Status:
COMPLETED
Sorafenib Dose Escalation in Renal Cell Carcinoma
Lead Sponsor:
Bayer
Conditions:
Carcinoma, Renal Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of advanced kidney cancer. It is also currently being tested in various other cancers. Sorafenib works by stop...
Detailed Description
Issues on Outcome Measure "Safety and tolerability" will be addressed in the Adverse Events section.
Eligibility Criteria
Inclusion
- Age \> 18 years.
- Metastatic clear cell RCC (renal cell carcinoma)
- Subjects with at least one uni-dimensional measurable lesion.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Memorial Sloan Kettering Cancer Center (MSKCC) good or intermediate category
- Life expectancy of at least 12 weeks.
- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to treatment
- Signed informed consent must be obtained prior to any study specific procedures.
- Subjects must have received no prior systemic anticancer therapy for the treatment of their renal cell carcinoma
- Prior total nephrectomy
Exclusion
- History of cardiac disease
- History of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
- Active clinically serious infections (\> grade 2 National Cancer Institute-Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] version 3.0)
- Symptomatic metastatic brain or meningeal tumors unless the subject is \> 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry.
- Subjects with evidence or history of bleeding diathesis
- Deep vein thrombosis and/or pulmonary embolus within 12 months of the start of treatment.
- Delayed healing of wounds, ulcers or bone fractures
- Subjects with pre-existing thyroid abnormality whose thyroid function cannot be maintained within the normal range by medication
- Subjects undergoing renal dialysis
- Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and three months after the completion of trial.
- Prior adjuvant sorafenib is excluded.
- Radiotherapy during study or within 3 weeks of start of study drug
- Major surgery within 4 weeks of start of study
- Investigational drug therapy outside of this trial during or within 4 weeks of study entry
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00618982
Start Date
February 1 2008
End Date
January 1 2011
Last Update
December 24 2015
Active Locations (22)
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1
Bordeaux, France, 33000
2
La Roche-sur-Yon, France, 85925
3
Marseille, France, 13385
4
Nantes, France, 44805