Status:
COMPLETED
A Phase I Study of LEE011 in Asian Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01898845
Start Date
May 1 2013
End Date
January 1 2015
Last Update
December 19 2020
Active Locations (2)
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1
Novartis Investigative Site
Kashiwa, Chiba, Japan
2
Novartis Investigative Site
Chuo-ku, Tokyo, Japan