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

PHASE1CompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

March 5, 2014

Primary Completion Date

August 19, 2016

Study Completion Date

August 19, 2016

Conditions
Neoplasms, Breast Neoplasms, Head and Neck Neoplasms
Interventions
DRUG

BYL719

BYL719 will be administered orally once daily on a continuous dosing schedule and dosed on a flat-fixed dose and not adjusted by body weight or body surface area, starting on Day 2 in the dose escalation part and Day 1 in the dose expansion part. In the dose escalation part, the BYL719 starting dose will be 300mg, with anticipated dose escalation to 350mg. In the dose expansion part, BYL719 will be administered at the recommended dose determined in the dose escalation part.

DRUG

Paclitaxel

Paclitaxel will be administered once weekly at a dose of 80 mg/m2 i.v. (days 1, 8, 15 and 22) in a 28 day cycle in both dose escalation and expansion.

Trial Locations (5)

20141

Novartis Investigative Site, Milan

31059

Novartis Investigative Site, Toulouse

47905

Horizon Oncology Center BioAdvance, Lafayette

72703

Highlands Oncology Group, Fayetteville

08035

Novartis Investigative Site, Barcelona

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY