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Cancer patients get continued access to promising drug

NCT ID NCT02934568

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study allows people with advanced cancers who are already benefiting from the drug ribociclib in a previous Novartis trial to keep receiving it. The goal is to provide continued access and monitor how long they stay on treatment and any side effects. Only 22 patients are enrolled, and they must be getting clinical benefit as judged by their doctor.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ribociclib (LEE011)
What this could lead to
If successful, this study allows patients with advanced cancers to keep receiving a treatment that is already working for them, potentially extending their benefit.
What could go wrong
This is a small rollover study (22 patients) with no control group, so results may not apply broadly. Side effects like liver issues or serious adverse events are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

22 people

The number who actually took part.

Started

Dec 2016

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Continued access to study treatment(S), cancers with A mass, bulky tumor, nodule, lump, advanced cancer, advanced solid tumors, advanced solid malignancies

Contacts and locations

Locations

  • Broome Oncology

    Johnson City, New York, 13790, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Novartis Investigative Site

    Lyon, 69373, France

  • Novartis Investigative Site

    Villejuif, 94800, France

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Novartis Investigative Site

    Singapore, 119228, Singapore

  • Novartis Investigative Site

    Madrid, 28041, Spain

  • Novartis Investigative Site

    Madrid, 28050, Spain

  • Novartis Investigative Site

    Tainan, 704302, Taiwan

  • Novartis Investigative Site

    Taipei, 10002, Taiwan

  • St Jude Childrens Research Hospital

    Memphis, Tennessee, 38105, United States

  • The Regents of the Uni of Michigan

    Ann Arbor, Michigan, 48109-5930, United States

  • University Of Alabama At Birmingham

    Birmingham, Alabama, 35294-3300, United States

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