E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10038390 |
E.1.2 | Term | Renal cancer recurrent |
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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 |
Evaluation of efficacy (6 month PFS) |
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E.2.2 | Secondary objectives of the trial |
Progression Free Survival (PFS) Overall Survival (OS) Response Rate (RR) Tumor shrinkage Evaluation of safety Adverse events with any causal relationship with the study IMPs Serious adverse events with any causal relationship with the study IMPs Quality of Life (QoL) evaluation using the QLQ C-30 questionnaire Exploration of antiangiogenic parameters for response
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Adult patients (18th year of age completed). Signed and dated written informed consent form prior to any procedures related to this protocol. Histologically confirmed advanced clear cell renal cancer. Measurable disease. Failure of first line treatment of the combination bevacizumab and interferon A2 alpha. Performace status 0-2, according to ECOG. Satisfactory hematological parameters: WBC >4000mm3 PLT >100000/mm3 ANC>1200/mm3 Hemoglobin>9,0 g/dL (can be achieved with red blood cell transfusion) Satisfactory biochemical parameters: Serum creatinine<2xULN AST<2,5xULN ALT<2,5xULN Bilirubin<2xULN (For female patients) Absence of pregnancy (negative pregnancy test for women of reproductive age before enrollment). (For female patients) Non-lactating women. Use of efficient contraceptive measures (women and men) to prevent possible pregnancy of female patient or female partner of a male patient during treatment and until 6 months after the end of treatment
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E.4 | Principal exclusion criteria |
Prior treatment with mTOR inhibitor and/or TKI. Major surgery (including open biopsy) or insufficient recovery or existence of major trauma within 4 weeks before enrollment. Uncontrolled hypertension. Active infection requiring systemic treatment within 4 weeks prior to enrollment. Minor surgery (e.g. catheter replacement) within 2 days before enrollment. Scheduled major surgery within the treatment period. Medical history in the last 6 months prior to enrollment of significant cardiovascular disease, diabetes, cardiac infarction, unstable angina, uncontrolled arrhythmia or significant heart failure. Indications of uncontrolled metastases or disease progression in CNS lesions (the suspicion of uncontrolled metastases or disease progression should be eliminated by imaging techniques within 14 days prior to enrollment). Medical history in the last 5 years prior to enrollment of any other malignancies (excluding the basal or squamous skin cell carcinoma or in situ carcinoma of the cervix). History of non-healing wound including active gastric ulcer. History of fistula in the last 6 months prior to enrollment. History of gastrointestinal perforation. Patient incapacity (for psychiatric or social reasons) to conform to the protocol. History of hemorrhagic predisposition. History of hypersensitivity to the medications under investigation. Significant proteinuria. Prior immunotherapy within 4 weeks prior to enrollment. Prior radiation treatment within 2 weeks prior to enrollment. Concomitant medication with inducers or strong inhibitors of the coenzyme CYP3A4. Concurrent participation in other interventional clinical trials with IMPs. History of chronic interstitial lung disease. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Evaluation of efficacy (6 month PFS) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |