- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01898845
A Phase I Study of LEE011 in Asian Patients
December 16, 2020 updated by: Novartis Pharmaceuticals
A Phase I Study of LEE011 in Asian Patients With Advanced Solid Tumors
This study will evaluate safety and tolerability to estimate the MTD and/or recommended dose for expansion.
Study Overview
Detailed Description
This is a multi-center, open label, dose finding, phase I study of oral single agent LEE011, administered once daily.
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Chiba
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Kashiwa, Chiba, Japan
- Novartis Investigative Site
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Tokyo
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Chuo-ku, Tokyo, Japan
- Novartis Investigative Site
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LEE011
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of dose limiting toxicities (DLTs)
Time Frame: First cycle (28 days)
|
First cycle (28 days)
|
Maximum tolerated dose (MTD) and/or recomended dose (RD)
Time Frame: First cycle (28 days)
|
First cycle (28 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and Tolerability of LEE011
Time Frame: 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)
|
from informed consent till 28 days after end of treatment
|
PK parameters of LEE011
Time Frame: 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)
|
every week up to first 4 weeks, once a week in the subsequent 2 weeks
|
Best overall response
Time Frame: every 2 months until 28 days after end of treatment
|
To assess preliminaly anti-tumor activity based on RECIST
|
every 2 months until 28 days after end of treatment
|
Overall response rate
Time Frame: every 2 months until 28 days after end of treatment
|
To assess preliminaly anti-tumor activity based on RECIST
|
every 2 months until 28 days after end of treatment
|
Progression-free survival
Time Frame: every 2 months until 28 days after end of treatment
|
To assess preliminaly anti-tumor activity based on RECIST
|
every 2 months until 28 days after end of treatment
|
Disease control rate
Time Frame: every 2 months until 28 days after end of treatment
|
To assess preliminaly anti-tumor activity based on RECIST
|
every 2 months until 28 days after end of treatment
|
Duration of response
Time Frame: every 2 months until 28 days after end of treatment
|
To assess preliminaly anti-tumor activity based on RECIST
|
every 2 months until 28 days after end of treatment
|
Overall response
Time Frame: every 2 months until 28 days after end of treatment
|
To assess preliminaly anti-tumor activity based on RECIST
|
every 2 months until 28 days after end of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
July 1, 2013
First Submitted That Met QC Criteria
July 10, 2013
First Posted (Estimate)
July 12, 2013
Study Record Updates
Last Update Posted (Actual)
December 19, 2020
Last Update Submitted That Met QC Criteria
December 16, 2020
Last Verified
July 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CLEE011X1101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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