Estudio fase III, aleatorizado, doble ciego y controlado con placebo, de sorafenib más erlotinib frente a sorafenib más placebo como tratamiento sistémico de primera línea para el carcinoma hepatocelular.(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)) - SEARCH: Sorafenib and Erlotinib, A RAndomized TRial ProtoCol for the Treatment of Patients with Hepa

Bayer HealthCare AG, 51368 Leverkusen, Germany0 sites700 target enrollmentMay 6, 2009

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Pacientes con hepatocarcinoma celular avanzado o metastásico Child-Pugh A.(To evaluate the clinical benefit of sorafenib 400 mg twice daily and erlotibib 150 mg once a day in subjects with unresectable advanced or metastatic Child-Pugh A HCC).
Sponsor: Bayer HealthCare AG, 51368 Leverkusen, Germany
Enrollment: 700
Status: Active, not recruiting
Last Updated: 7 years ago

No summary available.

Registry

who.int

Start Date

May 6, 2009

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Bayer HealthCare AG, 51368 Leverkusen, Germany

•\* Patients with histological or cytologically documented HCC or clinical diagnosis by AASLD criteria in cirrhotic subjects is required. For subjects without cirrhosis histological confirmation is necessary.
•\* Patients must have at least one tumor lesions that meets both of the following criteria:
•\- Lesion can be accurately measured in at least one dimension according to RECIST
•\- Lesion has not been previously treated with local therapy (such as surgery, radiation therapy, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation
•\* Patients who have received local therapy are eligible. Local theapy must be completed at least 4 weeks prior to the baseline scan. Previously treated lesions will not be selected as target lesions.
•\* Patients with an ECOG PS of 0 or 1\.
•\* Cirrhotic status of Child\-Pugh Class A.
•\* Following Laboratory Parameters (as assessed by Central Laboratory):
•\- Platelet count \>\= 60 x 109/L
•\- Hemoglobin \>\= to 8\.5 g/dl

•\* Renal failure requiring hemo\- or peritoneal dialysis
•\* Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)\- related illness or serious acute or chronic illness.
•\* 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).
•\* Child\-Pugh class B or C
•\* Previous treatment with yttrium\- 90 spheres
•\* Clinically significant peripheral vascular disease
•\* 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. (See Appendix 10\.7\)
•\* History of interstitial lung disease (ILD)
•\* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
•\* Active clinically serious infections (\> grade 2 National Cancer Institute \[NCI]\-Common Terminology Criteria for Adverse Events \[CTCAE] version 3\.0\), except HBV/HCV infections