Study Of Palbociclib (PD-0332991) In Renal Impairment

Completed · Phase 1

Conditions studied: Renal Impairment

In brief

Since the amount of palbociclib eliminated in urine is 6.9%, renal impairment is not expected to have much impact on palbociclib. However, the Federal Drug Administration (FDA) Guidance recommends a study in subjects with renal impairment when the drug is likely to be used in patients with impaired renal function. Palbociclib is intended for chronic use in cancer patients who may have some degree of impaired renal function.

Key facts

Study ID

NCT02085538

Run by

Pfizer

People needed

31

Starts

2014-05-01

Expected to finish

2016-05-01

Last updated by the study team

2018-04-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Personally signed and dated informed consent document.
• Renal function calculated by the Cockcroft Gault equation: normal function (CLcr >=90 mL/min), mild: CLcr >=60 mL/min and <90 mL/min, moderate: CLcr >=30 mL/min and <60 mL/min, severe: CLcr <30 mL/min but not requiring hemodialysis.
• Subjects with normal renal function matched for age, weight, gender and race to subjects in impaired renal function groups.

You may not qualify if…

• Any condition possibly affecting drug absorption.
• Renal allograft recipients.

Where it is running

• Avail Clinical Research, LLC — DeLand, Florida, United States
• Orlando Clinical Research Center — Orlando, Florida, United States
• Prism Research — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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