E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced pancreatic cancer patients |
Pazienti con cancro del pancreas in stadio avanzato |
|
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 | PT |
E.1.2 | Classification code | 10059326 |
E.1.2 | Term | Pancreatic carcinoma stage IV |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
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 |
Valutazione dell'attivita' della combinazione di Pemetrexed e Oxaliplatino nel trattamento di seconda linea in pazienti con adenocarcinoma pancreatico in progressione dopo trattamento chemioterapico con schema contenente Gemcitabina. |
|
E.2.2 | Secondary objectives of the trial |
Time to treatment failure; Tolerability; TTP; Clinical Benefit; Overall Survival. |
Durata della risposta; Tossicita'; Tempo a progressione; Clinical Benefit; Sopravvivenza globale. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. written informed consent; 2. Histological diagnosis of pancreatic cancer; 3. Advanced disease; 4. At least one measurable lesion (RECIST criteria); 5. Age 18-70 6. ECOG 0-1; 7. Adequate bone marrow, epatic and renal function; 8. Progressive disease to previous chemotherapy with Gemcitabine. |
1. Consenso informato scritto; 2. Diagnosi istologica o citologica di adenocarcinoma pancreatico; 3. Malattia metastatica; 4. Presenza di almeno una lesione misurabile secondo i criteri RECIST; 5. Eta' 18-70 anni; 6. ECOG 0-1; 7) Adeguata funzionalita' midollare (Hb > 9 g/L, PMN > 1.50 x 10^3/uL, piastrine > 100 x 10^3/uL), epatica e renale (AST/ALT < 5 x ULN, clearance della creatinina > 50%); 8) Progressione clinica, radiologica o biochimica a precedente trattamento con schema chemioterapico contenente gemcitabina |
|
E.4 | Principal exclusion criteria |
1. Previous chemotherapy containing Pemetrexed or Oxaliplatin; 2. Previous or concomitant cancers, except curatively treated cervical carcinoma in situ or non-melanoma skin cancer; 3. Pregnant or lactating women; 4. Peripheral Neuropathy grade >2; 5. concomitant treatment with other sperimental drugs; 6. Medical controindications to chemotherapic treatment. |
1. Precedente trattamento chemioterapico con Pemetrexed od Oxaliplatino; 2. Precedenti o concomitanti neoplasie, escluso il carcinoma in situ della cervice uterina ed i carcinomi epidermoidali della cute trattati adeguatamente o altre neoplasie se il paziente e' stato libero da malattia per almeno 5 anni 3. Gravidanza o allattamento in atto; 4. Neuropatia periferica di grado >2; 5. Trattamento concomitante con altri farmaci sperimentali; 6. Presenza di controindicazioni mediche al trattamento chemioterapico. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Response Rate |
Tasso di risposta |
|
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 | 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 | 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 | 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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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
| |
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 |