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COMPLETED Phase 2

CS1008- in Combination With Sorafenib Compared to Sorafenib Alone in Subjects With Advanced Liver Cancer

NCT01033240 · View on ClinicalTrials.gov ↗

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

157 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01033240

The ClinicalTrials.gov registry entry for NCT01033240 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 172 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daiichi Sankyo, which has 157 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01033240 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, California, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01033240?

This trial is sponsored by Daiichi Sankyo, which has 157 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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