A Phase I Study of LEE011 in Asian Patients
- Registration Number
- NCT01898845
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study will evaluate safety and tolerability to estimate the MTD and/or recommended dose for expansion.
- Detailed Description
This is a multi-center, open label, dose finding, phase I study of oral single agent LEE011, administered once daily.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
- Patient with a histologically confirmed diagnosis of a solid tumor
- ECOG PS <2
- Good organ function at screening visit
- A sufficient interval mast have elapsed between the last dose of prior anti-cancer therapy
- Impairment of GI function
- Patients with concurrent severe and/or uncontrolled concurrent medical conditions
- Known diagnosis of HIV or active viral hepatitis
- Pregnant or nursing (lactating) women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LEE011 LEE011 LEE011
- Primary Outcome Measures
Name Time Method Maximum tolerated dose (MTD) and/or recomended dose (RD) First cycle (28 days) Incidence of dose limiting toxicities (DLTs) First cycle (28 days)
- Secondary Outcome Measures
Name Time Method Overall response rate every 2 months until 28 days after end of treatment To assess preliminaly anti-tumor activity based on RECIST
PK parameters of LEE011 every week up to first 4 weeks, once a week in the subsequent 2 weeks Concentration of LEE011 and PK parameters (e.g. Cmax and AUC)
Progression-free survival every 2 months until 28 days after end of treatment To assess preliminaly anti-tumor activity based on RECIST
Disease control rate every 2 months until 28 days after end of treatment To assess preliminaly anti-tumor activity based on RECIST
Duration of response every 2 months until 28 days after end of treatment To assess preliminaly anti-tumor activity based on RECIST
Overall response every 2 months until 28 days after end of treatment To assess preliminaly anti-tumor activity based on RECIST
Safety and Tolerability of LEE011 from informed consent till 28 days after end of treatment Assessed by incidence, duration and severity of adverse events and serious adverse events; changes in clinical laboratory values, vital signs and ECGs; tolerability of study drug (dose interruption, dose reduction)
Best overall response every 2 months until 28 days after end of treatment To assess preliminaly anti-tumor activity based on RECIST
Trial Locations
- Locations (1)
Novartis Investigative Site
🇯🇵Chuo-ku, Tokyo, Japan