Hepatocellular CarcinomaPhase 2/3NCT00057382
T138067 Versus Doxorubicin in Chemotherapy-Naive, Unresectable, Hepatocellular Carcinoma Patients
A Phase 2/3 study testing T138067 intravenous and doxorubicin intravenous in people with Hepatocellular Carcinoma, run by Tularik at 76 sites in 11 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- T138067 intravenous and doxorubicin intravenous
- Type of treatment
- Injection or infusion
- How many people
- 750 participants
- Where
- 76 sitesin 11 countries
- Study dates
- Mar 2003to not given
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- history of central nervous system metastases or carcinomatous meningitis
- clinically apparent ascites
- major surgery within 4 weeks of study enrollment
Trial locations and contacts
76 sites in 11 countries.
76 sites in 11 countries
Russia28 sites
Arkhangelsk Redional Oncology Center, Department of Chemotherapy
Arkhangelsk, 143045
Study site
Barnaul, 656049
Cheliabinsk Regional Oncology Center
Chelyabinsk, 545087
Irkutsk Regional Oncology Center
Irkutsk, 664035
Kazan State Medical University
Kazan', 420012
Kazan Republican Oncology Clinical Center
Kazan', 420029
Krasnodar City Oncology Center
Krasnodar, 350040
Krasnoyarsk Regional Oncology Center
Krasnoyarsk, 660133
Lipetsk
Lipetsk, 398005
Blokhin Cancer Research Center
Moscow, 115478
Central Clinical Hospital of the President of the Russian Federation
Moscow, 121356
Central Clinical Hospital of the Ministry of Transport
Moscow, 129128
Novosibirks Municipal Clinical Hospital #1
Novosibirsk, 630047
Russian Academy of Medical Sciences
Obninsk, 249020
Omsk Regional Oncology Center
Omsk
Orenburg Regional Oncology Center
Orenburg, 460021
Moscow Oncology Hospital #62
P/O Stepanovskoye, 143423
Rostov Research Oncology Institute
Rostov-on-Don, 344713
Central Research Institute of Radiology of the Ministry of Health of Russian Federation
Saint Petersburg, 189646
Medical Academy of Postgraduate Education, St. Petersburg
Saint Petersburg, 193015
St. Petersburg Mechnikov State Medical Academy
Saint Petersburg, 195065
St. Petersburg Oncology Center
Saint Petersburg, 197022
Stavropol Regional Oncology Center
Stavropol, 355018
Tomsk Regional Research Institute of Oncology
Tomsk, 634028
Bashkiria Republican Oncology Center
Ufa, 450054
Voronezh Regional Clinical Oncology Center
Voronezh, 394000
Yaroslavl Regional Oncology Center
Yaroslavl, 150054
Zhitomir Regional Hospital
Zhitomir, 10002
China15 sites
Cancer Hospital of Chinese Academy of Medical Science (CAMS)
Beijing, 100021
Beijing Cancer Hospital of Peking University
Beijing, 100036
Gereral Hospital of PLA
Beijing, 100853
Chongqing Southwest Hospital
Chongqing, 400038
Cancer Center, Sun Yat-Sen Unversity
Guangzhou, Guangdong, 510060
Guangzhou Nanfang Hospital
Guangzhou, Guangdong, 510515
Queen Mary Hospital
Hong Kong, Hong Kong
Prince Wales Hosptial
Hong Kong
Nanjing Ba Yi Hospital of PLA
Nanjing, Jiangsu, 210002
The Affiliated Hospital of Medical College Qingdao University
Qingdao, 266003
Liver Cancer Institute, Zhongshan Hospital, Fudan University
Shanghai, 200032
Shanghai Changzheng Hospital
Shanghai, 200070
Taipei Veteran General Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital
Taoyuan, Taiwan
1st Affiliated Hospital of Xi An Jiao Tong University
Xi’an, Shanxi, 710061
Ukraine9 sites
Dnepropetrovsk State Medical Academy
Dnipro, 49102
Donetsk Regional Antitumor Center
Donetsk, 83092
Kiev Central Military Clinical Hospital
Kiev, 01133
Kiev Oncology Institute of Ukrainian Academy of Medical Science
Kiev, 03022
Krivorojsky City Oncology Center
Kryvyi Rih, 50048
Lvov State Medical University
Lviv, 79031
Poltava Regional Clinical Oncological Center
Poltava, 36011
Vinnitsa Regional Clinical Oncological Center
Vinnitsa, 21021
Zaporozhje State Medical Institute of Postgraduate Education
Zaporizhzhya, 69104
United States8 sites
University of Alabama
Birmingham, Alabama, 35294
UT Southwestern Medical Center - Dallas
Dallas, Texas, 75390-9125
Loyola University of Chicago
Maywood, Illinois, 60153
VA Medical Center
Miami, Florida, 33125
University of Miami
Miami, Florida, 33136
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of California at San Francisco
San Francisco, California, 94115
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
Brazil4 sites
Hospital Vera Cruz
Belo Horizonte, 30190130
Hospital Mater Dei - Departamento de Oncologia
Belo Horizonte, 30190131
Irmandade Santa Casa de Misericórdia de Porto Alegre - Unidade de Apoio à Pesquisa
Porto Alegre, 90020090
Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, 5403000
United Kingdom4 sites
Addenbrookes Hospital
Cambridge, CB2 2QQ
Royal Free Hospital
London, NW3 2QG
Hammersmith Hospital
London, W12 OH5
Christie Hospital
Manchester, M20 4BX
Poland3 sites
Katedra i Klinika Onkologii i Radioterapi Akademii Medycznej
GdaDsk, 80-211
Oddział Chemioterapii
Olsztyn, 10-228
Klinika Katedry Onkologii AM
Poznan, 61-878
Thailand2 sites
Khon Kaen University
Khon Kaen, 40002
Chiangmai University
Muang Chiangmai, 50200
About this study
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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- T138067 intravenous, doxorubicin intravenous
- Keywords
- liver cancer
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T138067 intravenousDrug
doxorubicin intravenousDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2003 (estimated)
- Study startMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 750 participants
Sponsor and investigators
- Lead sponsor
- Tularik
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mohammad Hirmand, MD, Study director, Tularik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00057382
- Sponsor's protocol ID
- T-067-010
- Status last verified
- Sep 2004
- First submitted
- 31 Mar 2003
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T138067 Versus Doxorubicin in Chemotherapy-Naive, Unresectable, Hepatocellular Carcinoma Patients
- ClinicalTrials.gov ID
- NCT00057382
- Acronym / sponsor ID
- T-067-010
- Conditions
- Hepatocellular Carcinoma
- Keywords
- liver cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 750 participants
- Lead sponsor
- TularikIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- First posted
- 2 Apr 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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%
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T138067 intravenous | Drug | – |
| doxorubicin intravenous | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Hirmand, MD study director
Tularik
76 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing T138067 intravenous and doxorubicin intravenous in people with Hepatocellular Carcinoma, run by Tularik at 76 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 76 sites in Russia, China, Ukraine, United States, Brazil and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.