Renal cell carcinoma of the clear cell type after nephrectomy and no evidence of residual disease MedDRA version: 14.1 Level: LLT Classification code 10038415 Term: Renal cell carcinoma stage unspecified System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Chimeric IgG monoclonal antibody cG250
Product Code: WX-G250 or cG250
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Girentuximab (INN)
CAS Number: 91613
Sponsors
Wilex AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Prior (partial or total) nephrectomy of primary renal cell carcinoma with documented clear cell histology 2. No evidence of macroscopic and microscopic residual disease (enlarged lymph nodes schould be removed) 3. Patients diagnosed of having one of the following (referring to TNM classification, 6th edition UICC, 2002): - Risk group I: T3aN0/XM0 or T3bN0/XM0 or T3cN0/XM0 or T4N0/XM0 - Risk group II: any T stage and N+ disease and M0 - Risk group III: T1bN0/XM0 or T2N0/XM0, each with grading >=3 (Fuhrman or any other nuclear grading system with at least 3 grades) 4. ECOG of 0-1 (see Appendix II) 5. Not more than 12 weeks between date of nephrectomy and randomization 6. Negative HIV I and II test 7. Negative Hepatitis B surface antigen (HbsAg) or Hepatitis C antibody result 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 631 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 233
Exclusion criteria
Exclusion criteria: 1. Pre-exposure to murine/chimeric antibody therapy 2. Patients who require or are likely to require systemic corticosteroids above Cushing doses for another disease (patients on physiologic corticosteroid replacement therapy may be included in the study at the discretion of the investigator) 3. Prior organ transplantation 4. Laboratory values obtained = 1.5 x upper limit of normal (ULN) - ASAT, ALAT >= 3 x ULN - Serum creatinine >= 2 x ULN 5. History of prior malignancies within the last 5 years, except for surgically-cured non-melanoma skin cancer, or cervical carcinoma in situ 6. Prior radiation or immunotherapy or chemotherapy within the last 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate disease-free survival and overall survival on cG250 therapy as compared to placebo;Secondary Objective: To evaluate quality of life and safety. To perform a population pharmacokinetic analysis.;Primary end point(s): The primary objectives are: - to evaluate the disease-free survival on cG250 therapy as compared to placebo - to evaluate overall survival on cG250 therapy as compared to placebo. ;Timepoint(s) of evaluation of this end point: disease-free survival: at a specified number of events (please refer to protocol) overall survival: After 419 OS events or 60 months after the last patient has been enrolled, whichever is the later | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - assess quality of life in the treatment and placebo arms (EORTC) - evaluate safety - perform a population pharmacokinetic analysis that provides an understanding of cG250 pharmacokinetics in patients receiving cG250 as adjuvant therapy;Timepoint(s) of evaluation of this end point: Quality of life: baseline, weeks 12 and 24, after 12 months Adverse events: baseline, during treatment, until 30 days after treatment Laboratory values: baseline, weeks 4, 8, 12, 16, 20, 24 during treatement, after 9 months (hematology and chemistry panel) Population pharmacokinetic analysis: baseline, weeks 4, 8, 12, 16, 20, 24 during treatement, after 9 months | — |
Countries
Argentina, Brazil, Canada, Czech Republic, Finland, France, Germany, Norway, Poland, Russian Federation, Spain, Sweden, Ukraine, United Kingdom, United States
Contacts
Public ContactRegulatory Affairs
Wilex AG
Outcome results
None listed