Ribociclib (LEE011) Rollover Study for Continued Access

Phase 2Active Not RecruitingNCT02934568

Novartis Pharmaceuticals22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

LEE011DRUG

Single agent LEE011 or in combination with other treatments

Eligibility

Sex: ALLMin age: 0 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (13)

University Of Alabama At Birmingham

Birmingham, Alabama, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

The Regents of the Uni of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Number of Patients enrolled and received LEE011

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

Time frame: up to 5 years (study duration)

Length of time receiving study treatment

Assessed by duration in days from start of study treatment until study treatment discontinuation

Time frame: up to 5 years (study duration)

Secondary Outcomes

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

The data include only AEs that started or worsened during the on-treatment-period, the treatment-emergent AEs.

Time frame: up to 5 years (study duration)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.