A Phase I Study of LEE011 in Asian Patients

Phase 1CompletedNCT01898845

Novartis Pharmaceuticals17 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Solid Tumors

Interventions

LEE011DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Novartis Investigative Site

Kashiwa, Chiba, Japan

Novartis Investigative Site

Chuo-ku, Tokyo, Japan

Outcomes

Primary Outcomes

Incidence of dose limiting toxicities (DLTs)

Time frame: First cycle (28 days)

Maximum tolerated dose (MTD) and/or recomended dose (RD)

Time frame: First cycle (28 days)

Secondary Outcomes

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)

Time frame: 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)

Time frame: 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

Time frame: every 2 months until 28 days after end of treatment

Overall response rate

To assess preliminaly anti-tumor activity based on RECIST

Time frame: every 2 months until 28 days after end of treatment

Progression-free survival

To assess preliminaly anti-tumor activity based on RECIST

Time frame: every 2 months until 28 days after end of treatment

Disease control rate

To assess preliminaly anti-tumor activity based on RECIST

Time frame: every 2 months until 28 days after end of treatment

Data from ClinicalTrials.gov

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