Trials / Completed
CompletedNCT01033240
CS1008- in Combination With Sorafenib Compared to Sorafenib Alone in Subjects With Advanced Liver Cancer
Clinical Study Protocol Phase 2, Randomized Study of CS-1008 in Combination With Sorafenib Compared to Sorafenib Alone as First-Line Systemic Therapy in Subjects With Advanced Hepatocellular Carcinoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 172 (actual)
- Sponsor
- Daiichi Sankyo · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the safety and efficacy of CS-1008 in combination with sorafenib to sorafenib alone for treating liver cancer. Approximately 160 participants will take part in this study at approximately 22 sites (4 in the US, 8 in Japan, and 10 in Asia).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CS-1008 2 mg/kg | On a once a week basis CS-1008 will be administered intravenously starting at 2 mg/kg. |
| DRUG | Sorafenib | On a daily basis, one sorafenib tablet, 400 mg, is taken orally twice a day. The total daily dose of sorafenib is 800 mg. The sorafenib tablets are taken at least 1 hour before or 2 hours after a meal. |
| DRUG | CS-1008 6/2 mg/kg | A 6 mg/kg loading dose of CS-1008 will be administered intravenously, followed by a 2 mg/kg/week maintenance dose on a once-a-week basis. |
| DRUG | CS-1008 6/6 mg/kg | A 6 mg/kg loading dose of CS-1008 will be administered intravenously, followed by a 6 mg/kg/week maintenance dose on a once-a-week basis. |
| DRUG | CS-1008 4 mg/kg | On a once a week basis CS-1008 will be administered intravenously at 4 mg/kg if tolerated. |
| DRUG | CS-1008 6 mg/kg | On a once a week basis CS-1008 will be administered intravenously at 6 mg/kg if tolerated. |
Timeline
- Start date
- 2010-07-09
- Primary completion
- 2012-07-13
- Completion
- 2013-09-09
- First posted
- 2009-12-16
- Last updated
- 2021-04-08
- Results posted
- 2021-04-08
Locations
28 sites across 4 countries: United States, Japan, South Korea, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01033240. Inclusion in this directory is not an endorsement.