E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Histologically documented, progressive, advanced or metastatic sarcoma after adjuvant and/or first line antracycline-based regimen |
sarcoma dei tessuti molli metastatico o ricaduto dopo trattamento chemioterapico con antracicline |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10041299 |
E.1.2 | Term | Soft tissue sarcomas |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
Overall response rate (proportion of patients with confirmed partial and complete responses).Overall response rate (proportion of patients with confirmed partial and complete responses). |
determinare il tasso di risposta globale (remissioni parziali + complete). |
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E.2.2 | Secondary objectives of the trial |
Time to progression (TTP) Overall disease control rate (Proportion of patients who have a best response rating of complete response [CR], PR or SD according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, that is maintained for at least 28 days from the first demonstration of that rating) Overall duration of response. Overall survival (OS) EMEND.2 Immunohistochemical analysis (IHC) of expression of PDGF-R alpha and beta on paraffin-embedded tissue |
determinare il tempo alla progressione,il tasso di controllo della malattia,la durata della risposta e la sopravvivenza globale (OS) EMEND.2 analisi immunoistochimica dell`espressione di PDGF-R alfa e beta nel tessuto |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
ALTRI SOTTOSTUDI: valutazione eventuale espressione del recettore del PDGF (plateled-derived growth factor receptor alfa e beta) sul tessuto tumorale.
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E.3 | Principal inclusion criteria |
Histologically documented, progressive, advanced or metastatic sarcoma after adjuvant and/or first line antracycline-based regimen; At least one unidimensional target lesion (RECIST criteria); Age ≥ 18 years; Eastern Cooperative Oncology Group (ECOG) performance status  2; Life expectancy ≥ 12 weeks; The following laboratory parameters: Absolute neutrophyl count (ANC) > 1,5 x 109/L Platelet Count > 100X 109/L Serum Creatinine < 1,5 x the upper limit of normal Serum bilirubin < 1,5 mg/dL Alkaline phosphatase, alanine transaminase (ALT) and aspartate transaminase(AST) < 2,5 x the upper limit of normal; in case of hepatic metastases < 5 x the upper limit of normal. |
diagnosi istologica di sarcoma dei tessuti molli metastatico o ricaduto dopo trattamento chemioterapico con antracicline; malattia misurabile per almeno 1 dimensione (criteri RECIST); eta' >18 anni; PS (ECOG)  2; aspettativa di vita  3 mesi; adeguata riserva midollare, funzionalita' epatica e renale; consenso informato scritto. |
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E.4 | Principal exclusion criteria |
Major surgery within 4 weeks of study entry; radiotherapy within 3 weeks of study entry; Previous or concurrent cancer that is distinct in primary site or histology from STS, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to entry is permitted; Renal failure requiring hemo- or peritoneal dialysis; History of cardiac disease: congestive heart failure > New York Heart Association (NYHA) class 2; active coronary artery disease (CAD); cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin), or uncontrolled hypertension. Myocardial infarction more than 6 months prior to study entry is permitted; Active clinically serious infections (> grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 3.0); Known history of human immunodeficiency virus (HIV) infection; Known Central Nervous System tumors including metastatic brain disease; Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry; History of organ allograft; Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results; Known or suspected allergy to the investigational agent or any agent given in association with this trial; Patients unable to swallow oral medications. Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug. Both men and women enrolled in this trial must use adequate barrier birth. |
aritmia cardiaca (richiedente l'uso di antiaritmici); insufficienza cardiaca congestizia (> New York Heart Association (NYHA) classe 2); ischemia cardiaca o coronaropatia attiva; chirurgia < 4 settimane dall'ingresso nello studio; radioterapia < 3 settimane dall'ingresso nello studio; allotrapianto in anamnesi; diagnosi di sanguinamento gastrico < 30 gg dall'ingresso nello studio; gravidanza o allattamento; malattie concomitanti serie o infezioni non controllate; segni clinici di metastasi cerebrali e/o meningee. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Overall response rate is defined as the proportion of patients with the best tumor response (confirmed partial or complete response) that is achieved during treatment or within 30 days after termination of active therapy that is confirmed according to the RECIST tumor response criteria. |
Tasso di risposta globale (ORR): proporzione di pazienti che hanno ottenuto la migliore risposta (risposta parziale o completa) durante il trattamento o entro 30 giorni dal termine del trattamento confermata secondo i criteri di risposta RECIST. |
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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 | No |
E.6.4 | Safety | No |
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 | 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 |
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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.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 4 |
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 | No |
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
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SE VERRa' OSSERVATO UN NUMERO DI RISPOSTE MINORE O UGUALE A 2 LO STUDIO VERRa' INTERROTTO PREMATURAMENTE |
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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 |