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) |
Caquexia asociada al carcinoma broncopulmonar no microcítico (NSCLCC) |
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E.1.1.1 | Medical condition in easily understood language |
Weight-loss and muscle mass loss due to NSCLC-C |
Pérdida de peso y de masa corporal magra debido a un carcinoma broncopulmonar no microcítico |
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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 | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002646 |
E.1.2 | Term | Anorexia |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064015 |
E.1.2 | Term | Cancer cachexia |
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 |
Evaluar la seguridad y la tolerabilidad de HCl de Anamorelina |
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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. Evaluar el efecto de HCl de Anamorelina en el peso corporal. 2. Evaluar el efecto de HCl de Anamorelina en la fuerza muscular, medida mediante la fuerza de prensión manual. 3. Evaluar el efecto de HCl de Anamorelina en la calidad de vida, medida utilizando el FACIT-F (Evaluación funcional de la fatiga en el tratamiento de la enfermedad crónica) y FAACT (Evaluación funcional del tratamiento de la anorexia/caquexia). |
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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. |
- El paciente ha completado la Visita del Día 85 del ensayo clínico inicial (Estudio HT-ANAM-301 o HT-ANAM-302) y el Investigador considera que es apropiado para el paciente seguir recibiendo el fármaco del estudio durante 12 semanas más. El paciente deberá iniciar la administración de la dosis en el estudio de extensión en los 5 días posteriores tras finalizar la administración del fármaco en el ensayo clínico inicial. - Mujeres y varones de al menos 18 años de edad. - Estado funcional ECOG igual o mayor de 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. |
- Mujeres embarazadas o lactantes. - Pacientes que hayan finalizado 2 o más tratamientos previos de quimioterapia citotóxica. - Los pacientes no deberán tener programada ninguna quimioterapia ni/o radioterapia durante las 12 semanas de tratamiento. - Que se hayan sometido a cirugía mayor (la colocación de un acceso venoso central y las biopsias tumorales no se consideran cirugía mayor) en las 4 semanas previas a la inclusión en el estudio de extensión. Los pacientes deben haberse recuperado totalmente de los efectos inmediatos de la cirugía antes del screening. Los pacientes no deberán tener programado someterse a una cirugía mayor durante el período de tratamiento. - Pacientes que no sean capaces de tragar comprimidos orales con facilidad. Se excluyen los pacientes con afección gastrointestinal grave (incluida la esofagitis, gastritis, malabsorción o síntomas obstructivos) o con vómitos frecuentes o resistentes al tratamiento. - Que presente metástasis cerebrales conocidas o sintomáticas. |
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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 HT-ANAM-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 |
1. Cambios del peso corporal producidos desde el inicio de los ensayos clínicos HT-ANAM-301 o HTANAM-302. 2. Cambio de la Fuerza de Prensión Manual de la mano no dominante. 3. Cambio de la Fuerza de Prensión Manual de la mano dominante. 4. Calidad de vida. |
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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. Cambios del peso corporal en las Semanas 4, 8 y 12. 2. Cambio de la Fuerza de Prensión Manual de la mano no dominante en las Semanas 8 y 12. 3. Cambio de la Fuerza de Prensión Manual de la mano dominante en las Semanas 8 y 12. 4. Calidad de vida medida mediante la FACIT-F y la FAACT en las Semanas 4, 8 y 12. |
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E.5.2 | Secondary end point(s) |
No secondary endpoints specified. All endpoints listed above as primary are the efficacy endpoints for the study |
No hay criterios de valoración secundarios. Todos los criterios de valoración indicados arriba son los parámetros de eficacia para el estudio. |
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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 | 6 |
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 |
Belgium |
Canada |
Czech Republic |
France |
Germany |
Hungary |
Israel |
Italy |
Netherlands |
Poland |
Russian Federation |
Spain |
United Kingdom |
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
|
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). |
Se realizará una visita de seguimiento a los 28 días (±7 days) después de la última dosis del fármaco del estudio para evaluar los acontecimientos adversos. El paciente continuará en el seguimiento de la supervivencia del ensayo clínico inicial en el que participaba (HT-ANAM-301 or HT-ANAM-302) |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |