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Study Status: Withdrawn
Recruit Status: Withdrawn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 ]
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