Las Fases I Sirven Para Determinar la Mayor Dosis Que Pueda Darse de Forma Segura de un Nuevo Tratamiento Sin Causar Efectos Secundarios Graves .
Extraño Que a Fecha de Hoy ... Dos de los Hospitales del Ensayo Clínico No Han Incluido Aún a Ningún Paciente .
| ClinicalTrials.gov Identifier: NCT04253145 |
Recruitment Status : Recruiting First Posted : February 5, 2020 Last Update Posted : March 3, 2021 |
Sponsor:
Fundacion Oncosur
Information Provided by (Responsible Party):
Fundacion Oncosur
Brief Summary:
Prospective, open-label, uncontrolled and multicenter phase I-II study in SCLC patients with ECOG PS 0-1 who have failed one prior platinum-containing line but no more than one chemotherapy-containing line. The study will be divided into two parts: a dose-ranging phase I with escalating doses of PM01183 in combination with a fixed dose of atezolizumab, followed by a single-arm phase II part with expansion at the RD determined during the phase I.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Carcinoma, Small Cell Lung | Drug: PM 01183Drug: Atezolizumab | Phase 1 |
Phase I Patients will receive atezolizumab at a fixed dose of 1200 mg intravenously (i.v.) followed by PM01183 at a starting dose of 2.5 mg/m2 i.v. as a 1-hour infusion on Day 1 every three weeks (q3wk). PM01183 doses will be escalated in successive cohorts of patients following a modified Fibonacci scheme and a classical 3+3 design, and according to observed tolerance and safety.
To determine the maximum tolerated dose (MTD) and the recommended dose for phase II studies (RD) of PM01183 in combination with atezolizumab in advanced SCLC patients progressing after platinum doublet chemotherapy.
| Study Type : | Interventional (Clinical Trial) | ||
| Estimated Enrollment : | 25 participants | ||
| Allocation: | N/A | ||
| Intervention Model: | Single Group Assignment | ||
| Intervention Model Description: | Prospective, open-label, uncontrolled and multicenter phase I-II study | ||
| Masking: | None (Open Label) | ||
| Primary Purpose: | Treatment | ||
| Official Title: | Phase I-II Study to Assess the Safety, Tolerability and Efficacy of PM01183 and Atezolizumab in Patients With Advanced Small Cell Lung Cancer That Progressed Following Prior Therapy With Platinum-Based Chemotherapy. | ||
| Actual Study Start Date : | December 13, 2019 | ||
| Estimated Primary Completion Date : | February 2022 | ||
| Estimated Study Completion Date : | February 2022 | Locations |