Clinical trial NCT02934568: Ribociclib (LEE011) Rollover Study for Continued Access
Official title: An Open-label, Multi-center Rollover Protocol for Patients Who Have Participated in a Novartis-sponsored Ribociclib (LEE011) Study and Are Continuing to Benefit From Ribociclib as Single Agent or in Combination With Other Investigational Treatments
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid Malignancies
Keywords: Ribociclib
LEE011
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2016-10-17
Enrollment: 50
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: Number of Patients enrolled and received LEE011
timeFrame: up to 5 years (study duration)
measure: Length of time receiving study treatment
timeFrame: up to 5 years (study duration)
Secondary outcomes:
measure: Frequency and nature of adverse events (AEs), serious adverse events (SAEs), non-fatal SAEs and liver function assays.
timeFrame: up to 5 years (study duration)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Of Alabama At Birmingham
state: Alabama
city: Boston
country: United States
facility: Dana Farber Cancer Institute Main Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: The Regents of the University of Michigan
state: Michigan
city: Johnson City
country: United States
facility: Broome Oncology SC-2
state: New York
city: Memphis
country: United States
facility: St Jude Childrens Research Hospital
state: Tennessee
city: Lyon
country: France
facility: Novartis Investigative Site
city: Villejuif
country: France
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Tainan
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
Study officials:
References: