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Clinical Trials in Spain / NCT02934568
Active, not recruiting Phase 2

Ribociclib (LEE011) Rollover Study for Continued Access

NCT02934568 · tracked via the Priya Life Science Spain tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 2
Started
2016-12-15
Last updated
2026-04-16

Condition(s) studied

Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid Malignancies

Investigational drug(s) / intervention(s)

LEE011 →

LEE011: Single agent LEE011 or in combination with other treatments

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.

Eligibility

Sex
ALL
Min age
0 Years
Max age
80 Years
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.

Primary outcome measure(s)

  • Number of Patients enrolled and received LEE011 — 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
  • Length of time receiving study treatment — up to 5 years (study duration)
    Assessed by duration in days from start of study treatment until study treatment discontinuation

Trial sites (13)

FacilityCityRegionStatus
University Of Alabama At Birmingham Birmingham Alabama
Dana Farber Cancer Institute Boston Massachusetts
The Regents of the Uni of Michigan Ann Arbor Michigan
Broome Oncology Johnson City New York
St Jude Childrens Research Hospital Memphis Tennessee
Novartis Investigative Site Lyon France
Novartis Investigative Site Villejuif France
Novartis Investigative Site Cologne North Rhine-Westphalia
Novartis Investigative Site Singapore Singapore
Novartis Investigative Site Madrid Spain
Novartis Investigative Site Madrid Spain
Novartis Investigative Site Tainan Taiwan
Novartis Investigative Site Taipei Taiwan

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A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis (ALS) Active, not recruiting
Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02934568 on ClinicalTrials.gov ↗ ← All trials in Spain