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NCT01271504 · ClinicalTrials.gov registry record · Phase 1
E7050 in Combination With Sorafenib Versus Sorafenib Alone as First Line Therapy in Participants With Hepatocellular Carcinoma
A Phase 1 study of Hepatocellular Carcinoma, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 102
- Enrollment target
- 20
- Study locations
NCT01271504: Completed Phase 1 study of Hepatocellular Carcinoma, sponsored by Eisai.
NCT01271504 is a Phase 1 study of Hepatocellular Carcinoma that has completed, run by Eisai. The registered enrollment target is 102 participants, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (60% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01271504, a Phase 1 study of Hepatocellular Carcinoma, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 102 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine whether patients with hepatocellular carcinoma who receive either E7050 administered with Sorafenib or Sorafenib alone experience greater benefit (cancer responds to treatment) when E7050 is administered with Sorafenib.
Primary Outcome
DLTs were defined as clinically significant adverse events (AEs) (non-hematological, hematological and other events) occurring less than or equal to (\<=) 28 days after commencing study treatment and considered to be at least possibly or probably related to study drug by the Investigator. Toxicity will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v.4.0).
Conditions Studied
Interventions
- DRUG Sorafenib
Study Locations (20)
Other
- - Brussels
- - Brussels
- - Leuven
- - Modena
- - Pavia
- - Madrid
- - Madrid
- - Madrid
- - Madrid
- - Dnipropetrovsk
- - Donetsk
- - Kharkiv
Florida
- - Fort Myers
- - St. Petersburg
Ohio
- - Cincinnati
- - Toledo
Arizona
- - Tucson
North Carolina
- - Chapel Hill
Tennessee
- - Nashville
Milano
- - Rozzano
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2011-07-19 |
| Est. Completion | 2015-06-23 |
| Phase | Phase 1 |
What the finished NCT01271504 record still lists
NCT01271504 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (60% lower).
The record links to 1 condition, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which Sorafenib is the first listed.
NCT01271504 names 20 study sites across 7 states, led by Other, Florida, Ohio.
Frequently Asked Questions
What is clinical trial NCT01271504 about?
NCT01271504 is a clinical study titled "E7050 in Combination With Sorafenib Versus Sorafenib Alone as First Line Therapy in Participants With Hepatocellular Carcinoma". The purpose of this study is to determine whether patients with hepatocellular carcinoma who receive either E7050 administered with Sorafenib or Sorafenib alone experience greater benefit (cancer responds to treatment) when E7050 is administered with Sorafenib.
What is the current status of trial NCT01271504?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 102 participants. The study started on 2011-07-19. Estimated completion is 2015-06-23.
What conditions does trial NCT01271504 study?
This clinical trial studies the following conditions: Hepatocellular Carcinoma.
What interventions are being tested in trial NCT01271504?
The interventions under investigation include: Sorafenib (DRUG).
Who is sponsoring clinical trial NCT01271504?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01271504 being conducted?
This trial has 20 study locations across Arizona, Florida, North Carolina, Ohio, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01271504's enrollment target sits among peer trials
102 58th of 145 higher than 88 of 145 other Hepatocellular Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatocellular Carcinoma 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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