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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 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 31 participants.
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.
Interventions
- DRUG palbociclib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2014-05 |
| Est. Completion | 2016-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02085538
The ClinicalTrials.gov registry entry for NCT02085538 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which palbociclib is the first listed.
NCT02085538 reports 0 study locations.
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.
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