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NCT02934568 · ClinicalTrials.gov registry record · Phase 2

Ribociclib (LEE011) Rollover Study for Continued Access

A Phase 2 study of Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid Malignancies, sponsored by Novartis Pharmaceuticals.

Active
Registry status
Phase 2
Development phase
22
Enrollment target
13
Study locations

NCT02934568: Active Phase 2 study of Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid Malignancies, sponsored by Novartis Pharmaceuticals.

NCT02934568 is a Phase 2 study of Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid Malignancies that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). The trial reports 13 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02934568, a Phase 2 study of Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid Malignancies, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
22 participants
Enrollment target
13
Study locations

Study 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.

Primary Outcome

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

Interventions

  • DRUG LEE011

Study Locations (13)

Other

  • Novartis Investigative Site - Lyon
  • Novartis Investigative Site - Villejuif
  • Novartis Investigative Site - Singapore
  • Novartis Investigative Site - Madrid
  • Novartis Investigative Site - Madrid
  • Novartis Investigative Site - Tainan
  • Novartis Investigative Site - Taipei

Alabama

  • University Of Alabama At Birmingham - Birmingham

Massachusetts

  • Dana Farber Cancer Institute - Boston

Michigan

  • The Regents of the Uni of Michigan - Ann Arbor

New York

  • Broome Oncology - Johnson City

Tennessee

  • St Jude Childrens Research Hospital - Memphis

North Rhine-Westphalia

  • Novartis Investigative Site - Cologne

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2016-12-15
Est. Completion 2027-02-01
Phase Phase 2
Novartis Pharmaceuticals

1,375 total trials

What the registry record for NCT02934568 still lists

NCT02934568 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).

The record links to 1 condition, with Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid Malignancies appearing as the primary indexed condition, and to 1 intervention - of which LEE011 is the first listed.

NCT02934568 lists 13 locations in 7 states (Other, Alabama, Massachusetts).

Frequently Asked Questions

What is clinical trial NCT02934568 about?

NCT02934568 is a clinical study titled "Ribociclib (LEE011) Rollover Study for Continued Access". 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 othe...

What is the current status of trial NCT02934568?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2016-12-15. Estimated completion is 2027-02-01.

What conditions does trial NCT02934568 study?

This clinical trial studies the following conditions: Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid Malignancies.

What interventions are being tested in trial NCT02934568?

The interventions under investigation include: LEE011 (DRUG).

Who is sponsoring clinical trial NCT02934568?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02934568 being conducted?

This trial has 13 study locations across Alabama, Massachusetts, Michigan, New York, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT02934568's enrollment target sits among peer trials

22 1790th of 2000 higher than 207 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02934568, the US trial registry maintained by the National Library of Medicine. NCT02934568 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.