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 | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10038413 |
E.1.2 | Term | Renal cell carcinoma stage III |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10038414 |
E.1.2 | Term | Renal cell carcinoma stage IV |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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E.2.2 | Secondary objectives of the trial |
• Progression free survival • Duration of response • Immunological response • Safety and tolerability
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Histologically or cytologically confirmed renal cell carcinoma (clear cell and papillary types). Biopsy of a metastasis is permitted if the primary tumor is inapproachable. 2. Metastatic or inoperable locally advanced renal cell cancer. 3. Patient must be eligible for therapy with IFN-α. 4. Measurable disease defined by the presence of at least one measurable lesion documented on CT scan (lesion diameter ≥ 2.0 cm measured by a standard (conventional) CT scanner or ≥ 1.0 cm measured by a spiral CT scanner). 5. Favorable or moderate risk group prognosis by MSKCC (Motzer) criteria (score 0-2). 6. Karnofsky performance status ≥ 70. 7. Age ≥ 18 years. 8. Life expectancy > 3 months. 9. Patient has the following blood counts at baseline: • absolute neutrophil count (ANC) ≥ 1.5 x 109/L • platelets ≥ 100 x 109/L • haemoglobin ≥ 100 g/L 10. Patient has the following blood chemistry levels at baseline: • creatinine ≤ 1.5 × upper limit of normal • bilirubin ≤ 2 × upper limit of normal • aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal. AST and ALT allowed ≤ 5 × upper limit of normal for patients with liver metastases. 11. If fertile, the patient agrees to use an effective method of contraception from the screening visit through the duration of study participation (barrier method for males; hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide or abstinence for females). 12. The patient is willing and able to comply with the treatment and scheduled follow-up visits and examinations. 13. Patient is capable of understanding the parameters outlined in the protocol and able to sign a written informed consent form. |
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E.4 | Principal exclusion criteria |
1. Pregnant or breast-feeding women are prohibited to take part in the study. 2. A serious uncontrolled medical disorder or active infection which are either ongoing or have resolved within 2 weeks before the first dose of the study treatment and which in the opinion of the investigator would impair the patient’s ability to receive the study treatment. 3. History of any malignancy within the past 5 years or any concurrent malignancy, with the exception of the following malignancies, which may still be included if successfully treated: non-melanoma skin cancer, cervical cancer in situ, ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) of breast. 4. History and/or signs of parenchymal brain metastases. 5. Significant cardiac disease including: history (within the past 6 months) or current unstable angina pectoris, congestive heart failure of stage III-IV (NYHA), or myocardial infarction within the past 12 months; or patients with uncontrolled arterial hypertension. 6. History of a stroke within the past 5 years and/or transient ischemic attack within the past 6 months. 7. Acute illness or evidence of infection, including unexplained fever (body temperature > 100.5 degrees F or 38.1degrees C) within 2 weeks prior to start of treatment. 8. Treatment with beta-blockers, excluding topical therapy for glaucoma, within 5 days prior to the start of the study treatment and during the 4 day ABR-217620 treatment period. 9. Treatment with systemic corticosteroids within 2 weeks prior to the start of treatment or the patient will likely require such treatment throughout the study. 10. Active autoimmune disease requiring therapy or any history of systemic lupus erythematosis or rheumatoid arthritis. 11. Treatment with biological response modifiers within 3 weeks of the first dose of the investigational products and up to the End-of-Study visit. 12. Known positive serology for HIV (patients with a known history of HIV will be excluded because of potential for unforeseen toxicity and morbidity in the immunocompromised host). 13. Chronic hepatitis with advanced, decompensated hepatic disease or cirrhosis of the liver or history of a chronic virus hepatitis or the known virus carrying. Patients who recovered from Hepatitis A are allowed to enter the study. 14. Treatment with anticoagulants within 2 weeks prior to the start of treatment, except when used to maintain the patency of a central or peripheral venous line. If a patient requires anticoagulants, his eligibility should be discussed with the Medical Monitor prior to enrollment. 15. Radiotherapy less than 4 weeks before the start of treatment. The patient should fully recover from the side effects of radiotherapy to start the study treatment. 16. Major surgery or tumor embolization less than 4 weeks before the start of treatment. The patient should fully recover after the surgery to start the study treatment. 17. Previous history of exposure to murine monoclonal antibodies or known hypersensitivity to murine proteins. 18. Patients currently on renal dialysis treatment. 19. Known allergy or hypersensitivity to aminoglycosides and kanamycin. 20. Previous systemic anti-tumor therapy for RCC (including immunotherapy with IFN-α or IL-2 or any chemotherapy) with the exception of sunitinib or other oral antiangiogenic therapy. Symptomatic treatment with hormonal therapy (e.g. megestrol, medroxyprogesteron or tamoxifen) is allowed as it is not to be regarded as systemic anti-tumor therapy for RCC. 21. Participation in any other study involving investigational drugs for treatment of RCC within the last 6 weeks. The patients must not participate in any other clinical trial while on this trial (with the exception of off-drug follow-up).
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
ABR-217620 plus background medication (interferon alpha) tested against interferon alpha only |
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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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
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 |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 6 |