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Ribociclib (LEE011) Rollover Study for Continued Access

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02934568
Recruitment Status : Active, not recruiting
First Posted : October 17, 2016
Last Update Posted : November 3, 2022
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid Malignancies Drug: LEE011 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multi-center Rollover Protocol for Patients Who Have Participated in a Novartis-sponsored Ribociclib (LEE011) Study and Are Continuing to Benefit From Ribociclib as Single Agent or in Combination With Other Investigational Treatments
Actual Study Start Date : December 15, 2016
Estimated Primary Completion Date : September 3, 2024
Estimated Study Completion Date : September 3, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Ribociclib

Arm Intervention/treatment
Experimental: LEE011
All patients in all combinations with LEE011 will be entered in one arm.
Drug: LEE011
Single agent LEE011 or in combination with other treatments

Primary Outcome Measures :
  1. Number of Patients enrolled and received LEE011 [ Time Frame: up to 5 years (study duration) ]
    Continued access to study treatment as a single agent or in combination with other investigational treatments until patients discontinue study

  2. Length of time receiving study treatment [ Time Frame: up to 5 years (study duration) ]
    Assessed by duration in days from start of study treatment until study treatment discontinuation

Secondary Outcome Measures :
  1. Frequency and nature of adverse events (AEs), serious adverse events (SAEs), non-fatal SAEs and liver function assays. [ Time Frame: up to 5 years (study duration) ]
    The data include only AEs that started or worsened during the on-treatment-period, the treatment-emergent AEs.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02934568

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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300
United States, Massachusetts
Dana Farber Cancer Institute Main Site
Boston, Massachusetts, United States, 02215
United States, Michigan
The Regents of the University of Michigan
Ann Arbor, Michigan, United States, 48109-5930
United States, New York
Broome Oncology SC-2
Johnson City, New York, United States, 13790
United States, Tennessee
St Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Novartis Investigative Site
Villejuif Cedex, Villejuif, France, 94800
Novartis Investigative Site
Lyon Cedex, France, 69373
Novartis Investigative Site
Singapore, Singapore, 119228
Novartis Investigative Site
Madrid, Spain, 28041
Novartis Investigative Site
Madrid, Spain, 28050
Novartis Investigative Site
Tainan, Taiwan, 70403
Novartis Investigative Site
Taipei, Taiwan, 10002
Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02934568    
Other Study ID Numbers: CLEE011X2X01B
First Posted: October 17, 2016    Key Record Dates
Last Update Posted: November 3, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Additional relevant MeSH terms:
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