Study Of Palbociclib (PD-0332991) In Renal Impairment
A Phase 1, Open-label, Single Dose, Parallel-group Study To Evaluate The Pharmacokinetics Of Palbociclib (Pd-0332991) In Subjects With Impaired Renal Function
1 other identifier
interventional
31
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2014
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2014
CompletedFirst Posted
Study publicly available on registry
March 13, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedApril 30, 2018
April 1, 2018
2 years
March 11, 2014
April 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
8 days
Maximum Observed Plasma Concentration (Cmax)
8 days
Secondary Outcomes (11)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
8 days
Apparent Oral Clearance (CL/F)
8 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
8 days
Apparent Volume of Distribution (Vz/F)
8 days
Plasma Decay Half-Life (t1/2)
8 days
- +6 more secondary outcomes
Study Arms (4)
Normal Renal Function
EXPERIMENTALMild Renal Impairment
EXPERIMENTALModerate Renal Impairment
EXPERIMENTALSevere Renal Impairment
EXPERIMENTALInterventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (3)
Avail Clinical Research, LLC
DeLand, Florida, 32720, United States
Orlando Clinical Research Center
Orlando, Florida, 32809, United States
Prism Research
Saint Paul, Minnesota, 55114, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2014
First Posted
March 13, 2014
Study Start
May 1, 2014
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
April 30, 2018
Record last verified: 2018-04