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Study Of Palbociclib (PD-0332991) In Renal Impairment

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Avail Clinical Research, LLC
DeLand, Florida, 32720 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Impairment
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 =30 mL/min and mL/min, severe: CLcr

- Subjects with normal renal function matched for age, weight, gender and race to
subjects in impaired renal function groups.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Any condition possibly affecting drug absorption.

- Renal allograft recipients.

NCT02085538
Pfizer
Completed
Study Of Palbociclib (PD-0332991) In Renal Impairment

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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
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Renal Impairment
Drug: palbociclib
palbociclib 125 mg oral capsule with food once
  • Experimental: Normal Renal Function
    Intervention: Drug: palbociclib
  • Experimental: Mild Renal Impairment
    Intervention: Drug: palbociclib
  • Experimental: Moderate Renal Impairment
    Intervention: Drug: palbociclib
  • Experimental: Severe Renal Impairment
    Intervention: Drug: palbociclib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
May 2016
May 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02085538
A5481014
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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