Roll-over Study to Allow Continued Access to Ribociclib

Last updated: October 11, 2024
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

4

Condition

Breast Cancer

Metastatic Cancer

Treatment

Anastrozole

Goserelin

Letrozole

Clinical Study ID

NCT05161195
CLEE011A2412B
2021-005184-42
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Key inclusion Criteria:

  1. Currently participating in a Novartis sponsored global study (parent study),receiving treatment with ribociclib in combination with other drugs, and the parentstudy has fulfilled its primary objective(s)

  2. Must have been receiving treatment with ribociclib for at least 6 cycles in theparent study

  3. Currently has evidence of clinical benefit as determined by the Investigator

Exclusion

Key exclusion Criteria:

  1. Permanent discontinuation of ribociclib in the parent study

  2. Currently has unresolved toxicities for which ribociclib dosing has been interruptedin the parent study 3. Local access to commercially available ribociclib andreimbursed

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

Study Design

Total Participants: 137
Treatment Group(s): 6
Primary Treatment: Anastrozole
Phase: 4
Study Start date:
July 07, 2022
Estimated Completion Date:
February 16, 2028

Study 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

Connect with a study center

  • Novartis Investigative Site

    San Juan, J5402DIL
    Argentina

    Active - Recruiting

  • Novartis Investigative Site

    Natal, RN 59075 740
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    Ijui, RS 98700-000
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    Ijuí, RS 98700-000
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Florianopolis, SC 88034-000
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    Sao Paulo, SP 01317 000
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    São Paulo, SP 03102
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Sao Jose do Rio Preto, 15090 000
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    Sao Jose do Rio Preto, 15090 000
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    San Jose, 95008
    Costa Rica

    Active - Recruiting

  • Novartis Investigative Site

    Heraklion Crete, 71110
    Greece

    Site Not Available

  • Novartis Investigative Site

    Hong Kong,
    Hong Kong

    Site Not Available

  • Novartis Investigative Site

    Pokfulam,
    Hong Kong

    Site Not Available

  • Novartis Investigative Site

    Shatin, HONGKONG
    Hong Kong

    Site Not Available

  • Novartis Investigative Site

    Shatin New Territories,
    Hong Kong

    Site Not Available

  • Novartis Investigative Site

    Shatin, New Territories,
    Hong Kong

    Site Not Available

  • Novartis Investigative Site

    Bhubaneshwar, Orissa 751007
    India

    Site Not Available

  • Novartis Investigative Site

    Delhi, 110 085
    India

    Site Not Available

  • Novartis Investigative Site

    Meldola, FC 47014
    Italy

    Site Not Available

  • Novartis Investigative Site

    Osaka-city, Osaka 540-0006
    Japan

    Completed

  • Novartis Investigative Site

    Bunkyo ku, Tokyo 113-8431
    Japan

    Site Not Available

  • Novartis Investigative Site

    Koto ku, Tokyo 135 8550
    Japan

    Site Not Available

  • Novartis Investigative Site

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Novartis Investigative Site

    El Chouf, LBN 1503201002
    Lebanon

    Site Not Available

  • Novartis Investigative Site

    Ashrafieh, 166830
    Lebanon

    Site Not Available

  • Novartis Investigative Site

    Beirut, 1107 2020
    Lebanon

    Site Not Available

  • Novartis Investigative Site

    Monterrey Nuevo Leon, Monterrey 64710
    Mexico

    Site Not Available

  • Novartis Investigative Site

    San Pedro Garza Garcia, 66278
    Mexico

    Site Not Available

  • Novartis Investigative Site

    Trujillo, La Libertad 13011
    Peru

    Active - Recruiting

  • Novartis Investigative Site

    San Borja, Lima 41
    Peru

    Active - Recruiting

  • Novartis Investigative Site

    Gdansk, 80 952
    Poland

    Site Not Available

  • Novartis Investigative Site

    Lisboa, 1400-038
    Portugal

    Site Not Available

  • Novartis Investigative Site

    Loures, 2674514
    Portugal

    Site Not Available

  • Novartis Investigative Site

    Porto, 4200-072
    Portugal

    Site Not Available

  • Novartis Investigative Site

    Singapore, 119228
    Singapore

    Site Not Available

  • Novartis Investigative Site

    Cape Town, 7500
    South Africa

    Site Not Available

  • Novartis Investigative Site

    Johannesburg, 2196
    South Africa

    Site Not Available

  • Novartis Investigative Site

    Pretoria, 0002
    South Africa

    Site Not Available

  • Novartis Investigative Site

    Sant Joan Despi, Barcelona 08970
    Spain

    Site Not Available

  • Novartis Investigative Site

    Taipei, 10002
    Taiwan

    Site Not Available

  • Novartis Investigative Site

    Diyarbakir, 21000
    Turkey

    Site Not Available

  • Novartis Investigative Site

    Izmir, 35100
    Turkey

    Site Not Available

  • Novartis Investigative Site

    Kecioren Ankara, 06010
    Turkey

    Site Not Available

  • Novartis Investigative Site

    Malatya, 44280
    Turkey

    Site Not Available

  • Ironwood Cancer and Research Centers

    Chandler, Arizona 85224
    United States

    Active - Recruiting

  • Highlands Oncology Group

    Fayetteville, Arkansas 72703
    United States

    Active - Recruiting

  • Beverly Hills Cancer Center

    Beverly Hills, California 90211
    United States

    Active - Recruiting

  • Poudre Valley Hospital

    Fort Collins, Colorado 80528
    United States

    Site Not Available

  • Mid Florida Hematology And Onc Ctr

    Orange, Florida 32763
    United States

    Site Not Available

  • Mid Florida Hematology and Onc Ctr

    Orange City, Florida 32763
    United States

    Site Not Available

  • Mid Florida Hematology and Oncology Center

    Orange City, Florida 32763
    United States

    Site Not Available

  • Summit Cancer Care

    Savannah, Georgia 31405
    United States

    Site Not Available

  • John D Archbold Memorial Hospital

    Thomasville, Georgia 31792
    United States

    Site Not Available

  • Joliet Oncology-Hematology Associates

    Joliet, Illinois 60435
    United States

    Site Not Available

  • Duly Health and Care

    Plainfield, Illinois 60585
    United States

    Active - Recruiting

  • Indian Univ Health Goshen Center forCancer

    Goshen, Indiana 46526
    United States

    Active - Recruiting

  • Indiana University Health Goshen Center for Cancer

    Goshen, Indiana 46526
    United States

    Active - Recruiting

  • Northern Light Mercy Hospital

    Portland, Maine 04102
    United States

    Active - Recruiting

  • Englewood Health

    Englewood, New Jersey 07631
    United States

    Active - Recruiting

  • The Valley Hospital / Luckow Pavillion

    Paramus, New Jersey 07652
    United States

    Active - Recruiting

  • The Valley Hospital Luckow Pavillion

    Paramus, New Jersey 07652
    United States

    Active - Recruiting

  • The Valley Hospital-Luckow Pavillion

    Paramus, New Jersey 07652
    United States

    Active - Recruiting

  • Eastchester Center for Cancer Care

    Bronx, New York 10469
    United States

    Completed

  • University Hospitals of Cleveland Seidman Cancer Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Oklahoma Cancer Specialists and Research Institute

    Tulsa, Oklahoma 74136
    United States

    Active - Recruiting

  • Millennium Research Clin Develop

    Houston, Texas 77090
    United States

    Site Not Available

  • Novartis Investigative Site

    Hanoi, 100000
    Vietnam

    Site Not Available

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