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

NCT00901901 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 129172008-006021-14
• Study Type: interventional
• Target: 732
• Locations: 25 countries
• Sites: 126

Brief 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. Patients who are candidates for potentially curative intervention (i.e. surgical resection or local ablation) are not eligible for this study.

Conditions

Carcinoma, Hepatocellular

Keywords

Sorafenib (Nexavar); Erlotinib (Tarceva); First Line; HCC

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  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 Outcomes (4)

• Time to Radiological Tumor Progression (TTP)

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

• Disease Control

  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

  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

  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 Outcomes (3)

• Duration of Response

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

• Time to Response

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

• Tumor Response

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

Study Arms (2)

Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva)

EXPERIMENTAL

Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)

Drug: Sorafenib (Nexavar, BAY43-9006); Drug: Erlotinib (Tarceva)

Sorafenib (Nexavar, BAY43-9006) + Placebo

ACTIVE COMPARATOR

Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)

Drug: Sorafenib (Nexavar, BAY43-9006); Drug: Placebo

Interventions

Sorafenib (Nexavar, BAY43-9006) DRUG

Sorafenib 400 mg twice daily

Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva); Sorafenib (Nexavar, BAY43-9006) + Placebo

Erlotinib (Tarceva) DRUG

Erlotinib 150 mg once daily

Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva)

Placebo DRUG

Matching erlotinib placebo 150 mg once daily

Sorafenib (Nexavar, BAY43-9006) + Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bayer: lead

Study Sites (127)

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San Francisco, California, 94115, United States

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Washington D.C., District of Columbia, 20007, United States

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Gainesville, Florida, 32610, United States

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Miami, Florida, 33136, United States

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Atlanta, Georgia, 30318, United States

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Honolulu, Hawaii, 96817, United States

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Maywood, Illinois, 60153-5585, United States

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Westwood, Kansas, 66205, United States

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Louisville, Kentucky, 40202, United States

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New Orleans, Louisiana, 70112, United States

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Baltimore, Maryland, 21202, United States

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Boston, Massachusetts, 02114, United States

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Boston, Massachusetts, 02215-5450, United States

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Worcester, Massachusetts, 01655, United States

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Detroit, Michigan, 48202, United States

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Minneapolis, Minnesota, 55455, United States

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New York, New York, 10029, United States

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Rochester, New York, 14642, United States

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Valhalla, New York, 10595, United States

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Charlotte, North Carolina, 28203, United States

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Philadelphia, Pennsylvania, 19107, United States

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Houston, Texas, 77030, United States

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Seattle, Washington, 98109-1023, United States

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Randwick, New South Wales, 2031, Australia

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Brisbane, Queensland, 4120, Australia

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Herston, Queensland, 4029, Australia

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Clayton, Victoria, 3168, Australia

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Melbourne, Victoria, 3004, Australia

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Nedlands, Western Australia, 6009, Australia

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Vienna, 1090, Austria

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Bruxelles - Brussel, 1200, Belgium

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Edegem, 2650, Belgium

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Ghent, 9000, Belgium

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Kortrijk, 8500, Belgium

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La Louvière, 7100, Belgium

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Leuven, 3000, Belgium

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Liège, 4000, Belgium

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Belo Horizonte, Minas Gerais, 30110-090, Brazil

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Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

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São Paulo, São Paulo, 05651-900, Brazil

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Rio de Janeiro, 21941-913, Brazil

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São Paulo, 01509-900, Brazil

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São Paulo, 05403-000, Brazil

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Plovdiv, 4002, Bulgaria

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Sofia, 1784, Bulgaria

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Varna, 9002, Bulgaria

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Varna, 9010, Bulgaria

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Edmonton, Alberta, T6G 1Z2, Canada

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Montreal, Quebec, H3A 1A1, Canada

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Santiago, 7601003, Chile

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Santiago, 838-0455, Chile

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Guangzhou, Guangdong, 510060, China

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Nanjing, Jiangsu, 210002, China

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Hangzhou, Zhejiang, 310016, China

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Beijing, 100021, China

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Beijing, 100071, China

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Floridablanca, Colombia

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Medellín, Colombia

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Bordeaux, 33000, France

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Clichy, 92110, France

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Créteil, 94010, France

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La Roche-sur-Yon, 85925, France

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Lille, 59037, France

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Lyon, 69004, France

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Marseille, 13005, France

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Paris, 75012, France

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Pessac, 33604, France

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Vandœuvre-lès-Nancy, 54511, France

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Villejuif, 94800, France

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Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

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Tübingen, Baden-Wurttemberg, 72076, Germany

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München, Bavaria, 81675, Germany

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Regensburg, Bavaria, 93042, Germany

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Frankfurt am Main, Hesse, 60590, Germany

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Hanover, Lower Saxony, 30625, Germany

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Cologne, North Rhine-Westphalia, 50937, Germany

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Essen, North Rhine-Westphalia, 45147, Germany

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Mainz, Rhineland-Palatinate, 55131, Germany

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Homburg, Saarland, 66421, Germany

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Berlin, 12200, Germany

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Athens, 115 27, Greece

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Larissa, 41100, Greece

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Thessaloniki, 546 36, Greece

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Thessaloniki, 54642, Greece

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Hong Kong, Hong Kong

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Shatin, Hong Kong

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Beersheba, 8410101, Israel

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Haifa, 3109601, Israel

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Petah Tikva, 4941492, Israel

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Rehovot, 7610001, Israel

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Zrifin, 70300, Israel

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Milan, Lombardy, 20089, Italy

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Auckland, 1023, New Zealand

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Christchurch, 8011, New Zealand

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Wellington South, 6021, New Zealand

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Lima, LIMA 1, Peru

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Lima, LIMA 34, Peru

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Bydgoszcz, 85-796, Poland

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Gdansk, 80-952, Poland

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Gliwice, 44-101, Poland

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Warsaw, 02-781, Poland

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Barnaul, 656049, Russia

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Moscow, 115478, Russia

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Nizhny Novgorod, 603001, Russia

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Singapore, 169610, Singapore

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Singapore, 308433, Singapore

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Johannesburg, Gauteng, 2193, South Africa

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Cape Town, Western Cape, 7500, South Africa

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Goyang-si, Gyeonggido, 410-769, South Korea

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Seoul, 03080, South Korea

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Seoul, 05505, South Korea

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Seoul, 06351, South Korea

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Seoul, 152-703, South Korea

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L'Hospitalet de Llobregat, Barcelona, 08907, Spain

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Barcelona, 08036, Spain

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Lugo, 27003, Spain

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Madrid, 28040, Spain

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Santander, 39008, Spain

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Valencia, 46010, Spain

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Valencia, 46026, Spain

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Tainan, 736, Taiwan

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Taipei, 112, Taiwan

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Taoyuan District, 333, Taiwan

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Sheffield, South Yorkshire, S10 2SJ, United Kingdom

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Glasgow, G12 0YN, United Kingdom

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London, SE5 9RS, United Kingdom

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Newcastle upon Tyne, NE7 7DN, United Kingdom

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Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayer.com

(+)1-888-84-22937

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2009
• First Posted: May 14, 2009
• Study Start: May 21, 2009
• Primary Completion: April 17, 2012
• Study Completion: May 23, 2018
• Last Updated: May 30, 2019
• Results First Posted: September 30, 2013

Record last verified: 2019-05

Locations

BE (7); FR (11); IT (1); PL (4); CL (2); SG (2); CO (2); AU (6); TW (3); CA (2); PE (2); KR (5); US (23); ZA (2); CN (5); IL (5); RU (3); HK (2); ES (7); GR (4); GB (4); NZ (3); BR (6); DE (11); BU (4)