A Phase I Study of LEE011 in Asian Patients

Study Overview
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Brief Summary
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This study will evaluate safety and tolerability to estimate the MTD and/or recommended dose for expansion.

Detailed Description
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This is a multi-center, open label, dose finding, phase I study of oral single agent LEE011, administered once daily.

Official Title
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A Phase I Study of LEE011 in Asian Patients With Advanced Solid Tumors

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Drug: LEE011


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LEE011<br>LEE011 | Drug: LEE011<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of dose limiting toxicities (DLTs) |  | First cycle (28 days) | 
| Maximum tolerated dose (MTD) and/or recomended dose (RD) |  | First cycle (28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability of LEE011 | 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) | from informed consent till 28 days after end of treatment | 
| PK parameters of LEE011 | Concentration of LEE011 and PK parameters (e.g. Cmax and AUC) | every week up to first 4 weeks, once a week in the subsequent 2 weeks | 
| Best overall response | To assess preliminaly anti-tumor activity based on RECIST | every 2 months until 28 days after end of treatment | 
| Overall response rate | To assess preliminaly anti-tumor activity based on RECIST | every 2 months until 28 days after end of treatment | 
| Progression-free survival | To assess preliminaly anti-tumor activity based on RECIST | every 2 months until 28 days after end of treatment | 
| Disease control rate | To assess preliminaly anti-tumor activity based on RECIST | every 2 months until 28 days after end of treatment | 
| Duration of response | To assess preliminaly anti-tumor activity based on RECIST | every 2 months until 28 days after end of treatment | 
| Overall response | To assess preliminaly anti-tumor activity based on RECIST | every 2 months until 28 days after end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoplasms