A rollover study for patients who have participated in a Novartis-sponsored ribociclib (LEE011) study and are continuing to benefit from ribociclib alone or in combination with other agents

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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000293-37-ES

Enrollment

Registered

2016-09-26

Start date

2016-12-05

Completion date

Unknown

Last updated

2016-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

different types of advanced cancer

Interventions

Product Name: LEE011 Product Code: LEE011 Pharmaceutical Form: Capsule INN or Proposed INN: ribociclib Other descriptive name: LEE011 Concentration unit: mg milligram(s) Concentration type: equal Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patient is currently enrolled in an eligible Novartis-sponsored ribociclib (LEE011) study and is receiving ribociclib as single agent or in combination with other investigational treatments. - Patient is currently deriving clinical benefit from the study treatment, as determined by the investigator. - Patient has demonstrated compliance, as assessed by the investigator, with the parent protocol requirements. Are the trial subjects under 18? yes Number of subjects for this age range: 2 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 19 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 19

Exclusion criteria

Exclusion criteria: - Patients who have permanently discontinued from ribociclib (LEE011) in the parent protocol for any reason. - Patients who do not meet parent protocol criteria to continue study treatment.

Design outcomes

Primary

Measure	Time frame
Main Objective: To allow patients enrolled in a LEE011 Novartis-sponsored study continued access to study treatment after the study has reached its primary objective(s) or the study has been terminated for other reasons.;Secondary Objective: To collect safety data for ribociclib as single agent or in combination with other investigational treatments.;Primary end point(s): Number of patients receiving ribociclib as single agent or in combination with other investigational treatments under the rollover study, duration of exposure;Timepoint(s) of evaluation of this end point: continuous	—

Measure

Time frame

Main Objective: To allow patients enrolled in a LEE011 Novartis-sponsored study continued access to study treatment after the study has reached its primary objective(s) or the study has been terminated for other reasons.;Secondary Objective: To collect safety data for ribociclib as single agent or in combination with other investigational treatments.;Primary end point(s): Number of patients receiving ribociclib as single agent or in combination with other investigational treatments under the rollover study, duration of exposure;Timepoint(s) of evaluation of this end point: continuous

—

Secondary

Measure	Time frame
Secondary end point(s): Frequency and nature of adverse events (AEs), serious adverse events (SAE),& liver function tests;Timepoint(s) of evaluation of this end point: continuous	—

Countries

France, Spain, United States

Contacts

Public ContactDepartamento Médico Oncología (GMO)

Novartis Farmacéutica, S.A.

eecc.novartis@novartis.com+34900353036

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026