check_circleStudy Completed
Carcinoma, Hepatocellular
Bayer Identifier:
10874
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
A Study to Estimate Safety and Efficacy of Sorafenib (BAY43-9006) in the Treatment of Hepatocellular Carcinoma
Trial purpose
Evaluate anti-cancer activity (e.g. proportion of patients with confirmed complete response or partial response) in patients with advanced, inoperable biopsy-proven hepatocellular carcinoma.
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
137Trial Dates
August 2002 - February 2008Phase
Phase 2Could I Receive a placebo
NoProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Hôpital de la Timone - Marseille | MARSEILLE, 13005, France |
Completed | A.O.U. Pisana | Pisa, 56126, Italy |
Completed | Hadassah University Hospital Ein Kerem | Jerusalem, 91120, Israel |
Completed | Centre Eugène Marquis - Rennes Cedex | RENNES CEDEX, 35062, France |
Completed | Ospedale Borgo Trento | Verona, 37126, Italy |
Completed | Centre Oscar Lambret - Lille | LILLE CEDEX, 59020, France |
Completed | IRCCS Osp Maggiore Policlinico | Milano, 20122, Italy |
Completed | Institut Jules Bordet/Jules Bordet Instituut | BRUXELLES - BRUSSEL, 1000, Belgium |
Completed | Centre René Gauducheau - Nantes | SAINT HERBLAIN, 44805, France |
Completed | Tel Aviv Sourasky Medical Center | Tel Aviv, 64239, Israel |
Completed | AUSL Forlì - Emilia Romagna | Forlì, 47100, Italy |
Completed | Memorial Sloan-Kettering Cancer Center | New York, 10021-6007, United States |
Completed | UZ Gent | GENT, 9000, Belgium |
Completed | Kaplan Medical Center | Rehovot, 76100, Israel |
Completed | Metropolitan Hematology Oncology Medical Group | Los Angeles, 90057, United States |
Completed | Hôpital Erasme/Erasmus Ziekenhuis | BRUXELLES - BRUSSEL, 1070, Belgium |
Completed | UZ Brussel | BRUXELLES - BRUSSEL, 1090, Belgium |
Completed | Chaim Sheba Medical Center | Tel Hashomer, 52621, Israel |
Completed | UZ Leuven Gasthuisberg | LEUVEN, 3000, Belgium |
Completed | Hôpital Tenon - Paris | PARIS, 75020, France |
Completed | Rabin Medical Center - Beilinson Campus | Petach Tikva, 49100, Israel |
Completed | IRCCS Ist Clinico Humanitas | Rozzano, 20089, Italy |
Completed | Rambam Medical Center | Haifa, 31096, Israel |
Primary Outcome
- Percentage of Participants for Each Type of Responsedate_rangeTime Frame:Until 30 days after termination of active therapyenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Duration of Responsedate_rangeTime Frame:up to 3 years laterenhanced_encryptionNoSafety Issue:
- Time to Responsedate_rangeTime Frame:up to 3 years laterenhanced_encryptionNoSafety Issue:
- Time to Progressiondate_rangeTime Frame:up to 3 years laterenhanced_encryptionNoSafety Issue:
- Duration of Stable Diseasedate_rangeTime Frame:up to 3 years laterenhanced_encryptionNoSafety Issue:
- Time to Minor Responsedate_rangeTime Frame:up to 3 years laterenhanced_encryptionNoSafety Issue:
- Duration of Minor Responsedate_rangeTime Frame:Time from MR to PDenhanced_encryptionNoSafety Issue:
- Overall Survivaldate_rangeTime Frame:Start of treatment to deathenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1