Roll-over Study to Allow Continued Access to Ribociclib

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05161195
Phase
PHASE4
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Ribociclib — DRUG
    Participants continue ribociclib as was administered in their parent study
  • Letrozole — DRUG
    Participants continue ribociclib in combination with letrozole as was administered in their parent study
  • Anastrozole — DRUG
    Participants continue ribociclib in combination with anastrozole as was administered in their parent study
  • Goserelin — DRUG
    Participants continue ribociclib in combination with goserelin as was administered in their parent study
  • Tamoxifen — DRUG
    Participants continue ribociclib in combination with tamoxifen as was administered in their parent study
  • Fulvestrant — DRUG
    All participants continue ribociclib in combination with fulvestrant as was administered in their parent study

Study Details

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).

Key Dates

Start date
Jul 7, 2022
Status verified
Jun 2026
Primary completion
Jun 28, 2030
Completion
Aug 14, 2030

Study Design

Enrollment
134 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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 Outcome Measure

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 ]

Locations (16)

FacilityCityStateZIPSite coordinators
Ironwood Cancer and Research CentersChandlerArizona85224-
Highlands Oncology GroupFayettevilleArkansas72703-
Beverly Hills Cancer CenterBeverly HillsCalifornia90211-
Poudre Valley HospitalFort CollinsColorado80528-
Mid Florida Hematology And Onc CtrOrangeFlorida32763-
Summit Cancer CareSavannahGeorgia31405-
John D Archbold Memorial HospitalThomasvilleGeorgia31792-
Duly Health and CarePlainfieldIllinois60585-
Indian Univ Health Goshen Center forCancerGoshenIndiana46526-
Northern Light Mercy HospitalPortlandMaine04102-
Englewood HealthEnglewoodNew Jersey07631-
The Valley Hospital-Luckow PavillionParamusNew Jersey07652-
Eastchester Center for Cancer CareThe BronxNew York10469-
University Hospitals of Cleveland Seidman Cancer CenterClevelandOhio44106-
Oklahoma Cancer Specialists and Research InstituteTulsaOklahoma74136-
Millennium Research Clin DevelopHoustonTexas77090-

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By research site
Ironwood Cancer and Research Centers· Chandler, AZHighlands Oncology Group· Fayetteville, ARBeverly Hills Cancer Center· Beverly Hills, CAPoudre Valley Hospital· Fort Collins, COMid Florida Hematology And Onc Ctr· Orange, FLSummit Cancer Care· Savannah, GA

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