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

NCT01033240 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2021-04-08

Study results available
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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).

Conditions

Interventions

DRUG

CS-1008 2 mg/kg

On a once a week basis CS-1008 will be administered intravenously starting at 2 mg/kg.

DRUG

Sorafenib

On a daily basis, one sorafenib tablet, 400 mg, is taken orally twice a day. The total daily dose of sorafenib is 800 mg. The sorafenib tablets are taken at least 1 hour before or 2 hours after a meal.

DRUG

CS-1008 6/2 mg/kg

A 6 mg/kg loading dose of CS-1008 will be administered intravenously, followed by a 2 mg/kg/week maintenance dose on a once-a-week basis.

DRUG

CS-1008 6/6 mg/kg

A 6 mg/kg loading dose of CS-1008 will be administered intravenously, followed by a 6 mg/kg/week maintenance dose on a once-a-week basis.

DRUG

CS-1008 4 mg/kg

On a once a week basis CS-1008 will be administered intravenously at 4 mg/kg if tolerated.

DRUG

CS-1008 6 mg/kg

On a once a week basis CS-1008 will be administered intravenously at 6 mg/kg if tolerated.

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Leader · Daiichi Sankyo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-09
Primary Completion
2012-07-13
Completion
2013-09-09
FDA Drug
Yes

Countries

  • United States
  • Japan
  • South Korea
  • Taiwan

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01033240 on ClinicalTrials.gov