Study of Safety and Efficacy of Ribociclib and Trametinib in Patients With Metastatic or Advanced Solid Tumors

Stopped early · Phase 1

Conditions studied: Solid Tumors for Phase Ib, Pancreatic Cancer for Phase II, Colorectal Cancer for Phase II

In brief

Phase Ib dose escalation in advanced solid tumors to identify dose for Phase II dose expansion in advanced or metastatic pancreatic cancer and KRAS-mutant colorectal cancer. Open-label, nonrandomized.

Key facts

Study ID

NCT02703571

Run by

Novartis Pharmaceuticals

People needed

95

Starts

2016-06-29

Expected to finish

2019-09-24

Last updated by the study team

2020-12-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Phase II only:
• Patient has received prior treatment with a MEK inhibitor or a CDK4/6 inhibitor.
• Phase I and Phase II:
• Patient with a known hypersensitivity to the study drugs or any of the excipients of ribociclib or trametinib.
• Patient is concurrently using other anti-cancer therapy.
• Patient has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to Cycle 1 Day 1
• Patient has received local therapy to liver ≤ 3 months of C1D1
• History of liver disease as follow:
• Cirrhosis
• Autoimmune hepatitis
• Active viral hepatitis
• Portal hypertension
• Drug induced liver steatosis
• Prior systemic anti-cancer treatment within 28 days prior to Cycle 1 Day 1
• Prior therapy with anthracyclines at cumulative doses of 450 mg/ m2 or more for doxorubicin or 900 mg/m2 or more for epirubicin.
• Patient is currently receiving warfarin or other coumadin derived anti-coagulant
• Patient has a history of deep venin thrombosis or pulmonary embolism within 6 months of screening.
• Patient has a concurrent malignancy or malignancy within 3 years prior to Cycle 1 Day 1, with the exception of adequately treated basal or squamous cell carcinoma or curatively resected cervical cancer.
• Patients with central nervous system (CNS) involvement
• Patient has impairment of GI function or GI disease that may significantly alter the absorption of the study drugs
• History of interstitial lung disease or pneumonitis.
• Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality
• Patient is currently receiving any strong inducers or inhibitors of CYP3A4/5 and/or Substances that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5 and cannot be discontinued 7 days prior to Cycle 1 Day 1:
• Patient is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment.
• History of retinal vein occlusion (RVO)

Where it is running

• Highlands Oncology Group — Fayetteville, Arkansas, United States
• City of Hope National Medical Center — Duarte, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• University of Miami Sylvester Comp Cancer Ctr — Miami, Florida, United States
• Dana Farber Cancer Center — Boston, Massachusetts, United States
• UT MD Anderson Cancer Center — Houston, Texas, United States
• Novartis Investigative Site — Melbourne, Victoria, Australia
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Edmonton, Alberta, Canada
• Novartis Investigative Site — Vancouver, British Columbia, Canada
• Novartis Investigative Site — Cologne, Germany
• Novartis Investigative Site — Ulm, Germany
• Novartis Investigative Site — Amsterdam, Netherlands
• Novartis Investigative Site — Utrecht, Netherlands
• Novartis Investigative Site — Barcelona, Catalonia, Spain

Full record on ClinicalTrials.gov

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