Small molecule | 160 mg | Oral |
| Comparator | Lansoprazole | Other / unclassified | — | — |
| Comparator | Omeprazole | Other / unclassified | — | — |