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Completed

NCT Number: NCT01898845

A Phase I Study of LEE011 in Asian Patients

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

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Key information

Conditions

Advanced Solid Tumors Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Kashiwa, Chiba, Japan

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LEE011

Drug

Primary outcomes

  1. Incidence of dose limiting toxicities (DLTs)

    Time frame: First cycle (28 days)

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

    Time frame: First cycle (28 days)

Secondary outcomes

  1. 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)

  2. 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)

  3. Best overall response

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

    To assess preliminaly anti-tumor activity based on RECIST

  4. Overall response rate

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

    To assess preliminaly anti-tumor activity based on RECIST

  5. Progression-free survival

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

    To assess preliminaly anti-tumor activity based on RECIST

  6. Disease control rate

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

    To assess preliminaly anti-tumor activity based on RECIST

  7. Duration of response

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

    To assess preliminaly anti-tumor activity based on RECIST

  8. Overall response

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

    To assess preliminaly anti-tumor activity based on RECIST

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 12, 2013
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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