NCT03560973

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

A Double-blind, Placebo Controlled, Randomized Multicenter Phase II Study Evaluating Gemcitabine With or Without Ramucirumab as II Line Treatment for Advanced Malignant Pleural Mesothelioma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Mesothelioma

Interventions

Type	Name	Description
DRUG	Gemcitabine	ramucirumab/ placebo was added to gemcitabine
DRUG	Ramucirumab	ramucirumab/ placebo was added to gemcitabine

Timeline

• Start date: 2016-12-22
• Primary completion: 2018-07-30
• Completion: 2022-07-20
• First posted: 2018-06-19
• Last updated: 2025-03-13

Locations

1 site across 1 country: Italy