Trials / Completed
CompletedNCT01387555
A Phase 2b Study of Modified Vaccinia Virus to Treat Patients Advanced Liver Cancer Who Failed Sorafenib
A Phase 2b Randomized Trial of JX-594 (Vaccinia GM-CSF / TK-deactivated Virus) Plus Best Supportive Care Versus Best Supportive Care in Patients With Advanced Hepatocellular Carcinoma Who Have Failed Sorafenib Treatment
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 129 (actual)
- Sponsor
- Jennerex Biotherapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is to determine whether JX-594 (Pexa-Vec) plus best supportive care is more effective in improving survival than best supportive care in patients with advanced Hepatocellular Carcinoma (HCC) who have failed sorafenib.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | JX-594 recombinant vaccina GM-CSF | Patients will be randomised 2:1 to Arm A or Arm B and will receive 6 treatments on days 1, 8, 22, week 6, week 12, and week 18 plus best supportive care as needed. |
| OTHER | Best Supportive Care | Patients will be randomised 2:1 to Arm A or Arm B and will receive best supportive care as needed. |
Timeline
- Start date
- 2008-12-01
- Primary completion
- 2011-12-01
- Completion
- 2011-12-01
- First posted
- 2011-07-04
- Last updated
- 2015-03-11
Locations
38 sites across 7 countries: United States, Canada, France, Germany, Hong Kong, South Korea, Taiwan
Source: ClinicalTrials.gov record NCT01387555. Inclusion in this directory is not an endorsement.