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Combination Chemotherapy With Nintedanib / Placebo in Endometrial Cancer

NCT02730416 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2025-07-29

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • North Eastern German Society of Gynaecological Oncology

    collaborator OTHER

  • Belgian Gynaecological Oncology Group

    collaborator OTHER

  • ARCAGY/ GINECO GROUP

    collaborator OTHER

  • Nordic Society of Gynaecological Oncology - Clinical Trials Unit

    lead OTHER

Principal Investigators

  • Mansoor R Mirza, MD · NSGO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-12
Primary Completion
2021-10-20
Completion
2021-11-25

Countries

  • Belgium
  • Denmark
  • Finland
  • France
  • Germany
  • Norway
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02730416 on ClinicalTrials.gov