A Phase I Study of LEE011 in Asian Patients

Novartis

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: LEE011

Study type: Interventional

Funder types: Industry

Identifiers

NCT01898845

CLEE011X1101

Details and patient eligibility

About

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

Full description

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

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

LEE011

Experimental group

Description:

LEE011

Treatment:

Drug: LEE011