A Phase I Study of LEE011 in Asian Patients

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01898845
• Other study ID #: CLEE011X1101
• Status: Completed
• Phase: Phase 1
• Start date: May 2013
• Est. completion date: January 2015

Study information

• Verified date: July 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• LEE011

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Chuo-ku	Tokyo
Japan	Novartis Investigative Site	Kashiwa	Chiba

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Doi T, Hewes B, Kakizume T, Tajima T, Ishikawa N, Yamada Y. Phase I study of single-agent ribociclib in Japanese patients with advanced solid tumors. Cancer Sci. 2018 Jan;109(1):193-198. doi: 10.1111/cas.13428. Epub 2017 Nov 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose limiting toxicities (DLTs)		First cycle (28 days)
Primary	Maximum tolerated dose (MTD) and/or recomended dose (RD)		First cycle (28 days)
Secondary	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
Secondary	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
Secondary	Best overall response	To assess preliminaly anti-tumor activity based on RECIST	every 2 months until 28 days after end of treatment
Secondary	Overall response rate	To assess preliminaly anti-tumor activity based on RECIST	every 2 months until 28 days after end of treatment
Secondary	Progression-free survival	To assess preliminaly anti-tumor activity based on RECIST	every 2 months until 28 days after end of treatment
Secondary	Disease control rate	To assess preliminaly anti-tumor activity based on RECIST	every 2 months until 28 days after end of treatment
Secondary	Duration of response	To assess preliminaly anti-tumor activity based on RECIST	every 2 months until 28 days after end of treatment
Secondary	Overall response	To assess preliminaly anti-tumor activity based on RECIST	every 2 months until 28 days after end of treatment

External Links

•   Results for CLEE011X1101 can be found on the Novartis Clinical Trial Results Website