Overview

A Double Blind, Placebo Controlled, Randomized Phase II Study Evaluating Gemcitabine With or Without Ramucirumab , for II Line Treatment MPM

Status:
Active, not recruiting

Trial end date:
2020-12-22

Target enrollment:

Participant gender:

Summary

Study RAMES is a multicentre, double-blind, randomized Phase II study exploring the efficacy and evaluating the safety of the addition of ramucirumab to gemcitabine as the second-line treatment of patients with diffuse pleural mesothelioma. Patients will be randomly assigned (1:1) to receive intravenous gemcitabine 1000 mg/m2 on days 1 and 8 every 21 days with placebo or combined with intravenous ramucirumab 10 mg/Kg (ramucirumab group) on day 1 of a 21 day cycle until PD. Randomisation will be done via a centralized system and will stratified by performance status (0-1 vs 2), age (≤70 vs >70), histology (epithelioid vs others), time to progression (TTP) after a previous treatment (first line therapy, adjuvant or neoadjuvant therapy) (< 6 months vs ≥6 months).

Phase:

Phase 2

Details

Lead Sponsor:

Gruppo Oncologico Italiano di Ricerca Clinica

Treatments:

Antibodies, Monoclonal
Gemcitabine
Ramucirumab