An Open Label, Non Randomized, Multicenter Phase 1/2b Study Investigating Safety and Efficacy of PQR309 and Eribulin Combination in Patients With Locally Advanced or Metastatic HER2 Negative and Triple-Negative Breast Cancer

简要总结

详细描述

主要结局

次要结局

• Physical examination, Body weight in kg(up to 12 months)
• Number and percent of patients having each ECOG (Eastern Oncology Cooperative Group) performance status level will be presented for baseline and each post-baseline measurement.(up to 12 months)
• PK parameters of PQR309 and eribulin will include: AUC0-∞(PK is being assessed during Cycle 1 on Day 8: pre-dose, end of eribulin infusion, 2h and 6h post end of eribulin infusion. On Cycle 1 Day 15: pre-dose and one sample between 1 and 3 hours post PQR309 dose.)
• Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: RAC(PK is being assessed during Cycle 1 on Day 8: pre-dose, end of eribulin infusion, 2h and 6h post end of eribulin infusion. On Cycle 1 Day 15: pre-dose and one sample between 1 and 3 hours post PQR309 dose.)
• Changes in Insulin levels(12 months)
• Assessment of PQR309 and Eribulin blood concentration(up to 12 months)
• Objective Response Rate (ORR), is defined as the best overall response (confirmed CR or PR) recorded for each patient since baseline.(up to 12 months)
• 1-year survival, defined as the time from study entry to death as a result of any cause at 1-year cut-off date(up to 12 months)
• Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: tmax(It will be measured pre-dose and at the end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end and at end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end of eribulin during Cycle 1 on day 1 and 8 and beyond cycle 1 on day 1)
• Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: cmax(It will be measured pre-dose and at the end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end and at end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end of eribulin during Cycle 1 on day 1 and 8 and beyond cycle 1 on day 1)
• Number of patients with Adverse Events and Serious Adverse Events and number of anormal laboratory values that constitute an Adverse Events on their own(Up to 12 months)
• Physical examination, ECG(up to 12 months)
• Vital signs like body temperature(up to 12 months)
• Time to Response (TTR) is defined, for patients with tumor response, as the time from the date of study entry to the first documentation of response (complete or partial)(up to 12 months)
• Time to treatment failure (TTF) is defined as the time from study entry to any treatment failure including disease progression or discontinuation of treatment(up to 12 months)
• Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: AUC0-∞(It will be measured pre-dose and at the end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end and at end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end of eribulin during Cycle 1 day on 1 and 8 and beyond cycle 1 on day 1)
• Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: t1/2(It will be measured pre-dose and at the end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end and at end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end of eribulin during Cycle 1 on day 1 and 8 and beyond cycle 1 on day 1)
• Changes of Routine laboratory -Haematology(12 months)
• Changes of Routine laboratory -urinanalysis(12 months)
• Vital signs like heart rate(up to 12 months)
• Vital signs like blood pressure(up to 12 months)
• Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: AUC0-24(It will be measured pre-dose and at the end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end and at end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end of eribulin during Cycle 1 on day 1 and 8 and beyond cycle 1 on day 1)
• Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: RAC(Racemate)(On Cycle 1 Day 8: pre-dose, end of eribulin infusion, 2h and 6h post end of eribulin infusion and on Day 15: pre-dose and one sample between 1 and 3 hours post PQR309 dose)
• Changes of Routine laboratory -blood chemistry(12 months)
• Duration of response (DOR) is defined, for the patients with tumor response, as the time from the date of the first confirmed response to disease progression.(up to 12 months)
• Progression- free survival (PFS) is defined as the time from study entry to progression or death due to any cause(up to 12 months)
• Changes in glucose levels(12 months)
• Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: RAC (Racemate)(It will be measured pre-dose and at the end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end and at end of eribulin infusion and 0.5h, 1h, 2h, 4h, and 8h post end of eribulin during Cycle 1 on day 1 and 8 and beyond cycle 1 on day 1)