Phase 2
Completed N=25
Evaluate Safety and Tolerability in Dose Escalation of Sorafenib in Advanced Renal Cell Cancer
Source: ClinicalTrials.gov NCT01189370 ↗Enrolled (actual)
25
Serious AEs
56.0%
Results posted
Jun 2017
Primary outcomePrimary: Number of Participants Who Could Tolerate Each Dose Level — 25; 16; 12; 16 Participants
Summary
The purpose of this study is to determine whether an increase in the dose of sorafenib when given over five instead of 7 days/week, will result in an improvement of the response rate (degree of shrinkage of your cancer) and an improvement in the length of time that sorafenib will control your cancer, without causing a significant increase in side effects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Could Tolerate Each Dose Level |
25; 16; 12; 16; 12; 6 | — |
| SECONDARY Overall Number of Participants That Had Disease Progression on Study |
17 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years old.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
- Adequate bone marrow, liver and renal function as assessed by the following:
- Hemoglobin ≥ 9.0 grams per deciliter (g/dl)
- Absolute neutrophil count (ANC)≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- and aspartate aminotransferase (AST) ≤ 2.5 times the ULN (≤ 5 x ULN for patients with liver involvement)
- Creatinine class II New York Heart Association (NYHA). Must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within past 6 months.
- Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
- Patients who have received prior sorafenib are ineligible.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
- Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B/C.
- Active clinically serious infection > CTCAE Grade 2.
- Thrombosis or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months. Patients with renal or caval thrombosis related to the primary renal tumor would not be excluded and are eligible.
- 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.
- Serious non-healing wound, ulcer, or bone fracture.
- Evidence or history of bleeding diathesis or coagulopathy.
- Major surgery, open biopsy or significant traumatic injury within 4 weeks of 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 (NCT01189370). 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.