← Back to Search

Continued Access to Ribociclib for Solid Cancers

Memphis, TN
Phase 2
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is currently enrolled in an eligible Novartis-sponsored study and receiving ribociclib (LEE011) as single agent or in combination with other investigational treatment
Must not have
Patient has been permanently discontinued from ribociclib (LEE011) in the parent protocol for any reason
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years (study duration)
Awards & highlights
No Placebo-Only Group

Summary

This trial is to see if patients who benefitted from ribociclib in other studies can continue to take it as a single agent or in combination with other drugs.

See full description
Who is the study for?
This trial is for patients already participating in a Novartis-sponsored study using ribociclib (LEE011) alone or with other experimental treatments. They must be seeing positive results as judged by their doctor, and meet the original study's ongoing criteria.Check my eligibility
What is being tested?
The trial provides continued access to ribociclib (LEE011), either on its own or combined with other investigational drugs, for those who have benefited from it in previous Novartis studies that are now complete or stopped.See study design
What are the potential side effects?
Ribociclib may cause side effects like low white blood cell counts which can lead to infection risk, liver problems, fatigue, nausea, hair loss and headache. The exact side effects can vary based on whether it's taken alone or with other treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am currently in a Novartis study and taking ribociclib alone or with other treatments.
 show original

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I was taken off ribociclib treatment for any reason.
 show original

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years (study duration)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years (study duration) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Length of time receiving study treatment
Number of Patients enrolled and received LEE011
Secondary study objectives
Frequency and nature of adverse events (AEs), serious adverse events (SAEs), non-fatal SAEs and liver function assays.

Side effects data

From 2024 Phase 2 trial • 21 Patients • NCT03070301
95%
Hyperglycemia
76%
Leukopenia
76%
Thrombocytopenia
71%
Anemia
67%
Fatigue
67%
Neutropenia
48%
Lymphocytopenia
38%
Mucositis oral
33%
Increased creatinine
33%
Rash maculo-papular
24%
Diarrhea
24%
Fever
19%
Peripheral edema
19%
Hypokalemia
19%
Epistaxis
19%
Edema Limbs
14%
Increased cholesterol
14%
Insomnia
14%
Increased AST
14%
Hypocalcemia
14%
Headache
14%
Hypomagnesemia
10%
Nausea
10%
Upper respiratory infection
10%
Nasal congestion
10%
Hypoglycemia
10%
Hypertriglyceridemia
10%
Pruritus
10%
Hypophosphatemia
10%
Flatulence
10%
Abdominal pain
10%
Anorexia
10%
Arthralgia
10%
Dry Skin
5%
Fall
5%
Pneumonitis
5%
Death NOS
5%
Flu like symptoms
5%
Small intestinal obstruction
5%
Febrile Neutropenia
5%
Urinary tract infection
5%
Cough
5%
Dyspnea
5%
Seizure
5%
Vomiting
5%
Febrile neutropenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
LEE011 and Everolimus

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: LEE011Experimental Treatment1 Intervention
All patients in all combinations with LEE011 will be entered in one arm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LEE011
2014
Completed Phase 2
~1290

Find a Location

Closest Location:The Regents of the University of Michigan· Ann Arbor, MI· 166 miles
Image of The Regents of the University of Michigan in Ann Arbor, United States.Image of The Regents of the University of Michigan in Ann Arbor, United States.Image of The Regents of the University of Michigan in Ann Arbor, United States.

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,957 Previous Clinical Trials
4,273,336 Total Patients Enrolled

Media Library

Ribociclib (LEE011) Clinical Trial Eligibility Overview. Trial Name: NCT02934568 — Phase 2
Solid Tumors Research Study Groups: LEE011
Solid Tumors Clinical Trial 2023: Ribociclib (LEE011) Highlights & Side Effects. Trial Name: NCT02934568 — Phase 2
Ribociclib (LEE011) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02934568 — Phase 2
~7 spots leftby Aug 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top