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Phase I/II study to evaluate treatment of patients with melanoma using Pfizerâ€™s palbociclib and GSKâ€™s trametinib.
Pfizer announced that it has entered into an agreement with GlaxoSmithKline (GSK) to assess safety and efficacy of Pfizer’s palbociclib plusGSK’s trametinib combination therapy in patients with advanced/metastatic melanoma.
The Phase I/II trial is a dose-escalation, open-label study, designed to determine the recommended combination regimen (RCR) for palbociclib plus trametinib in patients with melanoma. The study will also evaluate the effect of the combination therapy on tumor biomarkers, safety and anti-cancer activity in patients with BRAFV600 wild type melanoma, including those with NRAS mutations.
Both Pfizer and GSK will collaborate on the study, which will be conducted by GSK. Financial terms of the agreement were not disclosed.
Palbociclib is an investigational oral selective inhibitor of cyclin dependent kinases (CDK) 4 and 6 developed by Pfizer. The agent received breakthrough designation by the FDA in April 2013 for the potential treatment of patients with breast cancers. Palbociclib is not approved for any indication in any markets.
Trametinib, a reversible inhibitor of MEK1 and MEK2 developed by GSK, is approved by the FDA under the trade name Mekinist for the treatment of adult patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutation as detected by an FDA-approved test. Mekinist is not indicated for the treatment of patients who have received a prior BRAF inhibitor therapy.