🏛️ Verified NIH Record • Updated 2026-06-22

Roll-over Study to Allow Continued Access to Ribociclib (NCT05161195)

A Post-trial Access Roll-over Study to Allow Access to Ribociclib (LEE011) for Patients Who Are on Ribociclib Treatment in Novartis-sponsored Study

🔵 Active, Not Recruiting Phase4 💊 Investigational Drug / Biologic Sponsor: Novartis Pharmaceuticals

🩺 Plain-English Summary (8th-Grade Level)

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).

Who can join: Review the eligibility criteria below.

Location: Ironwood Cancer and Research Centers — Chandler, Arizona

Age range: 18 Years to 100 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (73 Sites)

Showing the first 25 of 73 sites.

  • Ironwood Cancer and Research Centers — Chandler, Arizona
  • Highlands Oncology Group — Fayetteville, Arkansas
  • Beverly Hills Cancer Center — Beverly Hills, California
  • Poudre Valley Hospital — Fort Collins, Colorado
  • Mid Florida Hematology And Onc Ctr — Orange, Florida
  • Summit Cancer Care — Savannah, Georgia
  • John D Archbold Memorial Hospital — Thomasville, Georgia
  • Duly Health and Care — Plainfield, Illinois
  • Indian Univ Health Goshen Center forCancer — Goshen, Indiana
  • Northern Light Mercy Hospital — Portland, Maine
  • Englewood Health — Englewood, New Jersey
  • The Valley Hospital-Luckow Pavillion — Paramus, New Jersey
  • Eastchester Center for Cancer Care — The Bronx, New York
  • University Hospitals of Cleveland Seidman Cancer Center — Cleveland, Ohio
  • Oklahoma Cancer Specialists and Research Institute — Tulsa, Oklahoma
  • Millennium Research Clin Develop — Houston, Texas
  • Novartis Investigative Site — San Juan,
  • Novartis Investigative Site — Natal, Rio Grande do Norte
  • Novartis Investigative Site — Ijuí, Rio Grande do Sul
  • Novartis Investigative Site — Florianópolis, Santa Catarina
  • Novartis Investigative Site — São Paulo, São Paulo
  • Novartis Investigative Site — São Paulo, São Paulo
  • Novartis Investigative Site — Sao Jose Rio Preto,
  • Novartis Investigative Site — São Paulo,
  • Novartis Investigative Site — Chongqing, Chongqing Municipality

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗