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

Tracking Information

tart Date  ICMJEMay 2009
Estimated Primary Completion DateJuly 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2009)
Overall Survival measured via patient phone contacts after treatment is complete [ Time Frame: From the date of randomization until th date of death due to any cause ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00901901 on Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: May 13, 2009)
  • Time to Progression, response rate, duration of response, disease control rate determined by tumor measurement using MRI or CT scans [ Time Frame: Every 6 weeks during treatment ] [ Designated as safety issue: No ]
  • Health Related Quality of Life and Utility Values as measured by the EQ-5D [ Time Frame: Every 6 weeks during treatment ] [ Designated as safety issue: No ]
  • Laboratory testing [ Time Frame: Every 3 weeks during treatment ] [ Designated as safety issue: Yes ]
  • AE reporting [ Time Frame: Every 3 weeks during treatment ] [ Designated as safety issue: Yes ]
  • ECG [ Time Frame: At the start and at the completion of treatment ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: Every 3 weeks during treatment ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJENexavar-Tarceva Combination Therapy for First Line Treatment of Patients Diagnosed With Hepatocellular Carcinoma
Official Title  ICMJEA 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)
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.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJECarcinoma, Hepatocellular
Intervention  ICMJE
  • Drug: Sorafenib (Nexavar, BAY43-9006)
    Sorafenib 400 mg BID + Matching Erlotinib Placebo QD
  • Drug: Sorafenib (Nexavar, BAY43-9006) + Erlotinib, Tarceva
    Sorafenib 400 mg BID + Erlotinib 150 mg QD
Study Arms / Comparison Groups
  • Arm 1: Active Comparator
    Intervention: Drug: Sorafenib (Nexavar, BAY43-9006)
  • Arm 2: Active Comparator
    Intervention: Drug: Sorafenib (Nexavar, BAY43-9006) + Erlotinib, Tarceva

Recruitment Information

Estimated Enrollment  ICMJE700
Estimated Completion DateJuly 2011
Estimated Primary Completion DateJuly 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 RECIST
  • The lesion has not been previously treated with local therapy
  • Patients who have an ECOG PS 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)
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Bayer Clinical Trials
Contact: For trial location information (Phone Menu Options '3' or '4')(+)1-888-84 22937
Location Countries  ICMJEUnited States,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Colombia,   Czech Republic,   France,   Germany,   Greece,   Hong Kong,   Israel,   Italy,   Korea, Republic of,   New Zealand,   Peru,   Poland,   Russian Federation,   Singapore,   South Africa,   Spain,   Taiwan,   United Kingdom

Administrative Information

Responsible PartyTherapeutic Area Head, Bayer Healthcare AG
Study ID Numbers  ICMJE12917, EudraCT:2008-006021-14, SEARCH
Study Sponsor  ICMJEBayer
Collaborators  ICMJE
  • ONYX Pharmaceuticals
  • OSI Pharmaceuticals
  • Hoffmann-La Roche
Investigators  ICMJE
Study Director:Bayer Study DirectorBayer
Information Provided ByBayer