Study Of Palbociclib (PD-0332991) In Renal Impairment

Pfizer

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: palbociclib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02085538

A5481014

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 4 patient groups

Normal Renal Function

Experimental group

Treatment:

Drug: palbociclib

Drug: palbociclib

Drug: palbociclib

Drug: palbociclib

Mild Renal Impairment

Experimental group

Treatment:

Drug: palbociclib

Drug: palbociclib

Drug: palbociclib

Drug: palbociclib

Moderate Renal Impairment

Experimental group

Treatment:

Drug: palbociclib

Drug: palbociclib

Drug: palbociclib

Drug: palbociclib

Severe Renal Impairment

Experimental group

Treatment:

Drug: palbociclib

Drug: palbociclib

Drug: palbociclib

Drug: palbociclib