| March 14, 2005 |
| June 4, 2009 |
| March 2005 |
| November 2008 (final data collection date for primary outcome measure) |
| Overall Survival & Time to Symptomatic Progression [ Time Frame: Every 3 weeks ] [ Designated as safety issue: Yes ] |
| Same as current |
| Complete list of historical versions of study NCT00105443 on ClinicalTrials.gov Archive Site |
- Time to Progression [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
- Disease Control Rate [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
- Patient Reported Outcomes (PRO) as measured by total score on FACT-Hep [ Time Frame: Cycle 1 Day 1, Cycle 3 Day 1, EOT visit ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| A Phase III Randomized, Placebo-Controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma |
| A Phase III Randomized, Placebo-Controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma |
The purpose of the study is: Find out if patients receiving sorafenib will live longer. Find out if sorafenib has any effect on patient reported outcomes. Find out if sorafenib prevents the growth of or shrinks liver tumors and/or their metastases. Determine the pharmacokinetics (PK) in patients with liver cancer. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Carcinoma, Hepatocellular |
- Drug: Nexavar (Sorafenib, BAY43-9006)
- Drug: Placebo
|
| |
| Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Häussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. |
| |
| Completed |
| 602 |
| November 2008 |
| November 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Ages eligible for study: 18 years and above, Genders eligible for study: both
- Patients who have a life expectancy of at least 12 weeks
- Patients with histologically or cytologically documented HCC
- Patients must have at least one tumor lesion that meets both of the following criteria: (1) Accurately measured in at least one dimension according to RECIST (2) Not previously treated with local therapy
- Patients who have an ECOG PS of 0, 1, or 2
Exclusion Criteria:
- Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to entry is permitted
- Renal failure requiring hemo- or peritoneal dialysis
- History of cardiac disease
- Active clinically serious infections
- Known history of human immunodeficiency virus (HIV) infection
- Known central nervous system tumors including metastatic brain disease
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, France, Germany, Greece, Israel, Italy, Mexico, New Zealand, Peru, Poland, Romania, Russian Federation, Spain, Switzerland, United Kingdom |
| |
| NCT00105443 |
| Therapeutic Area Head, Bayer HealthCare AG |
| 100554, EudraCT No: 2004-001773-26, SHARP |
| Bayer |
|
| Study Director: |
Bayer Study Director |
Bayer |
|
|
| Bayer |
| June 2009 |
