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Clinical Trials/NCT01898845
NCT01898845CompletedPhase 1

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

Novartis Pharmaceuticals1 site in 1 country17 target enrollmentStarted: May 2013Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
17
Locations
1
Primary Endpoint
Incidence of dose limiting toxicities (DLTs)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Detailed Description

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

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

LEE011

Experimental

LEE011

Intervention: LEE011 (Drug)

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

  • Overall response rate(every 2 months until 28 days after end of treatment)
  • Progression-free survival(every 2 months until 28 days after end of treatment)
  • Disease control rate(every 2 months until 28 days after end of treatment)
  • Duration of response(every 2 months until 28 days after end of treatment)
  • Overall response(every 2 months until 28 days after end of treatment)
  • Safety and Tolerability of LEE011(from informed consent till 28 days after end of treatment)
  • PK parameters of LEE011(every week up to first 4 weeks, once a week in the subsequent 2 weeks)
  • Best overall response(every 2 months until 28 days after end of treatment)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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