Calendario›TCRT›Carboplatin

Carboplatin

Study of Palifosfamide-tris in Combination With Carboplatin and Etoposide in Chemotherapy Naïve Patients With Extensive-Stage Small Cell Lung Cancer (The MATISSE Study)

Ensayo de Alaunos Therapeutics, Inc. en Extensive-Stage Small Cell Lung Cancer (del registro, en inglés).

Fase

Fase 3

Estado

Interrumpido

Participantes

188

previstos

Centros

79

Fin del objetivo primario

dic 2014

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en jun 2012.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Sponsor closed enrollment in April 2013 following a change in the palifosfamide development plan (business decision), not for safety reasons. Enrolled participants continued treatment and were followed for survival».

Lo que ha cambiado

Movimientos registrados desde que PivotalWire vigila este ensayo. Un retraso no se anuncia: se ve comparando, y esto es la comparación ya hecha.

Qué mide

Overall Survival (OS) (Assessed every 12 weeks for survival until 1 year following completion of enrollment) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a multinational, multicenter, randomized controlled, open-label, adaptive study to evaluate the efficacy of palifosfamide-tris, carboplatin and etoposide (PaCE) chemotherapy in chemotherapy-naive subjects with extensive-stage small cell lung cancer (SCLC). Eligible subjects will be stratified according to age, gender, and Eastern Cooperative Oncology Group (ECOG) performance status, and randomized in a 1:1 ratio to receive either PaCE or carboplatin and etoposide (CE) chemotherapy. The study design uses an adaptive group sequential approach with sample size re-estimation at the interim analysis. Secondary efficacy endpoints include objective response rate (ORR), progression-free survival (PFS), duration of response and changes in quality of life (QOL) and disease-related symptoms. Tumor-related endpoints will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines. The safety of study treatments will be assessed by the frequency and severity of adverse events as determined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03. To provide an initial confirmation of safety, an early interim analysis of safety data only will be performed. An independent Data Monitoring Committee (DMC) will be convened to assess the safety and efficacy of the study interventions and to monitor the overall conduct of the clinical trial.

Más ensayos de TCRT

Todos los de TCRT, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01555710), actualizada en sep 2026.