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Hepatocellular CarcinomaPhase 4HATTNCT01098760

Hepatocellular Carcinoma - Advanced Stage - Sorafenib Trial in Taiwanese Patients

A Phase 4 study testing Sorafenib (Nexavar, BAY43-9006) Sorafenib (Nexavar, BAY43-9006) + Nerison Fatty Ointment Sorafenib (Nexavar, BAY43-9006)+Neribas Fatty Ointment in people with Hepatocellular Carcinoma, run by Bayer at 7 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single-arm, open-label and post-authorization study to evaluate the safety and efficacy profile of sorafenib and to evaluate Child-Pugh status progression in subjects with advanced HCC treated with sorafenib in Taiwan. 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?
Sorafenib (Nexavar, BAY43-9006) Sorafenib (Nexavar, BAY43-9006) + Nerison Fatty Ointment Sorafenib (Nexavar, BAY43-9006)+Neribas Fatty Ointment
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
151 participants
Where
7 sitesTaiwan
Study dates
Aug 2010to Oct 2013
Phase
Phase 4
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

  • Histologically or cytologically documented HCC (documentation of original biopsy for diagnosis is acceptable if tumor tissue is unavailable) or clinical diagnosis by American Association for the Study of Liver Disease (AASLD) criteria in cirrhotic patients is required. For subjects without cirrhosis, histological or cytological confirmation is mandatory.
  • Unresectable advanced/or metastatic HCC not amenable to local treatment modalities
  • 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 RECIST amendment (version 1.0)
  • 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 such as surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation are eligible. Previously treated lesions will not be selected as target lesions. Local therapy must be completed at least 4 weeks prior to the baseline scan.
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  • Cirrhotic status of Child-Pugh Class A. Child-Pugh status should be calculated based on clinical findings and laboratory results during the screening period.
  • Male or female patients >/= 18 years of age
  • Patients who have a life expectancy of at least 12 weeks
  • Patients who have an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0,1 or 2
  • Resolution of all acute toxic effects of any prior local treatment to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 grade </= 1
  • The following laboratory parameters:
  • Platelet count >/= 60 x 10^9/L
  • Hemoglobin >/= 8.5 g/dL
  • Total bilirubin </= 2.8 mg/dL
  • Alanine transaminase (ALT) and aspartate aminotransferase (AST) </= 5 x upper limit of normal
  • Serum creatinine </= 1.5 x the upper limit of normal
  • Prothrombin time-international normalized ratio (INR) </=2.3 or PT </= 6 seconds above control.
  • Patients who are being therapeutically anticoagulated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists. Close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement at pre dose, as defined by the local standard of care.

Who cannot join

  • Previous or concurrent cancer that is distinct in primary site or histology from HCC, except cervical carcinoma in situ, treated basal cell carcinoma, or superficial bladder tumors (Ta, Tis \&T1). Any cancer curatively treated > 3 years prior to entry is permitted.
  • Renal failure requiring hemo- or peritoneal dialysis.
  • History of cardiac disease:
  • Congestive heart failure > New York Heart Association (NYHA) class 2
  • Active coronary artery disease (myocardial infarction more than 6 months prior to study entry is permitted)
  • Cardiac arrhythmias requiring anti-arrhythmic therapy other than β-blockers or digoxin)
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  • Uncontrolled hypertension, defined as systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg despite optimal medical management.
  • Active, clinically serious infections (> grade 2 NCI-CTCAE, version 4.0), except HBV/HCV infections
  • Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related illness or serious acute or chronic illness
  • Known central nervous system tumors, including metastatic brain disease
  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
  • History of organ allograft
  • Child-Pugh Class B or C
  • Previous treatment with yttrium-90 spheres
  • Clinically significant (ie, symptomatic) peripheral vascular disease
  • Substance abuse or 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 agents or any agent given in association with this trial
  • Patients unable to take oral medication, requiring intravenous alimentation, who have malabsorption syndrome or any other conditions affecting gastrointestinal absorption, or who have active peptic ulcer disease
  • Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
  • Pregnant or breastfeeding patients. Women of childbearing potential must have a negative urine pregnancy test performed within 7 days prior to the start of study drug (assessed locally). Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.
  • Uncontrolled ascites (defined as not easily controlled with diuretic treatment)
  • Patients with viral diseases (eg, varicella, herpes zoster); tuberculous or syphilitic processes in the areas to be treated; and hypersensitivity to the active substances or to any of the excipients will not be included into the HFSR study subgroup.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Taiwan7 sites

  • Study site

    Chiayi City, 613

  • Study site

    Hualien County, 970

  • Study site

    Kaohsiung City, 807

  • Study site

    Kaohsiung City, 8330

  • Study site

    Taichung

  • Study site

    Taipei

  • Study site

    Taoyuan, 33305

Other trials in Taiwan

About this study

Official title: A Phase IV, Single-arm, Open-label Study of Sorafenib (Nexavar®) in Advanced Hepatocellular Carcinoma (HCC)

This is a single-arm, open-label and post-authorization study to evaluate the safety and efficacy profile of sorafenib and to evaluate Child-Pugh status progression in subjects with advanced HCC treated with sorafenib in Taiwan.

In a subgroup of patients (hand-foot skin reaction (HFSR) study subgroup), this study also aims to test if topical corticosteroids as preventive counter-measure applied to hands and feet for the first 3 weeks during sorafenib treatment reduce incidence and severity of HFSR compared to a matching, corticosteroid-free cosmetic ointment, measured over the first 3 and 6 weeks of sorafenib treatment.

Being tested
Sorafenib (Nexavar, BAY43-9006) Sorafenib (Nexavar, BAY43-9006) + Nerison Fatty Ointment Sorafenib (Nexavar, BAY43-9006)+Neribas Fatty Ointment
Keywords
Sorafenib, Hepatocellular Carcinoma (HCC)
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sorafenib (Nexavar, BAY43-9006) Sorafenib (Nexavar, BAY43-9006) + Nerison Fatty Ointment Sorafenib (Nexavar, BAY43-9006)+Neribas Fatty OintmentDrug

    Orally taken Sorafenib tablets of 400mg (2x200mg) twice daily (bid) in a continuous schedule. - For patients in Nerisone subgroup: additionally prophylactic use of Nerisone Fatty Ointment (1 g of Nerisone contains 1 mg (0.1%) diflucortolone valerate) cream for hands and feet, twice daily for 3 weeks - For patients in Neribas subgroup: additionally prophylactic use of Neribas Fatty Ointment (non-corticosteroid containing) cream for hands and feet, twice daily for 3 weeks

Study groups in NCT01098760
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: Sorafenib (Nexavar, BAY43-9006) Sorafenib (Nexavar, BAY43-9006) + Nerison Fatty Ointment Sorafenib (Nexavar, BAY43-9006)+Neribas Fatty Ointment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to progression

    Measured: 30 months

  2. Progression-free survival

    Measured: 30 months

  3. Overall survival

    Measured: 30 months

  4. Adverse event and serious adverse event (SAE) profiles

    Measured: 30 months

  5. Child-Pugh status progression

    Measured: 30 months

  6. Plasma Sorafenib exposure (AUC0-12)

    Measured: 30 months

  7. For subjects randomized into HFSR study subgroup: overall HFSR incidence in the first 3 weeks of Sorafenib treatment

    Measured: 18 months

Secondary outcomes (1)

  1. For HFSR study subgroup: a mean HFSR grade determined at the end of the first 3 weeks of sorafenib treatment.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionMar 2013
  4. Study completionOct 2013

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01098760
Sponsor's protocol ID
14898
Other IDs
HATT
Acronym
HATT
Status last verified
Oct 2013
First submitted
1 Apr 2010
Last updated
31 Oct 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sorafenib (Nexavar, BAY43-9006) Sorafenib (Nexavar, BAY43-9006) + Nerison Fatty Ointment Sorafenib (Nexavar, BAY43-9006)+Neribas Fatty Ointment in people with Hepatocellular Carcinoma, run by Bayer at 7 sites in Taiwan.

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 19 inclusion and 22 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: finished, as of the sponsor's last update on 31 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Taiwan. 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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

What does the primary outcome measure?

Time to progression (time frame: 30 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01098760.

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 31 Oct 2013.

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