Phase 4
Completed N=120
Sorafenib Dose Ramp-Up in Hepatocellular Carcinoma (HCC)
Source: ClinicalTrials.gov NCT01203787 ↗Enrolled (actual)
120
Serious AEs
24.2%
Results posted
Feb 2015
Primary outcomePrimary: Total (Cumulative) Dose Delivery of Sorafenib — 49800; 38000 mg — p=0.0262
Summary
Open-label study to evaluate the safety and tolerability of Sorafenib dose ramp-up (starting at a lower dose and then gradually increasing the dose) versus standard Sorafenib dosing in subjects with unresectable and/or metastatic hepatocellular carcinoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total (Cumulative) Dose Delivery of Sorafenib |
49800; 38000 | 0.0262 sig |
| PRIMARY Cumulative Dose of Sorafenib |
53692; 41523 | — |
| SECONDARY Safety and Efficacy of Sorafenib Dosing Regimens |
92; 101 | — |
| SECONDARY Safety of Dosing Regimens as Assessed by the Frequency and Severity of Adverse Events According to National Cancer Institute- CTCAE |
19; 15 | — |
| SECONDARY Frequency and Severity of Adverse Events According to National Cancer Institute- CTCAE |
9; 8 | — |
| SECONDARY Number of Subjects With Dose Interruptions |
29; 20 | — |
| SECONDARY Number of Subjects With Dose Reductions |
40; 34 | — |
Eligibility Criteria
Inclusion Criteria
- HCC must be unresectable and/or metastatic
- CPT score 8.5 g/dl
- Absolute neutrophil count (ANC) > 1,500/mm3
- Platelet count > 50,000/mm3
- Total bilirubin 9
- ECOG PS >2
- Active alcohol dependence per PI discretion
- History of organ or bone marrow transplant
- Plans to relocate from the study center within the period of the trial
- Pregnancy or breastfeeding
- Contraindications to sorafenib
- Cardiac disease: Congestive heart failure > class II NYHA. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
- Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
- Known human immunodeficiency virus (HIV) infection
- Active clinically serious infection > CTCAE Grade 2.
- Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
- Bleeding
- Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug.
- Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug.
- Evidence or history of bleeding diathesis or coagulopathy
- Serious non-healing wound, ulcer, or bone fracture.
- Major surgery, open biopsy or significant traumatic injury within 4 weeks prior to first study drug.
- Use of St. John's Wort or rifampin (rifampicin).
- Known or suspected allergy to sorafenib or any agent given in the course of this trial.
- Any condition that impairs patient's ability to swallow whole pills.
- Any malabsorption problem.
Data sourced from ClinicalTrials.gov (NCT01203787). 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.