drugset / Trial / NCT02085538
Study Of Palbociclib (PD-0332991) In Renal Impairment
Non-randomizedParallel-groupOpen-labelBasic science
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.
Timeline
- Start
- 2014-05
- Primary completion
- 2016-05
- Completion
- 2016-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Palbociclib | Small molecule | 125 mg | Oral |