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 (NSCLC-C) |
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E.1.1.1 | Medical condition in easily understood language |
Weight-loss and lean body mass loss due to non-small cell lung cancer |
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 |
1. To evaluate the effect of Anamorelin HCl on lean body mass (LBM) as measured by dual energy X-ray absorptiometry (DXA) 2. To evaluate the effect of Anamorelin HCl on muscle strength as measured by handgrip strength (HGS) |
1. Evaluar el efecto de HCl de Anamorelina en la masa corporal magra (MCM), medida mediante absorciometría de rayos X de energía dual (AXD) 2. Evaluar el efecto de HCl de Anamorelina en la fuerza muscular, medida mediante la fuerza de prensión manual (FPM) |
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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 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) 3. To evaluate the effect of Anamorelin HCl on overall survival |
1. Evaluar el efecto de HCl de Anamorelina en el peso corporal 2. Evaluar el efecto de HCl de Anamorelina en la calidad de vida, medida utilizando el FACIT-F (Evaluación función de la fatiga en el tratamiento de la enfermedad crónica) y FAACT (Evaluación funcional del tratamiento de la anorexia/caquexia) 3. Evaluar el efecto de HCl de Anamorelina en la supervivencia general |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
?Females and males at least 18 years of age. ?Documented histologic or cytologic diagnosis of AJCC Stage III or IV NSCLC. Stage III patients must have unresectable disease. ?With regard to chemotherapy and/or radiation therapy: Patients may be receiving maintenance chemotherapy (after first line chemotherapy), Patients may be initiating a new chemotherapy (first or second line) and/or radiation therapy regimen within 7 days of study drug randomization, patients are receiving no chemotherapy and/or radiation for NSCLC. ?Involuntary weight loss of greater than/equal to 5% body weight within 6 months prior to screening or a screening BMI <20 kg/m2. ?Body mass index less than/equal to 30 kg/m2 ?ECOG less than/equal to 2 |
- Mujeres y varones de al menos 18 años de edad. - Diagnóstico de NSCLC en estadio III o IV según la AJCC documentado histológica o citológicamente. Los pacientes en estadio III deberán tener un carcinoma irresecable. - Con respecto a la quimioterapia y/o la radioterapia: Los pacientes pueden estar recibiendo quimioterapia de mantenimiento (después de recibir quimioterapia de primera línea). Los pacientes pueden iniciar un nuevo tratamiento de quimioterapia (de primera o segunda línea) y/o radioterapia entre los 7 días desde el inicio del tratamiento hasta la randomización. Pacientes que no reciben un tratamiento de quimioterapia y/o radioterapia por el NSCLC. - Pérdida de peso involuntaria mayor o igual del 5 % del peso corporal en los 6 meses previos al screening o IMC en el screening < 20 kg/m2. - Índice de masa corporal menor o igual de 30 kg/m2. - Estado funcional ECOG menor o igual 2. |
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E.4 | Principal exclusion criteria |
?Other forms of lung cancer (eg, small cell, mesothelioma). ?Women who are pregnant or breast-feeding. ?Patients who have completed 2 or more prior cytotoxic chemotherapy regimens. ?Had major surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to randomization. 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 gastrointestinal disease (including esophagitis, gastritis, malabsorption, or obstructive symptoms) or intractable or frequent vomiting are excluded. ?Has untreated clinically relevant hypothyroidism. ?Has known or symptomatic brain metastases. |
- Otras formas de carcinomas pulmonares (por ejemplo, microcítico, mesotelioma). - Mujeres embarazadas o lactantes. - Pacientes que hayan finalizado 2 o más tratamientos de quimioterapia citotóxica previos. - 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 randomización. Los pacientes deben haberse recuperado totalmente de los efectos inmediatos de la cirugía antes del screening. Los pacientes no deberán tener programado someterse a 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 hipotiroidismo clínicamente relevante sin tratar. - Que presente metástasis cerebrales conocidas o sintomáticas. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Lean Body Mass change from baseline as measured by DXA 2. Hand Grip Strength of the non-dominant hand change from baseline |
1. Cambio de la masa corporal magra, con respecto a los valores iniciales, mediante AXD. 2. Cambio de la Fuerza de Prensión Manual de la mano no dominante, respecto a los valores iniciales. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Lean Body Mass change from baseline as measured by DXA over 12 weeks. 2. Hand Grip Strength of the non-dominant hand change over 12 weeks. |
1. Cambio de la Masa Corportal Magra, con respecto a los valores iniciales, mediante AXD tras 12 semanas. 2. Cambio de la Fuerza de Prensión Manual de la mano no dominante, respecto a los valores iniciales, tras 12 semanas. |
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E.5.2 | Secondary end point(s) |
1. Percentage change in Lean Body Mass. 2. Percentage change on Hand Grip Strength of the non-dominant hand. 3. Changes in body weight 4. Change in Hand Grip Strength of the dominant hand. 5. Quality of life. 6. Overall survival. . |
1. Cambio porcentual en la Masa Corporal Magra. 2. Cambio porcentual en la Fuerza de Prensión Manual de la mano no dominante. 3. Cambios en el peso corporal. 4. Cambio en la Fuerza de Prensión Manual de la mano dominante. 5. Calidad de vida. 6. Supervivencia general. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Percentage change in Lean Body mass over 12 weeks. 2. Percentage change on Hand Grip Strength of the non-dominant hand over 12 weeks. 3. Changes in body weight at Weeks 3, 6, 9, 12. 4. Change in Hand Grip strength of the dominant hand at Weeks 6, 12. 5. Quality of life as assessed by FAACT and FACIT-F at Weeks 3, 6, 9, 12. 6. Overall survival assessed until death up to 1 year. |
1. Cambio porcentual en la Masa Corporal Magra tras 12 semanas. 2. Cambio porcentual en la Fuerza de Prensión Manual de la mano no dominante tras 12 semanas. 3. Cambios en el peso corporal en las Semanas 3, 6, 9, 12. 4. Cambio en la Fuerza de Prensión Manual de la mano dominante en las Semanas 6, 12. 5. Calidad de vida medida mediante FACIT-F y FAACT en las Semanas 3, 6, 9 y 12. 6. Supervivencia general medida hasta la muerte hasta 1 año. |
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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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
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 | 33 |
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 |
Belgium |
Canada |
Czech Republic |
France |
Germany |
Italy |
Netherlands |
Spain |
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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Patients will be followed for 1 year from randomization (every 3 months) for survival status. Patients who enter the extension study (HT-ANAM-303) will continue to participate in the survival follow-up for this study. |
Se les realizará a los pacientes un seguimiento durante 1 año a partir de la randomización (cada 3 meses) para verificar el estado de supervivencia. Los pacientes que se incluyan en el estudio de extensión (HT ANAM-303) continuarán participando en el seguimiento a largo plazo de la supervivencia de este estudio. |
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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 | 1 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |