Gastrointestinal Agents

All Drugs and Chemicals

Lactitol

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

Single agent LEE011 or in combination with other treatments

LEE011

Novartis Pharmaceuticals

Kelley Booten

Giles Robinson

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.

Ribociclib (LEE011) Rollover Study for Continued Access

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

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Ribociclib (LEE011) Rollover Study for Continued Access	NCT02934568	Continued Acces...	LEE011	- 80 Years	Novartis
Ribociclib (LEE011) Rollover Study for Continued Access	NCT02934568	Continued Acces...	LEE011	- 80 Years	Novartis

Spots Global Cancer Trial Database for continued access to study treatment(s), cancers with a mass, bulky tumor, nodule, lump, advanced cancer, advanced solid tumors, advanced solid malignancies