NCT02934568

Brief Summary

This study is to allow continued use of ribociclib (LEE011) as single agent or in combination with other investigational treatments in patients benefitting from treatment in an eligible Novartis-sponsored ribociclib (LEE011) study that has reached its primary objective(s) or has been halted for other reasons.

Trial Health

82
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
9mo left

Started Dec 2016

Longer than P75 for phase_2

Geographic Reach
6 countries

13 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Dec 2016Feb 2027

First Submitted

Initial submission to the registry

October 10, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 17, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

December 15, 2016

Completed
10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

10.1 years

First QC Date

October 10, 2016

Last Update Submit

April 13, 2026

Conditions

Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid Malignancies

Keywords

RibociclibLEE011

Outcome Measures

Primary Outcomes (2)

  • Number of Patients enrolled and received LEE011

    Continued access to study treatment as a single agent or in combination with other investigational treatments until patients discontinue study

    up to 5 years (study duration)

  • Length of time receiving study treatment

    Assessed by duration in days from start of study treatment until study treatment discontinuation

    up to 5 years (study duration)

Secondary Outcomes (1)

  • Frequency and nature of adverse events (AEs), serious adverse events (SAEs), non-fatal SAEs and liver function assays.

    up to 5 years (study duration)

Study Arms (1)

LEE011

EXPERIMENTAL

All patients in all combinations with LEE011 will be entered in one arm.

Drug: LEE011

Interventions

LEE011DRUG

Single agent LEE011 or in combination with other treatments

LEE011

Eligibility Criteria

Age0 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is currently enrolled in an eligible Novartis-sponsored study and receiving ribociclib (LEE011) as single agent or in combination with other investigational treatment.
  • Patient is currently deriving clinical benefit from the study treatment, as determined by the investigator.

You may not qualify if:

  • Patient has been permanently discontinued from ribociclib (LEE011) in the parent protocol for any reason.
  • Patients who do not meet parent protocol criteria to continue study treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

University Of Alabama At Birmingham

Birmingham, Alabama, 35294-3300, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

The Regents of the Uni of Michigan

Ann Arbor, Michigan, 48109-5930, United States

Location

Broome Oncology

Johnson City, New York, 13790, United States

Location

St Jude Childrens Research Hospital

Memphis, Tennessee, 38105, United States

Location

Novartis Investigative Site

Lyon, 69373, France

Location

Novartis Investigative Site

Villejuif, 94800, France

Location

Novartis Investigative Site

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Novartis Investigative Site

Singapore, 119228, Singapore

Location

Novartis Investigative Site

Madrid, 28041, Spain

Location

Novartis Investigative Site

Madrid, 28050, Spain

Location

Novartis Investigative Site

Tainan, 704302, Taiwan

Location

Novartis Investigative Site

Taipei, 10002, Taiwan

Location

MeSH Terms

Interventions

ribociclib

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

October 10, 2016

First Posted

October 17, 2016

Study Start

December 15, 2016

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

April 16, 2026

Record last verified: 2026-04

Locations

TW(2)ES(2)FR(2)DE(1)SG(1)US(5)