Ribociclib (LEE011) Rollover Study for Continued Access

Phase 2

Recruiting

• Conditions: Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid Malignancies
• Interventions: Drug: LEE011

• Registration Number: NCT02934568
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-10
• Study First Submitted QC: 2016-10-13
• Study First Posted: 2016-10-17
• Study Start: 2016-12-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-26
• Primary Completion: 2026-08-31
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LEE011	LEE011	All patients in all combinations with LEE011 will be entered in one arm.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Frequency and nature of adverse events (AEs), serious adverse events (SAEs), non-fatal SAEs and liver function assays.	up to 5 years (study duration)	The data include only AEs that started or worsened during the on-treatment-period, the treatment-emergent AEs.

Trial Locations

Locations (6)

Novartis Investigative Site; 🇨🇳 Taipei, Taiwan

University Of Alabama At Birmingham; 🇺🇸 Birmingham, Alabama, United States

Dana Farber Cancer Institute Main Site; 🇺🇸 Boston, Massachusetts, United States

The Regents of the University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Broome Oncology SC-2; 🇺🇸 Johnson City, New York, United States

St Jude Childrens Research Hospital; 🇺🇸 Memphis, Tennessee, United States