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NCT02085538 · ClinicalTrials.gov registry record · Phase 1
Study Of Palbociclib (PD-0332991) In Renal Impairment
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT02085538: Completed Phase 1 study, sponsored by Pfizer.
NCT02085538 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02085538, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study 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.
Primary Outcome
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).
Interventions
- DRUG palbociclib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2014-05 |
| Est. Completion | 2016-05 |
| Phase | Phase 1 |
What the finished NCT02085538 record still lists
NCT02085538 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 1 intervention - of which palbociclib is the first listed.
NCT02085538 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02085538 about?
NCT02085538 is a clinical study titled "Study Of Palbociclib (PD-0332991) In Renal Impairment". 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 ...
What is the current status of trial NCT02085538?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2014-05. Estimated completion is 2016-05.
What interventions are being tested in trial NCT02085538?
The interventions under investigation include: palbociclib (DRUG).
Who is sponsoring clinical trial NCT02085538?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02085538's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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