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Continued Access to Ribociclib for Solid Cancers

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years (study duration)

Awards & highlights

Study 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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years (study duration)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Length of time receiving study treatment

Number of Patients enrolled and received LEE011

Secondary outcome measures

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

Side effects data

From 2023 Phase 3 trial • 668 Patients • NCT01958021

61%

NEUTROPENIA

51%

NAUSEA

37%

FATIGUE

35%

DIARRHOEA

33%

ALOPECIA

28%

VOMITING

27%

ARTHRALGIA

24%

CONSTIPATION

22%

HEADACHE

21%

HOT FLUSH

20%

BACK PAIN

19%

COUGH

19%

NEUTROPHIL COUNT DECREASED

19%

WHITE BLOOD CELL COUNT DECREASED

18%

ANAEMIA

18%

DECREASED APPETITE

17%

RASH

15%

ALANINE AMINOTRANSFERASE INCREASED

15%

ASPARTATE AMINOTRANSFERASE INCREASED

15%

LEUKOPENIA

14%

HYPERTENSION

13%

PRURITUS

13%

ASTHENIA

12%

DIZZINESS

12%

PYREXIA

12%

INSOMNIA

12%

OEDEMA PERIPHERAL

12%

STOMATITIS

11%

DYSPNOEA

10%

DRY MOUTH

10%

PAIN IN EXTREMITY

10%

UPPER RESPIRATORY TRACT INFECTION

10%

URINARY TRACT INFECTION

ABDOMINAL PAIN

DYSGEUSIA

MUSCULOSKELETAL PAIN

DRY SKIN

ANXIETY

DEPRESSION

NASOPHARYNGITIS

MYALGIA

BLOOD CREATININE INCREASED

DYSPEPSIA

LACRIMATION INCREASED

BONE PAIN

THROMBOCYTOPENIA

WEIGHT DECREASED

OROPHARYNGEAL PAIN

ABDOMINAL PAIN UPPER

LYMPHOCYTE COUNT DECREASED

DRY EYE

INFLUENZA

MUSCULOSKELETAL CHEST PAIN

INFLUENZA LIKE ILLNESS

VERTIGO

HYPERGLYCAEMIA

HYPOCALCAEMIA

BREAST PAIN

NON-CARDIAC CHEST PAIN

BLOOD ALKALINE PHOSPHATASE INCREASED

MUSCLE SPASMS

ASCITES

HYPOTENSION

DEHYDRATION

HEPATIC FAILURE

FEBRILE NEUTROPENIA

SYNCOPE

MENTAL STATUS CHANGES

FEMUR FRACTURE

CHOLECYSTITIS

GENERAL PHYSICAL HEALTH DETERIORATION

HEPATOTOXICITY

SEPSIS

PLEURAL EFFUSION

PULMONARY EMBOLISM

PNEUMONIA

100%

80%

60%

40%

20%

Study treatment Arm

Ribociclib 600mg + Letrozole 2.5mg

Placebo + Letrozole 2.5mg

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 3

~1960

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,859 Previous Clinical Trials

4,198,194 Total Patients Enrolled

Media Library

LEE011 Clinical Trial Eligibility Overview. Trial Name: NCT02934568 — Phase 2

Solid Tumors Research Study Groups: LEE011

Solid Tumors Clinical Trial 2023: LEE011 Highlights & Side Effects. Trial Name: NCT02934568 — Phase 2

LEE011 2023 Treatment Timeline for Medical Study. Trial Name: NCT02934568 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this research been done before?

"LEE011 was first trialled in 2012 by pharmaceutical company Pfizer. After the initial study, which had 189 participants, LEE011 was approved for Phase 1 & 2 drugs. As of now, there are 54 ongoing clinical trials in 565 cities and 56 countries."

Answered by AI

Are there any dangerous side-effects associated with taking LEE011?

"LEE011 received a 2 because, although there is some data supporting its safety, none of it suggests that the medication is effective."

Answered by AI

Does this research project still have room for more participants?

"Unfortunately, this particular trial is not seeking any more participants at the moment. It was initially posted on December 15th, 2016 and updated for the last time on November 2nd, 2022. However, there are over 2500 other trials that potential patients can participate in."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ribociclib (LEE011) Rollover Study for Continued Access

2016. "Ribociclib (LEE011) Rollover Study for Continued Access". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02934568.