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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 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.

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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).

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

FieldValue
Enrollment Target 172 participants
Start Date 2010-07-09
Est. Completion 2013-09-09
Phase Phase 2

Sponsor

Daiichi Sankyo

236 total trials

What the Registry Record Tells You About NCT01033240

The ClinicalTrials.gov registry entry for NCT01033240 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 172 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 78 other Liver Cancer trials with a reported enrollment target (61% lower). The listed sponsor is Daiichi Sankyo, which has 236 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.