A phase 2 trial of buparlisib in patients with platinum-resistant metastatic urothelial carcinoma.

ABSTRACT:

Background

The phosphatidyl 3-inositol kinase (PI3K)/Akt/mechanistic target of rapamycin (mTOR) pathway frequently is activated in patients with urothelial carcinoma (UC). In the current study, the authors performed a phase 2 study evaluating the efficacy of the pan-isoform class I PI3K inhibitor buparlisib in patients with platinum-refractory metastatic UC.

Methods

Two cohorts were recruited: an initial genetically unselected cohort and a subsequent expansion cohort of patients with PI3K/Akt/mTOR pathway-altered tumors. The primary endpoint was the 2-month progression-free survival rate. A rate of ≥80% was considered promising using a Simon 2-stage minimax design. Secondary endpoints included safety and correlation of markers of PI3K pathway activation with outcome.

Resu

SUBMITTER: McPherson V 

PROVIDER: S-EPMC8356147 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature