Status:
COMPLETED
Study of Sorafenib in Patients With Advanced Renal Cell Carcinoma
Lead Sponsor:
Egyptian Foundation For Cancer Research
Conditions:
Metastatic Renal Cell Carcinoma
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
The purpose study is to evaluate the efficacy and safety of Sorafenib as first line treatment for patients - unsuitable for another approved first line therapy - with advanced RCC in the Middle East R...
Eligibility Criteria
Inclusion
- The patient must provide written informed consent prior to receiving Sorafenib.
- The male or female patient must be at least 18 years of age.
- The patient must have pathologically proven advanced Renal Cell Carcinoma.
- Only patients with measurable disease (According to RECIST) at baseline should be included in protocol where Disease Control Rate (DCR) is the primary endpoint.
- The patient requires Sorafenib as First line therapy as the patient is unsuitable for another approved first line therapy for advanced RCC.
- The patient must be, in the Investigator's opinion, reasonably likely to benefit from treatment with Sorafenib as a single agent.
- The patient must have an Eastern Cooperative Oncology Group performance status of 0 - 2.
- The patient will not require other systemic anti-cancer chemotherapy, immunotherapy or hormonal therapy, except for bisphosphonates while taking Sorafenib.
- Both male and female patients must use adequate barrier birth control methods during their participation in the protocol. The birth control methods must be used for 4 weeks for female patients and for 3 months for male patients after discontinuation of treatment with Sorafenib.
- For patients, who have had major surgery, the wound must be completely healed prior to receiving Sorafenib treatment (4 weeks).
- The patient must have within normal Renal \& Hepatic function.
- The patient must have within normal CBC.
Exclusion
- Patients who are currently enrolled in or have previously participated in any other Sorafenib trial.
- Suitable or received any other systemic therapy for treatment RCC (IL-2, INF)
- Patients who have a life expectancy of less than 2 months.
- Patients with metastatic brain or meningeal tumours.
- Patients are excluded who require any of the following:
- Investigational drug therapy during the treatment with Sorafenib or within 30 days prior to their first dose of Sorafenib.
- Concomitant Rifampicin.
- Non-measurable disease according to RECIST.
- Concomitant St. John's Wort (Hypericum perforatum).
- Warfarin (or similar medication) is allowed.
- Women who are pregnant or breast-feeding. Women of childbearing potential must have a negative pregnancy test performed within seven days of the start of study drug (please note that no laboratory data are collected in this study).
- Patients with congestive heart failure greater than NYHA functional class II (symptomatic during ordinary activity)
- Patients with cardiac arrhythmias greater than Grade 1 NCI CTCAE, Version 3.0 (conduction abnormality and supraventricular arrhythmia present but patient is asymptomatic; intervention not indicated, palpitations present and QTc \> 0.45 - 0.47 second).
- Patients with active coronary artery disease or ischemia.
- Patients with Child-Pugh class C hepatic impairment.
- Patients with severe renal impairment (calculated creatinine clearance of \< 30 ml/min) or who require dialysis.
- Patients with active uncontrolled hypertension.
- Patients with recent or active bleeding diathesis.
- Patients with any medical condition which could jeopardize their safety while taking an investigational drug.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00848640
Start Date
October 1 2008
End Date
March 1 2010
Last Update
May 26 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Egyptian Foundation For Cancer Research
Cairo, Egypt, 11553