Nexavar-Tarceva Combination Therapy for First Line Treatment of Patients Diagnosed With Hepatocellular Carcinoma (SEARCH)

May 16, 2019 updated by: Bayer

A Phase III Randomized, Placebo Controlled, Double Blind Trial of Sorafenib Plus Erlotinib vs. Sorafenib Plus Placebo as First Line Systemic Treatment for Hepatocellular Carcinoma (HCC)

This is a randomized trial to evaluate the clinical benefit of sorafenib 400 mg twice daily and erlotinib 150 mg once a day versus sorafenib 400 mg twice daily and placebo erlotinib once daily in subjects with unresectable advanced or metastatic Child-Pugh A HCC. Patients who are candidates for potentially curative intervention (i.e. surgical resection or local ablation) are not eligible for this study.

Study Overview

Status

Status

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

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.

Detailed Description

European quality of life scale (5 dimensions) (EQ-5D)

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 (Actual)

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.
732

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 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

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
    • Queensland
      • Brisbane, Queensland, Australia, 4120
      • Herston, Queensland, Australia, 4029
    • Victoria
      • Clayton, Victoria, Australia, 3168
      • Melbourne, Victoria, Australia, 3004
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
  • Austria
      • Wien, Austria, 1090
  • Belgium
      • Bruxelles - Brussel, Belgium, 1200
      • Edegem, Belgium, 2650
      • Gent, Belgium, 9000
      • Kortrijk, Belgium, 8500
      • La Louviere, Belgium, 7100
      • Leuven, Belgium, 3000
      • Liege, Belgium, 4000
  • Brazil
      • Rio de Janeiro, Brazil, 21941-913
      • Sao Paulo, Brazil, 01509-900
      • Sao Paulo, Brazil, 05403-000
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30110-090
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 05651-900
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
      • Sofia, Bulgaria, 1784
      • Varna, Bulgaria, 9002
      • Varna, Bulgaria, 9010
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
  • Chile
      • Santiago, Chile, 7601003
      • Santiago, Chile, 838-0455
  • China
      • Beijing, China, 100021
      • Beijing, China, 100071
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
  • Colombia
      • Floridablanca, Colombia
      • Medellín, Colombia
  • France
      • Bordeaux, France, 33000
      • Clichy, France, 92110
      • Creteil, France, 94010
      • La Roche Sur Yon, France, 85925
      • Lille, France, 59037
      • Lyon, France, 69004
      • Marseille, France, 13005
      • Paris, France, 75012
      • Pessac, France, 33604
      • Vandoeuvre-les-nancy, France, 54511
      • Villejuif, France, 94800
  • Germany
      • Berlin, Germany, 12200
    • Baden-Württemberg
      • Freiburg, Baden-Württemberg, Germany, 79106
      • Tübingen, Baden-Württemberg, Germany, 72076
    • Bayern
      • München, Bayern, Germany, 81675
      • Regensburg, Bayern, Germany, 93042
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45147
      • Köln, Nordrhein-Westfalen, Germany, 50937
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
    • Saarland
      • Homburg, Saarland, Germany, 66421
  • Greece
      • Athens, Greece, 115 27
      • Larissa, Greece, 41100
      • Thessaloniki, Greece, 54642
      • Thessaloniki, Greece, 546 36
  • Hong Kong
      • Hong Kong, Hong Kong
      • Shatin, Hong Kong
  • Israel
      • Beer Sheva, Israel, 8410101
      • Haifa, Israel, 3109601
      • Petah Tikva, Israel, 4941492
      • Rehovot, Israel, 7610001
      • Zrifin, Israel, 70300
  • Italy
    • Lombardia
      • Milano, Lombardia, Italy, 20089
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
      • Seoul, Korea, Republic of, 05505
      • Seoul, Korea, Republic of, 06351
      • Seoul, Korea, Republic of, 152-703
    • Gyeonggido
      • Goyang-si, Gyeonggido, Korea, Republic of, 410-769
  • New Zealand
      • Auckland, New Zealand, 1023
      • Christchurch, New Zealand, 8011
      • Wellington South, New Zealand, 6021
  • Peru
      • Lima, Peru, Lima 1
      • Lima, Peru, LIMA 34
  • Poland
      • Bydgoszcz, Poland, 85-796
      • Gdansk, Poland, 80-952
      • Gliwice, Poland, 44-101
      • Warszawa, Poland, 02-781
  • Russian Federation
      • Barnaul, Russian Federation, 656049
      • Moscow, Russian Federation, 115478
      • Nizhny Novgorod, Russian Federation, 603001
  • Singapore
      • Singapore, Singapore, 308433
      • Singapore, Singapore, 169610
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7500
  • Spain
      • Barcelona, Spain, 08036
      • Lugo, Spain, 27003
      • Madrid, Spain, 28040
      • Santander, Spain, 39008
      • Valencia, Spain, 46026
      • Valencia, Spain, 46010
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
  • Taiwan
      • Tainan, Taiwan, 736
      • Taipei, Taiwan, 112
      • Taoyuan, Taiwan, 333
  • United Kingdom
      • Glasgow, United Kingdom, G12 0YN
      • London, United Kingdom, SE5 9RS
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2SJ
  • United States
    • California
      • San Francisco, California, United States, 94115
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
    • Florida
      • Gainesville, Florida, United States, 32610
      • Miami, Florida, United States, 33136
    • Georgia
      • Atlanta, Georgia, United States, 30318
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
    • Illinois
      • Maywood, Illinois, United States, 60153-5585
    • Kansas
      • Westwood, Kansas, United States, 66205
    • Kentucky
      • Louisville, Kentucky, United States, 40202
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
    • Maryland
      • Baltimore, Maryland, United States, 21202
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
      • Boston, Massachusetts, United States, 02215-5450
      • Worcester, Massachusetts, United States, 01655
    • Michigan
      • Detroit, Michigan, United States, 48202
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
    • New York
      • New York, New York, United States, 10029
      • Rochester, New York, United States, 14642
      • Valhalla, New York, United States, 10595
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
    • Texas
      • Houston, Texas, United States, 77030
    • Washington
      • Seattle, Washington, United States, 98109-1023

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients > 18 years of age
  • Patients who have a life expectancy of at least 12 weeks
  • Patients with histological or cytologically documented HCC

  • 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 response evaluation criteria in solid tumors (RECIST)
    • The lesion has not been previously treated with local therapy
  • Patients who have an ECOG PS (Eastern Cooperative Oncology Group Performance Status) of 0 or 1
  • Cirrhotic status of Child-Pugh class A.
  • 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.

Exclusion Criteria:

  • History of cardiac disease: congestive heart failure > New York Heart Association (NYHA) class 2; active coronary artery disease (CAD); cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin), or uncontrolled hypertension. Myocardial infarction more than 6 months prior to study entry is permitted.
  • Abnormalities of the cornea based on history (e.g. dry eye syndrome, Sogren's syndrome) including congenital abnormality (e.g. Fuch's dystrophy), abnormal slit-lamp examination using a vital dye (e.g. fluorescein, Bengal-Rose), and/or an abnormal corneal sensitivity test (Schirmer test or similar tear production test).
  • History of interstitial lung disease (ILD).
  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
  • Previous treatment with yttrium-90 spheres
  • Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
  • Uncontrolled ascites (defined as not easily controlled with diuretic treatment)

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
EXPERIMENTAL: Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva)
Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
Drug: Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg twice daily
Drug: Erlotinib (Tarceva)
Erlotinib 150 mg once daily
ACTIVE_COMPARATOR: Sorafenib (Nexavar, BAY43-9006) + Placebo
Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
Drug: Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg twice daily
Drug: Placebo
Matching erlotinib placebo 150 mg once daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From randomization of the first patient until 34 months or date of death of any cause whichever came first
Overall Survival (OS) was defined as the time from date of randomization to death due to any cause.
From randomization of the first patient until 34 months or date of death of any cause whichever came first

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to Radiological Tumor Progression (TTP)
Time Frame: From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks
TTP was the time from randomization to radiological tumor progression. Participants without radiological tumor progression at the time of analysis were censored at their last date of tumor evaluation. Progressive disease (PD) was defined using Response Evaluation Criteria in Solid Tumors (RECIST version 1.0), as at least a 20% increase in the sum of longest diameter (LD) of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. Appearance of new lesions also constituted PD.
From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks
Disease Control
Time Frame: From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks
Disease control was defined as the number of participants who had a best response rating of complete response (CR), partial response (PR), or stable disease (SD) according to RECIST assessed by magnetic resonance imaging (MRI) that was confirmed at least 28 days from the first demonstration of that rating. CR: disappearance of all clinical and radiological evidence of target and non-target tumors. PR: at least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. SD: steady state of disease. Neither sufficient shrinkage for PR nor sufficient increase for PD.
From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks
Health-related Quality of Life and Utility Values as Measured by EQ-5D - Index
Time Frame: The EQ-5D was administered at the beginning of the visit prior to seeing the investigator. Questionnaires were to be completed every 6 weeks (Day 1 of each cycle) for subsequent cycles and at the end of treatment visit.
The European quality of life scale (5 dimensions) (EQ-5D) questionnaire was given to the participants at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 'no problems'; 2 'some problems'; 3 'extreme problems'). The 5 health dimensions are summarized into a single score, the EQ-5D index score. The EQ-5D index score has a range of 0 and 1 with 0 representing death and 1 representing perfect health.
The EQ-5D was administered at the beginning of the visit prior to seeing the investigator. Questionnaires were to be completed every 6 weeks (Day 1 of each cycle) for subsequent cycles and at the end of treatment visit.
Health-related Quality of Life and Utility Values as Measured by EQ-5D - VAS
Time Frame: The EQ-5D VAS was administered at the beginning of the visit prior to seeing the investigator. Questionnaires were to be completed every 6 weeks (Day 1 of each cycle) for subsequent cycles and at the end of treatment visit.
Participants indicated on a scale of 0 (worst) to 100 (best) how good or bad their health state was on that particular day.
The EQ-5D VAS was administered at the beginning of the visit prior to seeing the investigator. Questionnaires were to be completed every 6 weeks (Day 1 of each cycle) for subsequent cycles and at the end of treatment visit.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of Response
Time Frame: From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks
Duration of response - RECIST: number of days from the date that CR or PR is first documented to date that PD is first objectively documented or to death before progression. Note: the relevant date is that of the first documentation, not the confirmation date (if participant progressed or died then censored=no) or to last observation if participant did not progress or die then censored=yes note: this last observation date should be the same as that used for time to progression.
From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks
Time to Response
Time Frame: From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks
Time to response was the number of days from randomization to the date the CR or PR was documented (with confirmation) (Note: the relevant date is that of the first documentation, not the confirmation date).
From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks
Tumor Response
Time Frame: From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks
Tumor response was the proportion of participants with the best tumor response (ie, achieving either a confirmed complete response [CR] or partial response [PR], according to Response Evaluation Criteria in Solid Tumors [RECIST] criteria).
From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks

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.
Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (ACTUAL)

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.
May 21, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 17, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 23, 2018

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).
May 13, 2009

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.
May 13, 2009

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.
May 14, 2009

Study Record Updates

Last Update Posted (ACTUAL)

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.
May 30, 2019

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.
May 16, 2019

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.
May 1, 2019

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.
  • 12917
  • 2008-006021-14 (EUDRACT_NUMBER)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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