Clinical Trial: Lenvatinib in Second Line Endometrial Carcinoma

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: A Randomized Phase II Study of Lenvatinib Versus Doxorubicin in Second Line Advanced or Recurrent Endometrial Carcinoma

Brief Summary:

The primary objective of this multicenter, randomized phase II trial is to assess the efficacy, as measured by progression-free survival (PFS), of lenvatinib compared to doxorubicin in advanced or recurrent endometrial cancer.

The main secondary objective is to evaluate the predictive value of Ang-2 on lenvatinib activity and establishing a cutoff value as potential selection criteria for phase III.

Other secondary objectives are to assess the tolerability and safety of lenvatinib in this setting and overall survival, response and disease control.


Detailed Summary:
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Current Primary Outcome: Progression free survival (PFS) [ Time Frame: 2.5 years ]

PFS assessed by Response Evaluation Criteria in Solid Tumors (RECIST


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: European Organisation for Research and Treatment of Cancer - EORTC

Dates:
Date Received: August 18, 2016
Date Started: January 2017
Date Completion:
Last Updated: December 23, 2016
Last Verified: December 2016