T138067 Versus Doxorubicin in Chemotherapy-Naive, Unresectable, Hepatocellular Carcinoma Patients

June 23, 2005 updated by: Tularik
This is an international, multicenter, randomized study of intravenous T138067 versus intravenous doxorubicin in hepatocellular carcinoma (liver cancer). Patients can not have been treated before with chemotherapy and surgery is not recommended for their cancer. A total of 750 subjects will be enrolled in this study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
750

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Belo Horizonte, Brazil, 30190130
        • Hospital Vera Cruz
      • Belo Horizonte, Brazil, 30190131
        • Hospital Mater Dei - Departamento de Oncologia
      • Porto Alegre, Brazil, 90020090
        • Irmandade Santa Casa de Misericórdia de Porto Alegre - Unidade de Apoio à Pesquisa
      • São Paulo, Brazil, 5403000
        • Hospital Das Clinicas Da Faculdade De Medicina Da USP
  • China
      • Beijing, China, 100021
        • Cancer Hospital of Chinese Academy of Medical Science (CAMS)
      • Beijing, China, 100036
        • Beijing Cancer Hospital of Peking University
      • Beijing, China, 100853
        • Gereral Hospital of PLA
      • Chongqing, China, 400038
        • Chongqing Southwest Hospital
      • Hong Kong, China
        • Prince Wales Hosptial
      • Qingdao, China, 266003
        • The Affiliated Hospital of Medical College Qingdao University
      • Shanghai, China, 200032
        • Liver cancer institute, Zhongshan Hospital, Fudan University
      • Shanghai, China, 200070
        • Shanghai Changzheng Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Cancer Center, Sun Yat-Sen Unversity
      • Guangzhou, Guangdong, China, 510515
        • Guangzhou Nanfang Hospital
    • Hong Kong
      • Hong Kong, Hong Kong, China
        • Queen Mary Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Nanjing Ba Yi Hospital of PLA
    • Shanxi
      • Xi AN, Shanxi, China, 710061
        • 1st Affiliated Hospital of Xi An Jiao Tong University
    • Taiwan
      • Taipei, Taiwan, China
        • Taipei Veteran General Hospital
      • Tao-Yuan, Taiwan, China
        • Chang Gung Memorial Hospital
  • Poland
      • GdaDsk, Poland, 80-211
        • Katedra i Klinika Onkologii i Radioterapi Akademii Medycznej
      • Olsztyn, Poland, 10-228
        • Oddział Chemioterapii
      • Poznan, Poland, 61-878
        • Klinika Katedry Onkologii AM
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • San Juan Medical Center
  • Russian Federation
      • Arkhangelsk, Russian Federation, 143045
        • Arkhangelsk Redional Oncology Center, Department of Chemotherapy
      • Barnaul, Russian Federation, 656049
      • Chelyabinsk, Russian Federation, 545087
        • Cheliabinsk Regional Oncology Center
      • Irkutsk, Russian Federation, 664035
        • Irkutsk Regional Oncology Center
      • Kazan, Russian Federation, 420012
        • Kazan State Medical University
      • Kazan, Russian Federation, 420029
        • Kazan Republican Oncology Clinical Center
      • Krasnodar, Russian Federation, 350040
        • Krasnodar City Oncology Center
      • Krasnoyarsk, Russian Federation, 660133
        • Krasnoyarsk Regional Oncology Center
      • Lipetsk, Russian Federation, 398005
        • Lipetsk
      • Moscow, Russian Federation, 115478
        • Blokhin Cancer Research Center
      • Moscow, Russian Federation, 121356
        • Central Clinical Hospital of the President of the Russian Federation
      • Moscow, Russian Federation, 129128
        • Central Clinical Hospital of the Ministry of Transport
      • Novosibirsk, Russian Federation, 630047
        • Novosibirks Municipal Clinical Hospital #1
      • Obninsk, Russian Federation, 249020
        • Russian Academy of Medical Sciences
      • Omsk 13, Russian Federation
        • Omsk Regional Oncology Center
      • Orenburg, Russian Federation, 460021
        • Orenburg Regional Oncology Center
      • P/O Stepanovskoye, Russian Federation, 143423
        • Moscow Oncology Hospital #62
      • Rostov-on-Don, Russian Federation, 344713
        • Rostov Research Oncology Institute
      • St Petersburg, Russian Federation, 189646
        • Central Research Institute of Radiology of the Ministry of Health of Russian Federation
      • St Petersburg, Russian Federation, 193015
        • Medical Academy of Postgraduate Education, St. Petersburg
      • St Petersburg, Russian Federation, 195065
        • St. Petersburg Mechnikov State Medical Academy
      • St Petersburg, Russian Federation, 197022
        • St. Petersburg Oncology Center
      • Stavropol, Russian Federation, 355018
        • Stavropol Regional Oncology Center
      • Tomsk, Russian Federation, 634028
        • Tomsk Regional Research Institute of Oncology
      • Ufa, Russian Federation, 450054
        • Bashkiria Republican Oncology Center
      • Voronezh, Russian Federation, 394000
        • Voronezh Regional Clinical Oncology Center
      • Yaroslavl, Russian Federation, 150054
        • Yaroslavl Regional Oncology Center
      • Zhitomir, Russian Federation, 10002
        • Zhitomir Regional Hospital
  • Singapore
      • Singapore, Singapore, 119074
        • National University Hospital
  • South Africa
      • Port Elizabeth, South Africa
        • Eastern Cape Oncology Centre
  • Thailand
      • Khon Kaen, Thailand, 40002
        • Khon Kaen University
      • Muang Chiangmai, Thailand, 50200
        • Chiangmai University
  • Ukraine
      • Dnepropetrovsk, Ukraine, 49102
        • Dnepropetrovsk State Medical Academy
      • Donetsk, Ukraine, 83092
        • Donetsk Regional Antitumor Center
      • Kiev, Ukraine, 01133
        • Kiev Central Military Clinical Hospital
      • Kiev, Ukraine, 03022
        • Kiev Oncology Institute of Ukrainian Academy of Medical Science
      • Krivoy Rog, Ukraine, 50048
        • Krivorojsky City Oncology Center
      • Lvov, Ukraine, 79031
        • Lvov State Medical University
      • Poltava, Ukraine, 36011
        • Poltava Regional Clinical Oncological Center
      • Vinnitsa, Ukraine, 21021
        • Vinnitsa Regional Clinical Oncological Center
      • Zaporozhye, Ukraine, 69104
        • Zaporozhje State Medical Institute of Postgraduate Education
  • United Kingdom
      • Cambridge, United Kingdom, Cb2 2qq
        • Addenbrookes Hospital
      • London, United Kingdom, NW3 2QG
        • Royal Free Hospital
      • London, United Kingdom, W12 OH5
        • Hammersmith Hospital
      • Manchester, United Kingdom, M20 4BX
        • Christie Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama
    • California
      • San Francisco, California, United States, 94115
        • University of California at San Francisco
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
      • Miami, Florida, United States, 33125
        • VA Medical Center
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University of Chicago
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Texas
      • Dallas, Texas, United States, 75390-9125
        • UT Southwestern Medical Center - Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key inclusion criteria include:

  • pathologic diagnosis of unresectable HCC
  • chemotherapy-naïve for HCC
  • Child-Pugh Class A or B liver disease
  • measurable disease (i.e., at least one lesion that is at least 20 mm in one dimension) on computerized tomography (CT) scan or magnetic resonance imaging (MRI) or at least one lesion that is at least 10 mm on spiral CT scan
  • Karnofsky Performance Status of ≥ 70%
  • life expectancy of ≥ 12 weeks
  • adequate hematologic function (i.e., absolute neutrophil count [ANC] of ≥ 1500 cells/mm3, platelet count of ≥ 80,000 cells/mm3, hemoglobin of ≥ 8.5 g/dL)
  • total bilirubin of ≤ 1.5 upper limit of normal (ULN)
  • aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 5 ULN
  • serum creatinine of ≤ 2 x ULN

Key exclusion criteria include:

  • severe, concurrent disease that would make the subject inappropriate for enrollment
  • Subjects who have received prior intravenous or intra-arterial chemotherapy, chemoembolization, intratumoral ethanol injection, cryosurgery, radiofrequency ablation, or embolization for their HCC. (note: prior surgical resection, immunotherapy, hormonal therapy, radiotherapy, and/or orthotopic liver transplantation are allowed)
  • history of other cancer within the past 5 years other than adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix
  • New York Heart Association (NYHA) class III or IV heart disease or a left ventricular ejection fraction of <50% or acute anginal symptoms
  • females who are pregnant or breast-feeding
  • received any investigational agent within 4 weeks of enrollment
  • history of central nervous system metastases or carcinomatous meningitis
  • clinically apparent ascites
  • major surgery within 4 weeks of study enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tularik

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mohammad Hirmand, MD, Tularik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2003

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2003

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2003

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2003

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2005

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2005

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • T-067-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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