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Roll-over Study to Allow Continued Access to Ribociclib

NCT05161195 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2026-04-02

No results posted yet for this study

Summary

The purpose of this study is to assess the long-term safety of ribociclib (LEE011) in combination with other drugs and provide post-trial access (PTA) to participants who are currently receiving treatment with ribociclib in combination with other drugs and continuing to have clinical benefit in a Novartis-sponsored global study that has reached its primary objective(s).

Conditions

Interventions

DRUG

Ribociclib

Participants continue ribociclib as was administered in their parent study

DRUG

Letrozole

Participants continue ribociclib in combination with letrozole as was administered in their parent study

DRUG

Anastrozole

Participants continue ribociclib in combination with anastrozole as was administered in their parent study

DRUG

Goserelin

Participants continue ribociclib in combination with goserelin as was administered in their parent study

DRUG

Tamoxifen

Participants continue ribociclib in combination with tamoxifen as was administered in their parent study

DRUG

Fulvestrant

All participants continue ribociclib in combination with fulvestrant as was administered in their parent study

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-07
Primary Completion
2030-06-28
Completion
2030-08-14
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • China
  • Costa Rica
  • Greece
  • Hong Kong
  • India
  • Italy
  • Japan
  • Lebanon
  • Mexico
  • Peru
  • Poland
  • Portugal
  • Singapore
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05161195 on ClinicalTrials.gov