Roll-over Study to Allow Continued Access to Ribociclib

Sponsor: Novartis Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05161195

Patient View

This open-label, multi-center study evaluates the long-term safety of ribociclib in combination with other drugs for participants from a Novartis global study who have completed primary objectives and show clinical benefit. Eligible participants must have received ribociclib for at least 6 cycles. Interventions include ribociclib with letrozole, anastrozole, goserelin, tamoxifen, or fulvestrant.

Patient Parameters

Program Overview

This is an open-label, multi-center, roll-over study to evaluate the long term safety of ribociclib in combination with other drugs in participants who are participating in a Novartis sponsored global study, that has fulfilled requirements for its primary objective(s), and who in the opinion of the Investigator, would benefit from continued treatment.

Description

The purpose of this study is to evaluate long-term safety and provide continued treatment to participants who are currently receiving ribociclib in combination with other drugs in a parent study, that has fulfilled requirements for its primary objective(s), and in the opinion of the Investigator, would benefit from continuing treatment at time of discontinuation from the parent study

Eligibility Criteria

Inclusion Criteria

  1. Currently participating in a Novartis sponsored global study (parent study), receiving treatment with ribociclib in combination with other drugs, and the parent study has fulfilled its primary objective(s)
  2. Must have been receiving treatment with ribociclib for at least 6 cycles in the parent study
  3. Currently has evidence of clinical benefit as determined by the Investigator

Key

Exclusion Criteria

  1. Permanent discontinuation of ribociclib in the parent study
  2. Currently has unresolved toxicities for which ribociclib dosing has been interrupted in the parent study 3. Local access to commercially available ribociclib and reimbursed

Other protocol-defined inclusion/exclusion criteria may apply at the end

Get This Program In Your Inbox

You can sign up and apply your patients for this program.