24
Participants
Start Date
November 18, 2020
Primary Completion Date
December 14, 2023
Study Completion Date
December 14, 2023
Combination, Palbociclib + Binimetinib
"Patients will then start treatment with continuous oral binimetinib 45 mg/BID and palbociclib 100 mg daily, 21 days on / 7 days off, until disease progression. Study treatment will continue until disease progression.~If treatment tolerance is good, after a full cycle patients will be allowed to escalate palbociclib to 125 mg, according to the study investigators' decision. Alternatively, patients with non tolerable grade 2 events will resume at 30 mg/BID of binimetinib upon recovery, maintaining palbociclib at 100 mg 21-on/7-off. Depending on the side-effects, in case of clear relationship with palbociclib is established, palbociclib -instead of binimetinib - will be reduced to 75 mg daily."
Hospital Universitari Arnau de Vilanova de Lleida, Lleida
Hospìtal Universitario de la Princesa, Madrid
Hospital Ramon y Cajal, Madrid
Hospital Clínico San Carlos, Madrid
Hospital Universitario 12 de Octubre, Madrid
Hospital QuirónSalud Madrid, Madrid
Hospital Universitario de Fuenlabrada, Madrid
Hospital Clínico Universitario de Valencia, Valencia
Lead Sponsor
Collaborators (1)
Pfizer
INDUSTRY
Apices Soluciones S.L.
INDUSTRY
Pierre Fabre Ibérica, S.A.
INDUSTRY
Fundacion Oncosur
NETWORK