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

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05796518` - Feasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors	N/A
Recruiting	`NCT05489211` - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)	Phase 2
Active, not recruiting	`NCT03667716` - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.	Phase 1
Active, not recruiting	`NCT03170960` - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors	Phase 1/Phase 2
Not yet recruiting	`NCT06463028` - Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel, Serabelisib With Paclitaxel, and Paclitaxel Alone in Patients With Advanced/Recurrent Endometrial Cancer	Phase 2
Recruiting	`NCT06036836` - Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010)	Phase 2
Terminated	`NCT04586335` - Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.	Phase 1
Completed	`NCT03820024` - MOtiVating Endometrial Cancer Survivors With Activity Monitors and Tailored Feedback	N/A
Active, not recruiting	`NCT05082025` - Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K (PIK3CA, PIK3R1) and/or PTEN Alterations	Phase 2
Active, not recruiting	`NCT00587886` - Estrogen, Diet, Genetics and Endometrial Cancer
Completed	`NCT05378152` - Assessing the Benefit of Pipelle Biopsy in Patients With Postmenopausal Bleeding and an Atrophic-appearing Cavity	N/A
Suspended	`NCT05124743` - HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors
Recruiting	`NCT03876860` - An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis	N/A
Recruiting	`NCT04569773` - Choosing Ovarian Preservation or Removal Before Surgery for Endometrial Cancer
Completed	`NCT04534309` - Behavioral Weight Loss Program for Cancer Survivors in Maryland	N/A
Not yet recruiting	`NCT06366347` - ALPINE: Maintenance Letrozole/Abemaciclib vs Pembrolizumab	Phase 2
Not yet recruiting	`NCT06073184` - Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium	Phase 2
Not yet recruiting	`NCT05998798` - Revealing Engagement Patterns Among Endometrial Cancer Patients
Terminated	`NCT02907073` - Positron Emission Tomography (PET) Imaging Studies With NIS Reporter	Phase 1/Phase 2
Completed	`NCT02413606` - ENdometrial Cancer SURvivors' Follow-up carE (ENSURE): Less is More?	N/A