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

Official Title

A Phase I/II Study of Safety and Efficacy of Ribociclib (LEE011) in Combination With Trametinib (TMT212) in Patients With Metastatic or Advanced Solid Tumours

Summary:

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

Trial Description

Primary Outcome:

  • Incidence of dose limiting toxicities (DLTs)
  • Objective Response Rate (ORR)
Secondary Outcome:
  • Duration of response (DOR)
  • Time to response
  • Disease control rate
  • Progression disease rate
  • Progression free survival
  • overall survival

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society