Last updated on February 2018

Phase II Multicenter Trial of Palbociclib in Second Line of Advanced Sarcomas With CDK4 Overexpression.


Brief description of study

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

Clinical Study Identifier: NCT03242382

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