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A Multicenter, Open-Label, Randomized, Phase 2 Study to Evaluate the Efficacy and Safety of NKTR-102 (PEG-Irinotecan) Versus Irinotecan in Patients with Second-Line, Irinotecan-Naïve, KRAS-Mutant, Colorectal Cancer with Metastatic or Locally Advanced Disease. Estudio de fase II, Aleatorizado, Abierto, Multicéntrico para Evaluar la Eficacia y Seguridad de NKTR-102 (Irinotecán-PEG) Frente a Irinotec...

ABSTRACT: Primary objectives: To estimate the progression-free survival (PFS) with NKTR-102 versus irinotecan. Primary endpoints: The primary endpoint of this study is progression-free survival (PFS), which is defined as the time from the date of randomization to the date of progressive disease (PD), death due to any cause, premature removal from the study due to unacceptable toxicity or the initiation of new therapy.

DISEASE(S): Malignant Solid Tumor,Refractory Solid Tumors (colorectal Cancer) tumores Sólidos Refractarios (cáncer Colorrectal),Colorectal Cancer,Refractory Solid Tumors (colorectal Cancer)tumores Sólidos Refractarios (cáncer Colorrectal)

PROVIDER: 2524788 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:PURPOSE:Etirinotecan pegol (NKTR-102) is a unique, long-acting topoisomerase-I inhibitor with prolonged systemic exposure to SN38 (7-ethyl-10-hydroxycamptothecin), the active metabolite of irinotecan. This randomized phase II trial investigated two dosing schedules of etirinotecan pegol in patients with platinum-resistant/refractory ovarian carcinoma. PATIENTS AND METHODS:A total of 71 eligible patients were randomly assigned to receive etirinotecan pegol 145 mg/m(2) every 14 or 21 days until progression or unacceptable adverse events (AEs). The primary end point was objective response rate (ORR) by RECIST (version 1.0). Secondary end points included response by Gynecologic Cancer Intergroup criteria, duration of ORR, progression-free survival (PFS), and overall survival (OS). RESULTS:The overall confirmed ORR was 20% (95% CI, 10% to 30%): 20% for once every 14 days, and 19% for once every 21 days. Median response duration was 4.1 months for once every 14 days and 4.0 months for once every 21 days. Median PFS for every 14 and every 21 days was 4.1 and 5.3 months, respectively, and median OS was 10.0 and 11.7 months, respectively. Etirinotecan pegol was well tolerated, with the most common grade 3 to 4 AEs being dehydration (24%) and diarrhea (23%). Diarrhea, dehydration, nausea, and neutropenia were less frequent with the schedule of once every 21 days than with that of once every 14 days. CONCLUSION:Both schedules of etirinotecan pegol showed activity in patients with heavily pretreated ovarian cancer, with encouraging ORR and PFS rates. The schedule of once every 21 days was better tolerated and had slightly longer PFS and OS rates. The treatment schedule of etirinotecan pegol 145 mg/m(2) once every 21 days was selected for the expanded phase II study and is preferred for future phase III studies. These findings provide support to directly compare etirinotecan pegol versus one of the approved drugs (eg, pegylated liposomal doxorubicin or topotecan) in platinum-resistant ovarian cancer.

Project description:Introducción La Organización Mundial de la Salud (OMS) recomienda las intervenciones tempranas de rehabilitación y movilización en pacientes hospitalizados por COVID-19. Los beneficios de la fisioterapia precoz, durante la estancia hospitalaria, no han sido probados en ensayos clínicos. Objetivo Evaluar los efectos de la fisioterapia precoz y educación para la salud en pacientes COVID-19 hospitalizados, en relación con los síntomas descritos en estudios previos, analizando diferencias entre grupos respecto a su acondicionamiento físico, necesidad de oxigenoterapia y estancia hospitalaria. Metodología Ensayo clínico aleatorizado con dos brazos, desarrollado en unidades de hospitalización y cuidados respiratorios intermedios (UCRI), con pacientes COVID-19. Se incluyeron 64 sujetos en el grupo experimental (implementación de un programa de fisioterapia precoz tras 48-72 horas de ingreso) y 62 en el grupo control (tratamiento habitual del centro). Variables sociodemográficas y clínicas: escala de disnea modified Medical Research Council (Mmrc), oxigenoterapia, Medical Research Council Scale sum score (MRC-SS), 30 segundos sit to stand test (30 s-STST), fuerza de prensión manual (FPM), Tinetti, escala de fragilidad (FRAIL-España) y escala Post-COVID-19Functional Status (PCFS). Se evaluaron al ingreso, al alta y a los dos meses del alta. Resultados Los experimentales tuvieron menos días de ingreso y de oxigenoterapia convencional. Al alta, presentan menor riesgo de caída (72,9 vs. 95,8%) y menor debilidad en MRC-SS (2,1 vs. 14,6%). A los dos meses tenían menor fragilidad (5,0 vs. 14,5%), mayor fuerza de prensión manual, menos disnea, mejores resultados en 30s-STST y menos limitaciones post-COVID (86,5 vs. 96,4%). Conclusión La intervención de fisioterapia precoz en pacientes COVID-19 y la educación para la salud recibida previenen la debilidad muscular durante el ingreso, mejoran el acondicionamiento físico al alta y a los dos meses y disminuyen los días de estancia hospitalaria. ClinicalTrials.gov (NCT05032885).

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