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NCT01033240 · ClinicalTrials.gov registry record · Phase 2
CS1008- in Combination With Sorafenib Compared to Sorafenib Alone in Subjects With Advanced Liver Cancer
A Phase 2 study of Liver Cancer and Advanced Hepatocellular Carcinoma, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 2
- Development phase
- 172
- Enrollment target
- 20
- Study locations
NCT01033240: Completed Phase 2 study of Liver Cancer and Advanced Hepatocellular Carcinoma, sponsored by Daiichi Sankyo.
NCT01033240 is a Phase 2 study of Liver Cancer and Advanced Hepatocellular Carcinoma that has completed, run by Daiichi Sankyo. The registered enrollment target is 172 participants, below the 446-participant average among 78 other Liver Cancer trials with a reported enrollment target (61% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01033240, a Phase 2 study of Liver Cancer and Advanced Hepatocellular Carcinoma, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 172 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
Time to progression was defined as the time from randomization to the date of the first objective documentation of radiographic or symptomatic progression, whichever came first.
Conditions Studied
Interventions
- DRUG Sorafenib
- DRUG CS-1008 2 mg/kg
- DRUG CS-1008 6/2 mg/kg
- DRUG CS-1008 6/6 mg/kg
- DRUG CS-1008 4 mg/kg
Study Locations (20)
Other
- Chiba University Hospital - Chiba
- Okayama University Hospital - Okayama
- Osaka Med Center Cancer and Cardiovascular Disease - Osaka
- Musashino Red-Cross Hospital - Tokyo
- Keimyung University Dongsan Hospital - Daegu
- Seoul National University Hospital - Seoul
- Severance Hospital - Seoul
- Samsung Medical Center - Seoul
- Korea University Anam Hospital - Seoul
- Catholic Univ. of Korea, Seoul St. Mary's Hospital - Seoul
- Asan Medical Center - Seoul
California
- Kenmar Research Group - Los Angeles
District of Columbia
- Georgetown-Lombardi Cancer Center - Washington D.C.
New York
- The Mount Sinai Medical Center - New York
Tennessee
- Vanderbilt-Ingram Cancer Center - Nashville
Fukuoka
- Kurume University Hospital - Kurume-shi
Hiroshima
- Hiroshima University - Hiroshima
Ishikawa-ken
- Kanazawa University - Kanazawa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 172 participants |
| Start Date | 2010-07-09 |
| Est. Completion | 2013-09-09 |
| Phase | Phase 2 |
What the finished NCT01033240 record still lists
NCT01033240 is an interventional study that assigns participants to a tested intervention. The registered 172 participants enrollment target is mid-sized for trials with a published cap, below the 446-participant average among 78 other Liver Cancer trials with a reported enrollment target (61% lower).
The record links to 4 conditions, with Liver Cancer appearing as the primary indexed condition, and to 5 interventions - of which Sorafenib is the first listed.
NCT01033240 names 20 study sites across 10 states, led by Other, California, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT01033240 about?
NCT01033240 is a clinical study titled "CS1008- in Combination With Sorafenib Compared to Sorafenib Alone in Subjects With Advanced Liver Cancer". 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).
What is the current status of trial NCT01033240?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 172 participants. The study started on 2010-07-09. Estimated completion is 2013-09-09.
What conditions does trial NCT01033240 study?
This clinical trial studies the following conditions: Liver Cancer, Advanced Hepatocellular Carcinoma, Liver Neoplasms, Hepatic Cancer.
What interventions are being tested in trial NCT01033240?
The interventions under investigation include: Sorafenib (DRUG), CS-1008 2 mg/kg (DRUG), CS-1008 6/2 mg/kg (DRUG), CS-1008 6/6 mg/kg (DRUG), CS-1008 4 mg/kg (DRUG).
Who is sponsoring clinical trial NCT01033240?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01033240 being conducted?
This trial has 20 study locations across California, District of Columbia, New York, Tennessee, Fukuoka. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Liver Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01033240's enrollment target sits among peer trials
172 20th of 78 higher than 59 of 78 other Liver Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Liver Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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