A Study to Evaluate the Potential Benefit of the Addition of BYL719 to Paclitaxel in the Treatment of Breast Cancer and Head-and-neck Cancer

NCT02051751 ↗

Phase 1 Completed 19 enrolled Novartis Pharmaceuticals

NaSingle-groupOpen-labelTreatment

Summary

Dose escalation part:to determine the highest dose of BYL719 administered on a daily basis when given in combination with weekly paclitaxel Dose escalation part: to confirm the safety and tolerability of the BYL719 and paclitaxel combination

Timeline

Start: 2014-03-05
Primary completion: 2016-08-19
Completion: 2016-08-19

Publications

Rodon J, Curigliano G, Delord JP, Harb W, Azaro A, Han Y, Wilke C, Donnet V, Sellami D, Beck T. A Phase Ib, open-label, dose-finding study of alpelisib in combination with paclitaxel in patients with advanced solid tumors. Oncotarget. 2018 Aug 3;9(60):31709-31718. doi: 10.18632/oncotarget.25854. eCollection 2018 Aug 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alpelisib	Small molecule	150 mg	Oral
Subject	Alpelisib	Small molecule	250 mg	Oral
Subject	Alpelisib	Small molecule	300 mg	Oral
Background	Paclitaxel	Small molecule	80 mg/m2	Intravenous

A Study to Evaluate the Potential Benefit of the Addition of BYL719 to Paclitaxel in the Treatment of Breast Cancer and Head-and-neck Cancer

Summary

Timeline

Publications

Drugs

Indications