E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non-Small Cell Lung Cancer related Cachexia (NSCLC-C) |
Carcinoma polmonare non a piccole cellule - Cachessia (NSCLC-C) |
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E.1.1.1 | Medical condition in easily understood language |
Weight-loss and muscle mass loss due to NSCLC-C |
Perdita di peso e perdita di massa muscolare dovuta a NSCLC-C |
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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 | SOC |
E.1.2 | Classification code | 10027433 |
E.1.2 | Term | Metabolism and nutrition disorders |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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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 |
To evaluate the safety and tolerability of Anamorelin HCl |
Valutare la sicurezza e la tollerabilità di Anamorelin HCl |
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E.2.2 | Secondary objectives of the trial |
1. To evaluate the effect of Anamorelin HCl on body weight 2. To evaluate the effect of Anamorelin HCl on muscle strength as measured by hand grip strength 3. To evaluate the effect of Anamorelin HCl on quality of life as assessed using the FAACT (Functional Assessment of Anorexia/Cachexia Treatment) and the FACIT F (Functional Assessment of Chronic Illness Therapy – Fatigue) (see Appendix II) |
1. Valutare l’effetto di Anamorelin HCl sul peso corporeo 2. Valutare l’effetto di Anamorelin HCl sulla forza muscolare misurata tramite misurazione della forza di presa della mano (FPM) 3. Valutare l’effetto di Anamorelin HCl sulla qualità della vita misurata usando la scala FACIT-F (Functional Assessment of Chronic Illness Therapy – Fatigue) e FAACT (Functional Assessment of Anorexia/Cachexia Treatment) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The patient has completed the Day 85 Visit in the original trial (Study HT ANAM-301 or HT-ANAM-302) and the Investigator considers the patient to be appropriate to continue to receive an additional 12 weeks of study drug administration. The patient must start dosing on the extension study within 5 days of completing dosing on the original trial. • Females and males at least 18 years of age • ECOG performance status less than / equal to 2 |
• Il paziente ha completato la visita dell’85° giorno nella sperimentazione originaria (Studio HT-ANAM-301 o HT-ANAM-302) e il medico sperimentatore considera il paziente idoneo a continuare a ricevere un’ulteriore somministrazione del farmaco in studio per 12 settimane. Il paziente deve iniziare la somministrazione per l'estensione di studio entro 5 settimane dal completamento della somministrazione della sperimentazione originaria. • Uomini e donne di almeno 18 anni di età • Stato di validità ECOG minore/ uguale a 2 |
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E.4 | Principal exclusion criteria |
Women who are pregnant or breast-feeding • Patients who have received 2 prior regimens of cytotoxic chemotherapy and are undergoing, or planning to undergo, a third regimen of cytotoxic chemotherapy • Patients must not be planning to initiate a new chemotherapy and/or radiation therapy regimen in the middle of the 12-week treatment period at the time of enrollment into this extension study. • Had major surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to enrollment into the extension study. Patients must be well recovered from acute effects of surgery prior to screening. Patients should not have plans to undergo major surgical procedures during the treatment period. • Patients unable to readily swallow oral tablets. Patients with severe gastointestinal disease (including esophagitis, gastritis, malaborption, or obstructive symptoms) or intractable or frequent vomiting are excluded. • Has known or symptomatic brain metastases |
Donne in stato di gravidanza o in allattamento. I pazienti che hanno completato precedentemente 2 o più cicli di chemioterapia citotossici e stanno iniziando, o pianificando di iniziare, un terzo ciclo di chemioterapia citotossica. • I pazienti non devono pianificare di iniziare un nuovo ciclo di chemioterapia e/o radioterapia durante il periodo di trattamento di 12 settimane quando vengono iscritti a questa estensione di studio. • Pazienti sottoposti ad operazioni di alta chirurgia (inserimento di catetere venoso centrale e biopsie tumorali non sono considerate operazioni di alta chirurgia) entro 4 settimane prima dell’iscrizione all’estensione di studio. I pazienti devono essersi ripresi dagli effetti acuti di operazioni chirurgiche prima di effettuare lo screening. I pazienti non possono essere sottoposti ad operazioni di alta chirurgia durante il periodo di trattamento. • Pazienti che non sono in grado di inghiottire compresse. Pazienti affetti da malattie gastrointestinali acute (ivi incluse patologie quali esofagite, gastrite, sindrome da malassorbimento, o sintomi ostruttivi) o con singhiozzi persistenti o vomito frequenti sono esclusi dallo studio. • Pazienti con metastasi celebrali sintomatiche o note |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Changes in body weight from baseline of the HT-ANAM-301 or HTANAM- 302 trials 2. Change in Hand Grip Strength of the non-dominant hand 3. Change in HGS of the dominant hand 4. Quality of life |
Variazioni del peso corporeo rispetto al baseline degli studi HT-ANAM-301 o HTANAM-302. 2. Variazioni della forza di presa della mano non dominante. 3. Variazioni della HGS della mano dominante 4. Qualità della vita |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Changes in body weight at Weeks 4, 8, 12 2. Changes in Hand Grip Strength of non-dominant hand at Weeks 8, 12 3. Changes in Hand Grip Strength of dominant hand at Weeks 8, 12 4. Quality of life as assessed by FAACT and FACIT-F at Weeks 4, 8, 12 |
1. Variazioni del peso corporeo alle settimane 4, 8, 12 2. Variazioni della forza di presa della mano non dominante alle settimane 8, 12 3. Variazioni della forza di presa della mano dominante alle settimane 8, 12 4. Qualità della vita accertata da FAACT e FACIT-F alle settimane 4, 8, 12 |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 48 |
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 | No |
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 |
Australia |
Canada |
Israel |
Russian Federation |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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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A follow-up visit will be completed 28 days (±7 days) after the last dose of study drug for adverse event assessment. The patient will continue in the survival follow-up for the original trial in which they participated (HT-ANAM-301 or HT-ANAM-302). |
Una follow-up visit verrà completata 28 giorni (±7 giorni) dopo l'ultima dose di farmaco sperimentale per l'accertamento degli eventi avversi. Il paziente continuerà il follow-up della sopravvivenza secondo lo studio originale cui ha partecipato. |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 29 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 24 |
E.8.9.2 | In all countries concerned by the trial days | 0 |