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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.

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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

FieldValue
Enrollment Target 102 participants
Start Date 2011-07-19
Est. Completion 2015-06-23
Phase Phase 1
Eisai

287 total trials

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.

Similar trials for Hepatocellular Carcinoma

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 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01271504, the US trial registry maintained by the National Library of Medicine. NCT01271504 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.