Trials / Completed
CompletedNCT00692770
Sorafenib as Adjuvant Treatment in the Prevention Of Recurrence of Hepatocellular Carcinoma (STORM)
A Phase III Randomized, Double-blind, Placebo-controlled Study of Sorafenib as Adjuvant Treatment for Hepatocellular Carcinoma After Surgical Resection or Local Ablation.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,114 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate efficacy and safety of sorafenib versus placebo in the adjuvant treatment of Hepatocellular Carcinoma (HCC) after potentially curative treatment (surgical resection or local ablation).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nexavar (Sorafenib, BAY43-9006) | Sorafenib 400 mg twice daily (BID) |
| DRUG | Placebo | Placebo 2 tablets twice daily (BID) |
Timeline
- Start date
- 2008-08-15
- Primary completion
- 2013-11-29
- Completion
- 2014-11-28
- First posted
- 2008-06-06
- Last updated
- 2018-08-08
- Results posted
- 2014-12-01
Locations
199 sites across 28 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, New Zealand, Portugal, Romania, Russia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT00692770. Inclusion in this directory is not an endorsement.