Current partner codePEPTIDESDE
NCT05161195·Phase 4·INTERVENTIONAL

Roll-over Study to Allow Continued Access to Ribociclib

Status

Active, not recruiting

Phase

Phase 4

Enrollment

134

Locations

73

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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).

Full detailed description

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. This roll-over study will not include a screening phase, participants will directly transfer at the completion of the parent study. Eligible participants will start receiving ribociclib in combination with other drugs (as per parent protocol) only after they have signed the Informed Consent and have met the selection criteria for this roll-over study. Participants should return to the study center for resupply of the study medication and for safety and clinical benefit assessment, at a minimum, every 24 weeks, or more frequently at any given time required as per local practice.

Interventions

Treatment arms and agents.

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

Timeline

From registration to results.

  1. First posted

    Dec 17, 2021

  2. Study start

    Jul 7, 2022

  3. Primary completion

    Jun 28, 2030

  4. Study completion

    Aug 14, 2030

  5. Results posted

    Not reported

  6. Registry updated

    Jun 23, 2026

Outcomes

What the study measures.

Primary outcomes

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

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

Clinical benefit rate

Time frame · Up to 8 years

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
100 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

73 registered sites.

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) · United States · Vietnam. Showing up to 24 locations stored in the fast local snapshot.

Ironwood Cancer and Research Centers

Chandler, Arizona, United States

Highlands Oncology Group

Fayetteville, Arkansas, United States

Beverly Hills Cancer Center

Beverly Hills, California, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

Mid Florida Hematology And Onc Ctr

Orange, Florida, United States

Summit Cancer Care

Savannah, Georgia, United States

John D Archbold Memorial Hospital

Thomasville, Georgia, United States

Duly Health and Care

Plainfield, Illinois, United States

Indian Univ Health Goshen Center forCancer

Goshen, Indiana, United States

Northern Light Mercy Hospital

Portland, Maine, United States

Englewood Health

Englewood, New Jersey, United States

The Valley Hospital-Luckow Pavillion

Paramus, New Jersey, United States

Eastchester Center for Cancer Care

The Bronx, New York, United States

University Hospitals of Cleveland Seidman Cancer Center

Cleveland, Ohio, United States

Oklahoma Cancer Specialists and Research Institute

Tulsa, Oklahoma, United States

Millennium Research Clin Develop

Houston, Texas, United States

Novartis Investigative Site

San Juan, Argentina

Novartis Investigative Site

Natal, Rio Grande do Norte, Brazil

Novartis Investigative Site

Ijuí, Rio Grande do Sul, Brazil

Novartis Investigative Site

Florianópolis, Santa Catarina, Brazil

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Novartis Investigative Site

Sao Jose Rio Preto, Brazil

Novartis Investigative Site

São Paulo, Brazil

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Goserelin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.