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

Part of paid clinical trials in San Francisco, California.

Sponsor
Bayer
Study ID
NCT00901901
Phase
PHASE3
Status
Completed

Conditions

  • Carcinoma, Hepatocellular

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sorafenib (Nexavar, BAY43-9006) — DRUG
    Sorafenib 400 mg twice daily
  • Erlotinib (Tarceva) — DRUG
    Erlotinib 150 mg once daily
  • Placebo — DRUG
    Matching erlotinib placebo 150 mg once daily

Study Details

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.

Key Dates

First listed
May 14, 2009
Start date
May 21, 2009
Status verified
May 2019
Primary completion
Apr 17, 2012
Completion
May 23, 2018

Study Design

Enrollment
732 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva)
    Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
  • 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)

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 ]

Locations (23)

FacilityCityStateZIPSite coordinators
-San FranciscoCalifornia94115-
-Washington D.C.District of Columbia20007-
-GainesvilleFlorida32610-
-MiamiFlorida33136-
-AtlantaGeorgia30318-
-HonoluluHawaii96817-
-MaywoodIllinois60153-5585-
-WestwoodKansas66205-
-LouisvilleKentucky40202-
-New OrleansLouisiana70112-
-BaltimoreMaryland21202-
-BostonMassachusetts02114-
-BostonMassachusetts02215-5450-
-WorcesterMassachusetts01655-
-DetroitMichigan48202-
-MinneapolisMinnesota55455-
-New YorkNew York10029-
-RochesterNew York14642-
-ValhallaNew York10595-
-CharlotteNorth Carolina28203-
-PhiladelphiaPennsylvania19107-
-HoustonTexas77030-
-SeattleWashington98109-1023-

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