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A Phase 1b, Open-Label, Dose-escalation and Expansion Study to Investigate the Safety, Pharmacokinetics and Antitumor Activities of a RAF Dimer Inhibitor BGB-283 in Combination with a MEK inhibitor PD-0325901 in Patients with Advanced or Refractory Solid Tumors.

Primary Objectives:
- To assess the safety and tolerability of the combination of lifirafenib and mirdametinib.

- To determine the MTD, if any, and recommended dose for expansion (RDFE) for the combination.

Secondary Objectives:
- To characterize the PK of mirdametinib, the active metabolite PD-0315209 and lifirafenib in the combination.

- To assess the preliminary antitumor activity of the combination of lifirafenib and mirdametinib.

Protocol Number: 052403
Phase: Phase I
Applicable Disease Sites: Any Site
Drugs Involved: Lifirafenib
Mirdametinib
Principal Investigator: Sanjay Goel
Scope: National
Therapies Involved: Chemotherapy multiple agents systemic
Participating Institutions:
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.