Trial of Palbociclib in Second Line of Advanced Sarcomas With CDK4 Overexpression.
Status:
Recruiting
Trial end date:
2020-12-31
Target enrollment:
Participant gender:
Summary
Non-randomized, open, single cohort, phase II, multicenter national clinical trial. 19 sites
in Spain.
Palbociclib will be administered orally at a dose of 125 mg once a day for 21 consecutive
days followed by 7 rest days to comprise a complete cycle of 28 days.
Treatment will continue until disease progression, development of unacceptable toxicity,
non-compliance, withdrawal of consent by the patient or investigator decision
The main goal is to determine progression-free survival rate (PFSR) according to RECIST 1.1
at 6 months