Trials / Completed
CompletedNCT02499146
Palbociclib Pharmacokinetics Study In Postmenopausal Chinese Women With ER (+), HER2 (-) Advanced Breast Cancer
A PHASE 1 OPEN-LABEL PHARMACOKINETICS STUDY OF PALBOCICLIB, A CYCLIN-DEPENDENT KINASE 4 AND 6 (CDK4/6) INHIBITOR, IN POSTMENOPAUSAL CHINESE WOMEN WITH ER (+), HER2 (-) ADVANCED BREAST CANCER
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- Female
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
As part of the global clinical development program for Palbociclib, studies are planned in cancer patients in China. An assessment of Palbociclib pharmacokinetics in Chinese patients, as required by the Chinese Health Authorities, is therefore warranted. In addition, safety and efficacy will be also evaluated. The single and multiple 125 mg oral dose pharmacokinetics of Palbociclib will be characterized.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Palbociclib | 125 mg orally once daily with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle |
| DRUG | Letrozole | 2.5 mg , orally once daily (continuously) |
Timeline
- Start date
- 2015-09-11
- Primary completion
- 2018-07-31
- Completion
- 2024-12-24
- First posted
- 2015-07-15
- Last updated
- 2026-02-11
- Results posted
- 2019-07-29
Locations
7 sites across 1 country: China
Source: ClinicalTrials.gov record NCT02499146. Inclusion in this directory is not an endorsement.