Combination Chemotherapy With Nintedanib / Placebo in Endometrial Cancer

Status Completed

Clinical Trial Summary

This study will evaluate the role of addition of an anti-angiogenic agent (Nintedanib/placebo) to conventional combination chemotherapy as concomitant and maintenance treatment in primary advanced or with first relapse of endometrial cancer.

Clinical Trial Description

This multicenter, prospective, double-blind, placebo-controlled, randomised phase 2 study is evaluating combination chemotherapy with nintedanib in patients with primary advanced stage (3C2 & 4), or with first relapse of endometrial cancer. Patients are stratified according to: 1. Stage of disease (stage 3C2 vs. stage 4 vs. recurrent disease) 2. Prior adjuvant chemotherapy (yes/no) 3. Disease status (Measurable disease vs. non-measurable /RECIST 1.1) Patients are randomized to one of the two treatment arms 1:1 randomization: - Arm A: Paclitaxel and Carboplatin (6 courses) and Nintedanib (until PD). (Experimental arm) - Arm B: Paclitaxel and Carboplatin (6 courses) and Placebo (until PD) (Control Arm) Primary endpoint is PFS. 148 patients to be enrolled. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02730416
Study type	Interventional
Source	Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Contact
Status	Completed
Phase	Phase 2
Start date	December 12, 2016
Completion date	November 25, 2021

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