Safety and Efficacy of Buparlisib (BKM120) in Patients With Untreated Squamous Non-small Cell Lung Cancer

Summary

The Phase Ib part of the study aimed to determine the maximum tolerated dose/recommended Phase II dose (MTD/RP2D) of once daily buparlisib in combination with every-three-week carboplatin and paclitaxel in patients with previously untreated metastatic squamous NSCLC. The purpose of the Phase II portion of the study was to assess the treatment effect of adding buparlisib versus buparlisib-matching placebo to every-three-week carboplatin and paclitaxel on progression free survival (PFS) in patients with previously untreated metastatic squamous NSCLC.

Timeline

Start

2013-09-09

Primary completion

2014-06-18

Completion

2014-06-18

Outcome

Missed primary endpoint

Stopped: “Due to DLTs/AEs safety profile considered challenging.”

paper BASALT-1 did not meet its primary objective during Stage 1. PMID 26098748 ↗

Publications

• Vansteenkiste JF, Canon JL, De Braud F, Grossi F, De Pas T, Gray JE, Su WC, Felip E, Yoshioka H, Gridelli C, Dy GK, Thongprasert S, Reck M, Aimone P, Vidam GA, Roussou P, Wang YA, Di Tomaso E, Soria JC. Safety and Efficacy of Buparlisib (BKM120) in Patients with PI3K Pathway-Activated Non-Small Cell Lung Cancer: Results from the Phase II BASALT-1 Study. J Thorac Oncol. 2015 Sep;10(9):1319-1327. doi: 10.1097/JTO.0000000000000607.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Buparlisib	Small molecule	100 mg	—
Background	Carboplatin	Small molecule	—	—
Background	Paclitaxel	Small molecule	—	—

Indications