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
- Conditions
- Neoplasms, Breast Neoplasms, Head and Neck Neoplasms
- Interventions
- Registration Number
- NCT02051751
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BYL719 and paclitaxel BYL719 All patients enrolled in the study will receive BYL719 once daily plus weekly paclitaxel BYL719 and paclitaxel Paclitaxel All patients enrolled in the study will receive BYL719 once daily plus weekly paclitaxel
- Primary Outcome Measures
Name Time Method Dose escalation : Dose Limiting Toxicity (DLT) Cycle 1 (28 days) A dose-limiting toxicity (DLT) is an adverse event or abnormal laboratory value assessed as being unrelated to disease, disease progression, inter-current illness, or concomitant medications, and that occurs within the first cycle of treatment with BYL719 plus paclitaxel and meets any of the pre-defined criteria.
Dose expansion : Number of patients with adverse events as a measure of safety and tolerability Screening, every 28 days until 30 days after last dose type, intensity, severity and seriousness of adverse events according to the NCI CTC AE v4.03. Dose interruptions, reductions and dose intensity.
- Secondary Outcome Measures
Name Time Method Dose escalation : BYL719 and Paclitaxel Plasma concentrations Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 8, Cycle 1 Day 9 Plasma concentration time profiles of BYL719 and paclitaxel. Plasma PK parameters of paclitaxel (single agent vs. combination) and BYL719 (steady state in combination with paclitaxel).
Dose expansion: Clinical benefit Rate in the breast cancer cohort Baseline, every 8 weeks (Breast cancer patients) from start of treatment until first documented disease progression up to 2 years Clinical benefit rate is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) for more than 24 weeks of duration of response.
Dose expansion : Duration of Response Baseline, every 6 weeks (HNSCC patients) or every 8 weeks (breast cancer patients) from start of treatment until first documented disease progression up to 2 years Duration of response is defined as the time of first occurrence of CR or PR until the date of the first documented disease progression or death due to the disease.
Dose expansion: Plasma pharmacokinetics of BYL719 given in combination with paclitaxel in breast cancer and HNSCC patients Cycle 1 Day 1, Cycle 1 Day 8, Cycle 2 Day 15, and Day 1 of each subsequent Cycle Plasma concentration time profiles of BYL719 and appropriate individual PK parameters.
Dose escalation:Number of patients with adverse events as a measure of safety and tolerability Screening, every 28 days until 30 days after last dose type, intensity, severity and seriousness of adverse events according to the NCI CTC AE v4.03. Dose interruptions, reductions and dose intensity.
Dose expansion: Overall response rate Baseline, every 6 weeks (HNSCC patients) or every 8 weeks (Breast cancer patients) from start of treatment until first documented disease progression up to 2 years Overall response rate is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR), based on RECIST 1.1 criteria and the investigator assessment.
Dose expansion: Progression free survival Baseline, every 6 weeks (head-and-neck squamous cell carcinoma (HNSCC) patients) or every 8 weeks (Breast cancer patients) from start of treatment until first documented disease progression up to 2 years Progression-free survival is defined as the time from start date of study treatment until objective tumor progression or death from any cause
Trial Locations
- Locations (3)
Novartis Investigative Site
🇪🇸Barcelona, Catalunya, Spain
Horizon Oncology Center BioAdvance
🇺🇸Lafayette, Indiana, United States
Highlands Oncology Group
🇺🇸Fayetteville, Arkansas, United States