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Carcinoma, HepatocellularPhase 3SEARCHNCT00901901

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

A Phase 3 study testing Sorafenib (Nexavar, BAY43-9006) and Erlotinib (Tarceva) in people with Carcinoma, Hepatocellular, run by Bayer at 127 sites in 26 countries.

Completed

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

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Hepatocellular
What is being tested?
Sorafenib (Nexavar, BAY43-9006) and Erlotinib (Tarceva)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
732 participants
Where
127 sitesin 26 countries
Study dates
21 May 2009to 23 May 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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
Show all 9Show fewer
  • 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.

Who cannot join

  • 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)

Trial locations and contacts

127 sites in 26 countries.

127 sites in 26 countries

United States23 sites

  • Study site

    Atlanta, Georgia, 30318

  • Study site

    Baltimore, Maryland, 21202

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Boston, Massachusetts, 02215-5450

  • Study site

    Charlotte, North Carolina, 28203

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Gainesville, Florida, 32610

  • Study site

    Honolulu, Hawaii, 96817

  • Study site

    Houston, Texas, 77030

  • Study site

    Louisville, Kentucky, 40202

  • Study site

    Maywood, Illinois, 60153-5585

  • Study site

    Miami, Florida, 33136

  • Study site

    Minneapolis, Minnesota, 55455

  • Study site

    New Orleans, Louisiana, 70112

  • Study site

    New York, New York, 10029

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Rochester, New York, 14642

  • Study site

    San Francisco, California, 94115

  • Study site

    Seattle, Washington, 98109-1023

  • Study site

    Valhalla, New York, 10595

  • Study site

    Washington D.C., District of Columbia, 20007

  • Study site

    Westwood, Kansas, 66205

  • Study site

    Worcester, Massachusetts, 01655

Other trials in United States

France11 sites

  • Study site

    Bordeaux, 33000

  • Study site

    Clichy, 92110

  • Study site

    Créteil, 94010

  • Study site

    La Roche-sur-Yon, 85925

  • Study site

    Lille, 59037

  • Study site

    Lyon, 69004

  • Study site

    Marseille, 13005

  • Study site

    Paris, 75012

  • Study site

    Pessac, 33604

  • Study site

    Vandœuvre-lès-Nancy, 54511

  • Study site

    Villejuif, 94800

Other trials in France

Germany11 sites

  • Study site

    Berlin, 12200

  • Study site

    Cologne, North Rhine-Westphalia, 50937

  • Study site

    Essen, North Rhine-Westphalia, 45147

  • Study site

    Frankfurt am Main, Hesse, 60590

  • Study site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Study site

    Hanover, Lower Saxony, 30625

  • Study site

    Homburg, Saarland, 66421

  • Study site

    Mainz, Rhineland-Palatinate, 55131

  • Study site

    München, Bavaria, 81675

  • Study site

    Regensburg, Bavaria, 93042

  • Study site

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Belgium7 sites

  • Study site

    Bruxelles - Brussel, 1200

  • Study site

    Edegem, 2650

  • Study site

    Ghent, 9000

  • Study site

    Kortrijk, 8500

  • Study site

    La Louvière, 7100

  • Study site

    Leuven, 3000

  • Study site

    Liège, 4000

Other trials in Belgium

Spain7 sites

  • Study site

    Barcelona, 08036

  • Study site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Study site

    Lugo, 27003

  • Study site

    Madrid, 28040

  • Study site

    Santander, 39008

  • Study site

    Valencia, 46010

  • Study site

    Valencia, 46026

Other trials in Spain

Australia6 sites

  • Study site

    Brisbane, Queensland, 4120

  • Study site

    Clayton, Victoria, 3168

  • Study site

    Herston, Queensland, 4029

  • Study site

    Melbourne, Victoria, 3004

  • Study site

    Nedlands, Western Australia, 6009

  • Study site

    Randwick, New South Wales, 2031

Other trials in Australia

Brazil6 sites

  • Study site

    Belo Horizonte, Minas Gerais, 30110-090

  • Study site

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Study site

    Rio de Janeiro, 21941-913

  • Study site

    São Paulo, São Paulo, 05651-900

  • Study site

    São Paulo, 01509-900

  • Study site

    São Paulo, 05403-000

Other trials in Brazil

China5 sites

  • Study site

    Beijing, 100021

  • Study site

    Beijing, 100071

  • Study site

    Guangzhou, Guangdong, 510060

  • Study site

    Hangzhou, Zhejiang, 310016

  • Study site

    Nanjing, Jiangsu, 210002

Other trials in China

Israel5 sites

  • Study site

    Beersheba, 8410101

  • Study site

    Haifa, 3109601

  • Study site

    Petah Tikva, 4941492

  • Study site

    Rehovot, 7610001

  • Study site

    Zrifin, 70300

Other trials in Israel

South Korea5 sites

  • Study site

    Goyang-si, Gyeonggido, 410-769

  • Study site

    Seoul, 03080

  • Study site

    Seoul, 05505

  • Study site

    Seoul, 06351

  • Study site

    Seoul, 152-703

Other trials in South Korea

Bulgaria4 sites

  • Study site

    Plovdiv, 4002

  • Study site

    Sofia, 1784

  • Study site

    Varna, 9002

  • Study site

    Varna, 9010

Other trials in Bulgaria

Greece4 sites

  • Study site

    Athens, 115 27

  • Study site

    Larissa, 41100

  • Study site

    Thessaloniki, 546 36

  • Study site

    Thessaloniki, 54642

Other trials in Greece

Poland4 sites

  • Study site

    Bydgoszcz, 85-796

  • Study site

    Gdansk, 80-952

  • Study site

    Gliwice, 44-101

  • Study site

    Warsaw, 02-781

Other trials in Poland

United Kingdom4 sites

  • Study site

    Glasgow, G12 0YN

  • Study site

    London, SE5 9RS

  • Study site

    Newcastle upon Tyne, NE7 7DN

  • Study site

    Sheffield, South Yorkshire, S10 2SJ

Other trials in United Kingdom

New Zealand3 sites

  • Study site

    Auckland, 1023

  • Study site

    Christchurch, 8011

  • Study site

    Wellington South, 6021

Other trials in New Zealand

Russia3 sites

  • Study site

    Barnaul, 656049

  • Study site

    Moscow, 115478

  • Study site

    Nizhny Novgorod, 603001

Other trials in Russia

Taiwan3 sites

  • Study site

    Tainan, 736

  • Study site

    Taipei, 112

  • Study site

    Taoyuan, 333

Other trials in Taiwan

Canada2 sites

  • Study site

    Edmonton, Alberta, T6G 1Z2

  • Study site

    Montreal, Quebec, H3A 1A1

Other trials in Canada

Chile2 sites

  • Study site

    Santiago, 7601003

  • Study site

    Santiago, 838-0455

Other trials in Chile

Colombia2 sites

  • Study site

    Floridablanca

  • Study site

    Medellín

Other trials in Colombia

Hong Kong2 sites

  • Study site

    Hong Kong

  • Study site

    Shatin

Other trials in Hong Kong

Peru2 sites

  • Study site

    Lima, LIMA 1

  • Study site

    Lima, LIMA 34

Other trials in Peru

Singapore2 sites

  • Study site

    Singapore, 169610

  • Study site

    Singapore, 308433

Other trials in Singapore

South Africa2 sites

  • Study site

    Cape Town, Western Cape, 7500

  • Study site

    Johannesburg, Gauteng, 2193

Other trials in South Africa

Austria1 site

  • Study site

    Vienna, 1090

Other trials in Austria

Italy1 site

  • Study site

    Milan, Lombardy, 20089

Other trials in Italy

About this study

Official title: 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.

Read the detailed description

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

Being tested
Sorafenib (Nexavar, BAY43-9006), Erlotinib (Tarceva), Placebo
Keywords
Sorafenib (Nexavar), Erlotinib (Tarceva), First Line, 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)Drug

    Sorafenib 400 mg twice daily

  • Erlotinib (Tarceva)Drug

    Erlotinib 150 mg once daily

  • PlaceboDrug

    Matching erlotinib placebo 150 mg once daily

Study groups in NCT00901901
Study groupRoleWhat they receive
Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva)ExperimentalParticipants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
Receives: Drug: Sorafenib (Nexavar, BAY43-9006); Drug: Erlotinib (Tarceva)
Sorafenib (Nexavar, BAY43-9006) + PlaceboActive comparatorParticipants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
Receives: Drug: Sorafenib (Nexavar, BAY43-9006); Drug: Placebo

What is being measured

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

  1. Overall Survival

    Overall Survival (OS) was defined as the time from date of randomization to death due to any cause.

    Measured: From randomization of the first patient until 34 months or date of death of any cause whichever came first

Secondary outcomes (4)

  1. Time to Radiological Tumor Progression (TTP)

    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.

    Measured: From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks

  2. Disease Control

    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.

    Measured: From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks

  3. Health-related Quality of Life and Utility Values as Measured by EQ-5D - Index

    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.

    Measured: 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.

  4. Health-related Quality of Life and Utility Values as Measured by EQ-5D - VAS

    Participants indicated on a scale of 0 (worst) to 100 (best) how good or bad their health state was on that particular day.

    Measured: 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.

Timeline

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

  1. First posted14 May 2009 (estimated)
  2. Study start21 May 2009
  3. Primary completion17 Apr 2012
  4. Study completion23 May 2018

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
732 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00901901
Sponsor's protocol ID
12917
Other IDs
2008-006021-14, 2008
Acronym
SEARCH
Status last verified
May 2019
First submitted
13 May 2009
Last updated
30 May 2019
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sorafenib (Nexavar, BAY43-9006) and Erlotinib (Tarceva) in people with Carcinoma, Hepatocellular, run by Bayer at 127 sites in 26 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 9 inclusion and 7 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 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 127 sites in United States, France, Germany, Belgium, Spain and 21 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 phase mean?

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?

Yes. Results are posted in the registry (first posted 30 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overall Survival (time frame: From randomization of the first patient until 34 months or date of death of any cause whichever came first). 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 NCT00901901.

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 30 May 2019.

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