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Trial · Interventional

Active, not recruitingPhase 4Registry data

Roll-over Study to Allow Continued Access to Ribociclib

NCTNCT05161195 (opens ClinicalTrials.gov in a new tab)Other idCLEE011A2412BOther id2024-514891-41-00
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Active, not recruiting
Phase
Phase 4
Enrollment
134 participants (actual)
Sponsor
Novartis Pharmaceuticals · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
22 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

Start
7 Jul 2022
Primary completion
28 Jun 2030 (estimated)
Completion
14 Aug 2030 (estimated)
First posted
17 Dec 2021
Last update posted
19 Oct 2026
Conditions
Metastatic Breast Cancer

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20222024202620282030
  1. Ph 4

    Roll-over Study to Allow Continued Access to Ribociclib

    NCT05161195

    7 Jul 2022 to est. 14 Aug 2030

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • RibociclibDrug
  • LetrozoleDrug
  • AnastrozoleDrug
  • GoserelinDrug
  • TamoxifenDrug
  • FulvestrantDrug

Arms1

  • Other

    Ribociclib

    Participants will receive ribociclib with other drugs at the same dose and schedule as in the parent study. Treatment continues until clinical benefit ends (e.g., disease progression), unacceptable toxicity, consent withdrawal, protocol non-compliance, transition to alternative therapy or access program, can receive ribociclib through prescription (commercially availability and reimbursement of ribociclib except for U.S. participants from CLEE011A2404).

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage of participants with treatment-emergent adverse events (AES)

    Time frame · From day of first dose of study medication to 30 days after last dose of study medication, up to 8 years

    Registry description

    The percentage of participants with treatment-emergent adverse events will be summarized, including significant adverse events leading to discontinuation, and adverse events leading to dose adjustment

Secondary outcomes(1)

  1. Clinical benefit rate

    Time frame · Up to 8 years

    Registry description

    Percentage of participants with clinical benefit as assessed by the Investigator at scheduled study visits

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 100 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Key Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * Participant is 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). * Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures. * Participant must have been receiving treatment with ribociclib for at least 6 cycles in the parent study. * Participant must have evidence of clinical benefit as determined by the Investigator. Key Exclusion Criteria: * Permanent discontinuation of ribociclib in the parent study due to toxicity or disease progression, non-compliance to study procedures, withdrawal of consent or any other reason as stipulated in parent protocol. * Participant currently has unresolved toxicities for which ribociclib dosing has been interrupted in the parent study (participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow ribociclib dosing to resume). * Local access to commercially available ribociclib and reimbursed (except for US enrolled participants from parent protocol CLEE011A2404 meeting all other eligibility criteria). * Women of child-bearing potential defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study treatment and for 21 days after stopping the treatment. Highly effective contraception methods include: 1. Total abstinence 2. Female sterilization 3. Male partner sterilization 4. Placement of an intrauterine device (IUD) * Male contraception during ribociclib use by male participants is not required unless it is necessary due to the safety profile of other medications a participant is taking or by local regulations. Other protocol-defined inclusion/exclusion criteria may apply.

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