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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00057382
Other study ID # T-067-010
Secondary ID
Status Terminated
Phase Phase 2/Phase 3
First received March 31, 2003
Last updated June 23, 2005
Start date March 2003

Study information

Verified date September 2004
Source Tularik
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Other known NCT identifiers
  • NCT00066287

Recruitment information / eligibility

Status Terminated
Enrollment 750
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
T138067 intravenous

doxorubicin intravenous


Locations

Country Name City State
Brazil Hospital Mater Dei - Departamento de Oncologia Belo Horizonte
Brazil Hospital Vera Cruz Belo Horizonte
Brazil Irmandade Santa Casa de Misericórdia de Porto Alegre - Unidade de Apoio à Pesquisa Porto Alegre
Brazil Hospital das Clínicas da Faculdade de Medicina da USP São Paulo
China Beijing Cancer Hospital of Peking University Beijing
China Cancer Hospital of Chinese Academy of Medical Science (CAMS) Beijing
China Gereral Hospital of PLA Beijing
China Chongqing Southwest Hospital Chongqing
China Cancer Center, Sun Yat-Sen Unversity Guangzhou Guangdong
China Guangzhou Nanfang Hospital Guangzhou Guangdong
China Prince Wales Hosptial Hong Kong
China Queen Mary Hospital Hong Kong Hong Kong
China Nanjing Ba Yi Hospital of PLA Nanjing Jiangsu
China The Affiliated Hospital of Medical College Qingdao University Qingdao
China Liver Cancer Institute, Zhongshan Hospital, Fudan University Shanghai
China Shanghai Changzheng Hospital Shanghai
China Taipei Veteran General Hospital Taipei Taiwan
China Chang Gung Memorial Hospital Tao-Yuan Taiwan
China 1st Affiliated Hospital of Xi An Jiao Tong University Xi AN Shanxi
Poland Katedra i Klinika Onkologii i Radioterapi Akademii Medycznej GdaDsk
Poland Oddzial Chemioterapii Olsztyn
Poland Klinika Katedry Onkologii AM Poznan
Puerto Rico San Juan Medical Center San Juan
Russian Federation Arkhangelsk Redional Oncology Center, Department of Chemotherapy Arkhangelsk
Russian Federation Cheliabinsk Regional Oncology Center Chelyabinsk
Russian Federation Irkutsk Regional Oncology Center Irkutsk
Russian Federation Kazan Republican Oncology Clinical Center Kazan
Russian Federation Kazan State Medical University Kazan
Russian Federation Krasnodar City Oncology Center Krasnodar
Russian Federation Krasnoyarsk Regional Oncology Center Krasnoyarsk
Russian Federation Lipetsk Lipetsk
Russian Federation Blokhin Cancer Research Center Moscow
Russian Federation Central Clinical Hospital of the Ministry of Transport Moscow
Russian Federation Central Clinical Hospital of the President of the Russian Federation Moscow
Russian Federation Novosibirks Municipal Clinical Hospital #1 Novosibirsk
Russian Federation Russian Academy of Medical Sciences Obninsk
Russian Federation Omsk Regional Oncology Center Omsk 13
Russian Federation Orenburg Regional Oncology Center Orenburg
Russian Federation Moscow Oncology Hospital #62 P/O Stepanovskoye
Russian Federation Rostov Research Oncology Institute Rostov-on-Don
Russian Federation Central Research Institute of Radiology of the Ministry of Health of Russian Federation St Petersburg
Russian Federation Medical Academy of Postgraduate Education, St. Petersburg St Petersburg
Russian Federation St. Petersburg Mechnikov State Medical Academy St Petersburg
Russian Federation St. Petersburg Oncology Center St Petersburg
Russian Federation Stavropol Regional Oncology Center Stavropol
Russian Federation Tomsk Regional Research Institute of Oncology Tomsk
Russian Federation Bashkiria Republican Oncology Center Ufa
Russian Federation Voronezh Regional Clinical Oncology Center Voronezh
Russian Federation Yaroslavl Regional Oncology Center Yaroslavl
Russian Federation Zhitomir Regional Hospital Zhitomir
Singapore National University Hospital Singapore
South Africa Eastern Cape Oncology Centre Port Elizabeth
Thailand Khon Kaen University Khon Kaen
Thailand Chiangmai University Muang Chiangmai
Ukraine Dnepropetrovsk State Medical Academy Dnepropetrovsk
Ukraine Donetsk Regional Antitumor Center Donetsk
Ukraine Kiev Central Military Clinical Hospital Kiev
Ukraine Kiev Oncology Institute of Ukrainian Academy of Medical Science Kiev
Ukraine Krivorojsky City Oncology Center Krivoy Rog
Ukraine Lvov State Medical University Lvov
Ukraine Poltava Regional Clinical Oncological Center Poltava
Ukraine Vinnitsa Regional Clinical Oncological Center Vinnitsa
Ukraine Zaporozhje State Medical Institute of Postgraduate Education Zaporozhye
United Kingdom Addenbrookes Hospital Cambridge
United Kingdom Hammersmith Hospital London
United Kingdom Royal Free Hospital London
United Kingdom Christie Hospital Manchester
United States University of Alabama Birmingham Alabama
United States UT Southwestern Medical Center - Dallas Dallas Texas
United States Loyola University of Chicago Maywood Illinois
United States University of Miami Miami Florida
United States VA Medical Center Miami Florida
United States University of Pennsylvania Philadelphia Pennsylvania
United States University of California at San Francisco San Francisco California
United States H. Lee Moffitt Cancer Center Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Tularik

Countries where clinical trial is conducted

United States,  Brazil,  China,  Poland,  Puerto Rico,  Russian Federation,  Singapore,  South Africa,  Thailand,  Ukraine,  United Kingdom, 

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