E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with multiple brain metastases from solid tumors. |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10027476 |
E.1.2 | Term | Metastases |
|
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 |
- Selective uptake of 131I-L19SIP or 124I-L19SIP in brain lesions. - Safety of combined administration of 131I-L19SIP and WBRT. |
|
E.2.2 | Secondary objectives of the trial |
- Intracranial, extra cranial and overall response - Overall survival - Clinical performance index |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Unresectable multiple brain metastasis from histologically or cytologically confirmed solid tumors Males or females, age > 18 years Measurable disease defined as at least one metastatic brain lesion that can be accurately and serially measured by the modified RECIST criteria (version 1.1) Prior therapy for metastatic disease allowed ECOG performance status < 3 Life expectancy of at least 12 weeks Absolute neutrophil count > 1.5 x 109/L, hemoglobin > 9.0 g/dL and platelets > 100 x 109/L Total bilirubin &#8804; 30 �mol/L (or &#8804; 2.0 mg/Dl) ALT and AST &#8804; 2.5 x the upper limit of normal (5.0 x ULN for patients with hepatic involvement with tumor Serum creatinine < 1.5 x ULN All toxic effects of prior therapy must have resolved to &#8804; Grade 1 unless otherwise specified above Negative serum pregnancy test (for women of child-bearing potential only) at screening |
|
E.4 | Principal exclusion criteria |
Primary ocular melanoma Patients with brain metastasis amenable for surgical excision or stereotactic irradiation (radiosurgery) 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 & Ti) or any cancer curatively treated < 5 years prior to study entry Patients with history of whole brain irradiation History of HIV infection or infectious hepatitis B or C Presence of active infections (e.g. requiring antibimicrobial therapy) or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study. Inadequately controlled cardiac arrhythmias including atrial fibrillation Heart insufficiency (> Grade II, New York Heart Association (NYHA) criteria) Uncontrolled hypertension Ischemic peripheral vascular disease (Grade IIb-IV) Severe diabetic retinopathy Active autoimmune disease History of organ allograft or stem cell transplantation Recovery from major trauma including surgery within 4 weeks prior to administration of study treatment Breast feeding female Previous in vivo exposure to monoclonal antibodies for biological therapy in the 6 weeks before administration of study treatment Growth factors or immunomodulatory agents within 7 days of the administration of study treatment Patients in need of systemic treatment for rapidly progressive systemic disease during study treatment and up to 6 weeks after injection of therapeutic 131I-L19SIP |
|
E.5 End points |
E.5.1 | Primary end point(s) | |
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 | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Si propone anche di stabilire la risposta globale del trattamento e il prolungamento della sopravviv |
|
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 | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Studio prospettico non randomizzato |
|
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |