A randomised, open-label, multi-center phase II study of first-line treatment with BAY 43-9006 (Sorafenib) versus standard treatment with Interferon alpha-2a in patients with unresectable and/or metastatic renal cell carcinoma
- Conditions
- unresectable and/or metastatic renal cell carcinoma
- Registration Number
- EUCTR2005-000544-86-GB
- Lead Sponsor
- Bayer HealthCare AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
Male or female patients > 18 years of age
Patients who have a life expectancy of at least 12 weeks
Patients, who suffer from unresectable and/or metastatic, measurable predominantly clear cell RCC histologically or cytologically documented.
Patients must have undergone prior (at the time of primary diagnosis) complete surgical excision of primary RCC tumor.
Patients must have had no prior systemic therapy for advanced RCC. Prior systemic therapy is defined as any treatment with a chemotherapy agent (or regimen), an immunotherapy agent (or regimen) or an investigational treatment agent (or regimen) against the renal cell carcinoma. Megestrol acetate or medroxyprogesterone will constitute as a prior systemic therapy.
Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST) (Appendix 11.4).
Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1 (Appendix 11.1).
Adequate bone marrow, liver , and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening,
Hemoglobin >9.0 g/l
Absolute neutrophil count ( ANC)>1,500/mm3
Platelets> or = 100,000/µl
Total bilirubin < 1.5 x the upper limit of normal.
ALT and AST < 2.5 x upper limit of normal (< 5 x upper limit of normal for patients with liver involvement of their cancer).
Amylase and lipase < 1.5 x the upper limit of normal.
Serum creatinine < 2.0 x the upper limit of normal.
PT or INR and PTT < 1.5 x upper limit of normal (patients who receive anti-coagulation treatment with an agent such as warfarin or heparin will be allowed to participate. For patients on warfarin, close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement at pre dose, as defined by the local standard of care).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors ( Ta, Tis &T1) or any cancer curatively treated > 5 years prior to study entry.
Complete renal shut-down requiring hemo- or peritoneal dialysis
History of cardiac disease : congestive heart failure>NYHA class 2 ( Appendix 11.5): active cardiovascular disease( MI more than 6 months prior to study entry is allowed); cardiac arrhythmia requiring anti-arrythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension
Active clinically serious bacterial or fungal infections (> grade 2 NCI-CTCAE, Version 3)
Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to this brain tumour site at the time of study entry. Also the patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies (head CT or MRI at screening always required)
Patients with seizure disorder requiring medication (such as steroid anti-epileptics)
History of organ allograft
Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results
Known or suspected allergy to the investigational agent or any agent given in association with this trial
Any condition that is unstable or which could jeopardise the safety of the patient and his/her compliance in the study
Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of 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.
Concurrent anti-cancer chemotherapy, immunotherapy (including monoclonal antibodies) or hormonal therapy, except for bisphosphonates, during or within 30 days prior to start of study drug
Concomitant treatment with Megestrol acetate or Medroxyprogesterone
Investigational drug therapy during or within 30 days prior to randomisation
Prior use of inhibitors of the Ras / Raf-, MEK-, AKT kinase- and mTOR-signaling pathway or of Farnesyl transferase inhibitors
Prior use of investigational or licensed angiogenesis inhibitors (targeting VEGF/VEGFR, PDGF/PDGFR and other key molecules in angiogenesis) for example Bevacizumab
Biological response modifiers, such as G-CSF or GM-CSF, within 3 weeks prior to study entry or during study. (G-CSF and other hematopoietic growth factors may only be used in the management of acute toxicity such as febrile neutropenia when medically indicated or at the discretion of the investigator, however they may not be substituted for a required dose reduction.) [Patients taking chronic erythropoietin are permitted provided no dose adjustment is u
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method