Phase 3
Completed N=226
A Randomized, Double-Blinded, Placebo-Controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
Carcinoma, Hepatocellular
Source: ClinicalTrials.gov NCT00492752 ↗
Enrolled (actual)
226
Serious AEs
49.1%
Results posted
Jan 2011
Primary outcomePrimary: Overall Survival — 198; 127 days — p=0.014144
Summary
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 or shrinks liver tumors and / or their metastases
* Determine the pharmacokinetics (PK) in patients with liver cancer
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
198; 127 | 0.014144 sig |
| SECONDARY Time to Symptomatic Progression (TTSP) |
105; 103 | 0.497537 |
| SECONDARY Time to Progression (TTP) |
84; 41.5 | 0.000537 sig |
| SECONDARY Disease Control |
53; 12; 97; 64 | — |
| SECONDARY Change in Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8) Score From Baseline to Cycle 1 and Cycle 3 |
26; 26; 24; 25 | — |
| SECONDARY Change in Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) Score From Baseline to Cycle 3 and End of Treatment |
-10; -3; -25; -23 | — |
| SECONDARY Number of Participants With Different Tumor Response |
0; 0; 5; 1; 81; 21 | 0.67 |
| SECONDARY Duration of Response |
210; 252 | — |
| SECONDARY Time to Response |
84; 42 | — |
| SECONDARY Area Under the Curve From Time 0 to 12 Hours Post-dose (AUC 0-12) After 21 Days of Sorafenib Treatment |
35.7 | — |
| SECONDARY Normalized Area Under the Curve (AUC Norm) After 21 Days of Sorafenib Treatment |
6.6 | — |
| SECONDARY Maximum Concentration (Cmax) After 21 Days of Sorafenib Treatment |
4.44 | — |
| SECONDARY Normalized Maximum Concentration (Cmaxnorm) After 21 Days of Sorafenib Treatment |
0.66 | — |
| SECONDARY Time of Maximum Concentration (Tmax) After 21 Days of Sorafenib Treatment |
4.0 | — |
Eligibility Criteria
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 advanced Hepatocellular carcinoma (HCC) (unresectable, and/or metastatic) which has been histologically or cytologically documented
- Patients must have at least one tumor lesion that meets both of the following criteria
- Accurately measured in at least one dimension according to Response Evaluation Criteria in Solid Tumors (RECIST)
- Not been previously treated with local therapy
- Patients who have received local therapy, such as surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation are eligible. Previously treated lesions will not be selected as target lesions. Local therapy must be completed at least 4 weeks prior to the baseline scan
- Patients who have an Eastern Co-operative Oncology Group (ECOG) Performance Status 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 [Noninvasive papillary carcinoma], Tis [Carcinoma in situ: "flat tumor"]&T1 [Tumor invades subepithelial connective tissue]). Any cancer curatively treated > 3 years prior to entry is permitted
- History of cardiac disease
- Active clinically serious infections
- Known history of human immunodeficiency virus (HIV) infection
- Known central nervous system (CNS) tumors including metastatic brain disease
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
Data sourced from ClinicalTrials.gov (NCT00492752). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.