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

Phase 1

• Conditions: different types of advanced cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-000293-37-FR
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-30
• Last Update Posted: 6 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified