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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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25 November 2019 |
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Main ID: |
EUCTR2004-001770-40-GB |
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Date of registration:
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24/02/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A randomized controlled study of BAY 43-9006 in combination with doxorubicin versus doxorubicin in patients with advanced hepatocellular carcinoma.
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Scientific title:
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A randomized controlled study of BAY 43-9006 in combination with doxorubicin versus doxorubicin in patients with advanced hepatocellular carcinoma. |
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Date of first enrolment:
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03/06/2005 |
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Target sample size:
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90 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001770-40 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other:
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
•Male or female patients > 18 years of age
•Patients who have a life expectancy of at least 12 weeks
•Patients with advanced HCC (unresectable, and/or metastatic) which have been histologically or cytologically documented.
Patients must have at least one tumor lesion that meets both of the following criteria:
•The lesion can be accurately measured in at least one dimension according to the Response Evaluation Criteria in Solid Tumors (RECIST)
•The lesion has not been previously treated with local therapy (such as surgery, radiation therapy, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation).
•Patients who have received local therapy except chemoembolization, such as surgery, radiation therapy, hepatic arterial embolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation are eligible, provided that they either have a target lesion which has not been subjected to local therapy and/or the target lesion(s) within the field of the local therapy has shown an increase of ?25% in the size. Local therapy must be completed at least 4 weeks prior to the baseline scan.
•Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0, 1, or 2
•Cirrhotic status of Child-Pugh class A only
•Patients who are felt, by the treating investigator, to be appropriate for single agent doxorubicin treatment.
The following laboratory parameters must be met :
•Platelet count >= 75x 109/L
•Absolute neutrophil count (ANC) > 1500 /mm3
•Hemoglobin >= 8.5 g/dl
•Total bilirubin <= 3 mg/dl within 24 hours of doxorubicin treatment
•ALT and AST < 5 x the upper limit of normal
•Amylase and lipase < 1.5 x the upper limit of normal
•Serum creatinine < 1.5 x upper limit of normal
•PT-INR <=1.7. Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.
•Patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
•Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study. However cervical carcinoma in situ, treated basal cell carcinoma, melanoma in situ, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to entry is permitted.
•History of cardiac disease: congestive heart failure > class II New York Heart Assocation (NYHA); active coronary artery disease (CAD) (6 months post myocardial infarction prior to study entry); cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, or uncontrolled hypertension
•Serious myocardial dysfunction, defined as scientigraphically (MUGA, myocardial scintigram) determined absolute left ventricular ejection fraction (LVEF) below 45% or a LVEF below the normal limit
•Active clinically serious infections (> grade 2 NCI-CTCAE version 3.0)
•Known history of human immunodeficiency virus (HIV) infection
•Known CNS tumors including metastatic brain disease
•Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
•Patients with seizure disorder requiring medication (such as anti-epileptics)
•History of organ allograft
•Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results
•Known or suspected allergy to the investigational agent or any agent given in association with this trial
•Patients unable to swallow oral medications
•Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
•Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial
•Prior use of any systemic anti-cancer treatment for HCC, eg. chemotherapy, immunotherapy or hormonal therapy (except that hormonal therapy for supportive care is permitted). Antiviral treatment is allowed, however interferon therapy must be stopped at least four weeks prior to randomisation.
•Prior local chemoembolization treatment
•Prior use of Raf-kinase inhibitors (RKI), VEGF inhibitors, MEK inhibitors or Farnesyl transferase inhibitors
•Major surgery within 4 weeks of start of study drug
•Radiotherapy during study or within 3 weeks of start of study drug. [Palliative radiotherapy will be allowed as described in the Prior and Concomitant Therapy section 4.5.7]
•Use of biologic response modifiers, such as G-CSF, within 3 weeks of study entry. [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however they may not be substituted for a required dose reduction.] Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 1 month prior to the study or during the study
•Autologous bone marrow transplant or
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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advanced hepatocellular carcinoma
MedDRA version: 7.1
Level: LLT
Classification code 10049010
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Intervention(s)
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Product Name: n/a
Product Code: BAY 43-9006
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: sorafenib
Current Sponsor code: BAY 43-9006
Other descriptive name: BAY 53-9085: sorafenib tosylate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Trade Name: doxorubicin hydrochloride
Product Name: doxorubicin hydrochloride
Product Code: n/a
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: doxorubicin hydrochloride
CAS Number: 25316-40-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
INN or Proposed INN: doxorubicin hydrochloride
CAS Number: 25316-40-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
INN or Proposed INN: doxorubicin hydrochloride
CAS Number: 25316-40-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: doxorubicin hydrochloride
CAS Number: 25316-40-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
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Primary Outcome(s)
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Secondary Objective: The secondary efficacy objectives are to assess the following variables between patients treated with doxorubicin plus sorafenib versus doxorubicin plus placebo:
To evaluate
•overall survival (OS)
•Progression Free Survival (PFS)
•the overall response rate (proportion of patients with confirmed partial and complete responses as per the RECIST criteria )
To evaluate in an exploratory manner the relative TTP,TTSP,RR and overall survival between the 2 study populations
•the time to symptomatic progression (TTSP) as measured by the Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index-8 (FHSI-8)
To determine
•overall response duration and time to objective response
•overall disease control rate
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Main Objective: The primary objective is to evaluate the effect of doxorubicin plus sorafenib or doxorubicin plus placebo on time to progression (TTP) in patients with advanced hepatocellular carcinoma
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Primary end point(s): Time to progression
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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