NCT02730416

Combination Chemotherapy With Nintedanib / Placebo in Endometrial Cancer

ENGOT-EN1/FANDANGO: A Randomized Phase II Trial of First-line Combination Chemotherapy With Nintedanib / Placebo for Patients With Advanced or Recurrent Endometrial Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Nordic Society of Gynaecological Oncology - Clinical Trials Unit · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	Nintedanib or Placebo; Carboplatin, Paclitaxel	Arm A: Nintedanib: 200mg orally twice daily d 2-21 q 21 days x 6 courses; afterwards daily dosing, until PD Arm B: Placebo: orally twice daily d 2-21 q 21 days x 6 courses; afterwards daily dosing, until PD In both arms: 6 courses of standard carboplatin and paclitaxel: Carboplatin AUC 5 iv every 21 days; Paclitaxel 175mg/m2 iv every 21 days. Both drugs are continued for maximum six courses or until unacceptable toxicity

Timeline

• Start date: 2016-12-12
• Primary completion: 2021-10-20
• Completion: 2021-11-25
• First posted: 2016-04-06
• Last updated: 2025-07-29

Locations

37 sites across 7 countries: Belgium, Denmark, Finland, France, Germany, Norway, Sweden