Trials / Active Not Recruiting
Active Not RecruitingNCT05463952
A Study to Learn About the Vepdegestrant (ARV-471, PF-07850327) in People With ER+/HER2- Locally Advanced or Metastatic Breast Cancer (BC)
A PHASE I, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF ARV-471 (PF-07850327), A SINGLE AGENT IN JAPANESE PARTICIPANTS WITH ER+/HER2-LOCALLY ADVANCED OR METASTATIC BREAST CANCER
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this clinical trial is to learn about the safety, tolerability, Pharmacokinetics (PK), and preliminary efficacy of ARV-471 as monotherapy in Japanese participants with ER+/HER2- locally advanced or metastatic breast cancer (mBC).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | vepdegestrant | ARV-471 will be administered orally QD with food, in continuous dosing over 28-day cycles. |
Timeline
- Start date
- 2022-08-16
- Primary completion
- 2023-05-04
- Completion
- 2025-03-31
- First posted
- 2022-07-19
- Last updated
- 2024-11-13
- Results posted
- 2024-09-23
Locations
3 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT05463952. Inclusion in this directory is not an endorsement.