E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Clear cell renal cell carcinoma after surgery with no evidence of residual disease and with high risk of recurrence |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 4.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10038416 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy of treatment by assessing the disease-free survival and overall survival in the treatment arm compared to the placebo arm.
|
|
E.2.2 | Secondary objectives of the trial |
To evaluate the safety of the antibody therapy and the impact on the quality of life. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Prior nephrectomy of primary renal cell carcinoma with documented clear cell histology - Adenectomy of regional lymph nodes and staging is required - No evidence of macroscopic and microscopic residual disease - Patients diagnosed of having one of the following (referring to TNM classification, 6th edition UICC, 2002): * histologically proven stage T3bN0M0 or T3cN0M0 or T4N0M0 * any histologically proven T stage and N+ disease * primary tumor T1bN0M0 or T2N0M0 or T3aN0M0, each with microscopic vascular invasion and grade >/= III (grading system with at least 3 grades) - ECOG of 0 - Not more than 6 weeks after nephrectomy - Negative HIV- and hepatitis test - Negative pregnancy test for women of child-bearing potential - Women of child-bearing potential must be taking adequate contraceptive precautions - Willingness to return to the study site for long term control visits until recurrence - Age >/= 18 years - Ability to provide written informed consent |
|
E.4 | Principal exclusion criteria |
- Pre-exposure to murine/chimeric antibody therapy - Patients who require or are likely to require corticosteroids for another disease (patients on physiologic corticosteroid replacement therapy may be included in the study at the discretion of the investigator) - Prior organ transplantation - Laboratory values obtained </= 14 days prior to registration: * White blood cells (WBC) </= 3.0 x 10 (exp8)/dl * Platelet count </= 100 x 10 (exp8)/dl * Hemoglobin </= 6.2 mmol/l (equals 10 g/dl) * Total bilirubin >/= 1.5 ULN * ASAT, ALAT >/= 3 x ULN * Serum creatinine >/= 2x ULN - History of prior malignancies within the last 5 years, except for surgically-cured non-melanoma skin cancer, or cervical carcinoma in situ. - Prior radiation or chemotherapy within the last 5 years. - Patients who are pregnant, nursing or of reproductive potential and are not practising an effective method of contraception. - Any unrelated illness, e.g. active infection, inflammation, medical condition or laboratory abnormalities, which in the judgement of the investigator will significantly jeopardize patients' clinical status.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary study endpoints are disease-free survival and overall survival. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
End of long term follow up (LPLV) |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 60 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 60 |