Study to Evaluate the Safety and Efficacy of Everolimus, in Subjects With PIK3CA Amplification, PTEN Loss and PIK3CA Mutation Refractory Solid Tumors

Summary

This study is a single-arm, phase II study of everolimus in patients with PTEN loss ,PIK3CA mutation and PIK3CA amplification Refractory Solid Tumors . Everolimus 10 mg will be administered orally qd daily. To investigate the efficacy and safety of everolimus in patients with PTEN loss ,PIK3CA mutantion and PIK3CA amplification Refractory Solid Tumors.

Timeline

Start

2015-02

Primary completion

2016-04

Completion

2016-08

Outcome

Missed primary endpoint

paper The study did not meet its primary objective of demonstrating the anti-tumor activity of everolimus PMID 28330462 ↗

Publications

• Kim ST, Lee J, Park SH, Park JO, Park YS, Kang WK, Lim HY. Prospective phase II trial of everolimus in PIK3CA amplification/mutation and/or PTEN loss patients with advanced solid tumors refractory to standard therapy. BMC Cancer. 2017 Mar 23;17(1):211. doi: 10.1186/s12885-017-3196-6.

Drugs

Indications