NL-OMON50236CompletedPhase 3
A Phase III Randomised Double-blind Study Comparing Sorafenib With Placebo In Patients With Resected Primary Renal Cell Carcinoma at High or Intermediate Risk of Relapse - SORCE
rologie0 sites50 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 50
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •-Histologically proven RCC(All cell types of RCC are eligible, except pure
- •oncocytoma as distinct from an RCC with oncocytic features).
- •-No evidence of residual macroscopic disease on post-operative CT scan after
- •resection of RCC. Patients with clear cell or non-clear cell tumours are
- •-Patients with a pulmonary nodule may be eligible but the nodule needs to be
- •<5mm diameter and have been stable for at least 3 months (confirmed by CT
- •-Patients with *Intermediate* or *High* risk per the Leibovich score 3 to 11
- •(Special pathology guidelines for Leibovich scoring of tumour samples see
- •appendix 1)
- •-Subjects must be >18 years in age
- •-Women of childbearing age must have a negative pregnancy test and must use
- •adequate contraception during the treatment phase of the study and for 9
- •months afterwards. Women who wish to breast feed are not eligible for the
- •-Adequate bone marrow function (WBC > 3.4x109/l, platelets > 99x109/l), renal
- •function (creatinine < 2.5 x upper limit of normal and hepatic function (LFT <
- •1.5 x upper limit of normal) within 14 days prior to randomisation
- •- Patients should have had surgery at least 4 weeks but no more than 3 months
- •(91 days) prior to treatment start date
- •- Serum Amylase < 1.5 x upper limit of normal
- •-Prothrombin (PT) or INR (International Normalized Ratio) and Prothrombin Time
- •(PTT) < 1.5 x upper limit of normal
- •-WHO Performance Status 0 or 1 (Appendix 2)
- •-Written Informed Consent obtained
Exclusion Criteria
- •-Prior anti-cancer treatment for RCC other than nephrectomy
- •-Cardiac arrhythmias requiring anti-arrhythmics (beta-blockers and digoxin are
- •allowed), symptomatic coronary artery disease or ischaemia, myocardial
- •infarction within the last 6 months, congestive cardiac failure > NYHA Class II
- •-Active clinically serious bacterial or fungal infections
- •-Known history of human immunodeficiency virus (HIV) infection or chronic
- •hepatitis B or C
- •-Pregnant or breast-feeding patients. Women of childbearing potential must have
- •a negative pregnancy test performed within seven days prior to the start of
- •drug. Both men and women enrolled in this trial must use adequate birth control
- •-Prior malignancy (except for cervical carcinoma in situ or adequately treated
- •basal cell carcinoma)
- •-Concomitant medications which have adverse interactions with sorafenib:
- •rifampin, grapefruit juice, ritonavir, ketoconazole, itraconazole and St John*s
- •-Patients with uncontrolled hypertension
- •-Patients with a pulmonary nodule *5 mm diameter or multiple
- •pulmonary nodules.
Investigators
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