NCT05732428CompletedPhase 1
A PHASE 1, OPEN LABEL STUDY EVALUATING THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF ARV-471 (PF-07850327) AS A SINGLE AGENT IN CHINESE PARTICIPANTS WITH ER+/HER2- ADVANCED BREAST CANCER
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 9
- Locations
- 3
- Primary Endpoint
- Multiple dose Cmax
Study Overview
Brief Summary
The purpose of this clinical trial is to learn about the pharmacokinetics. safety and tolerability of the study medicine (called ARV-471) for the potential treatment of advanced estrogen receptor postive and human epidermal growth factor receptor 2 negative breast cancer.
This study is seeking participants have
- ER+/HER2- advanced breast cancer
- received at least 1 line of endocrine therapy with or without CDK4/6 inhibitor
- received up to 2 prior regimens of chemotherapy for advanced setting. All participants in this study will receive ARV-471. ARV-471 will be given by mouth at home once a day. The experiences of people receiving the study medicine will be examined. This will help determine if the study medicine is safe and effective.
Participants will take part in this study until their cancer is no longer responding. During this time, they will have visits at the study clinic about every 4 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histological or cytological diagnosis of breast cancer with evidence of ER+/HER2- locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent.
- •Received at least 1 line of SOC of endocrine therapy with or without CDK4/6 inhibitor for locally advanced or metastatic disease.
- •Up to 2 prior regimens of chemotherapy for advanced or metastatic disease setting are allowed.
Exclusion Criteria
- •Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Participants with a history of CNS metastases or cord compression are eligible if they have been definitively treated (eg, radiotherapy, stereotactic surgery) and clinically stable (including patients with residual CNS symptoms/deficits) off enzyme-inducing anticonvulsants and steroids for at least 28 days prior to first dose of study drug.
- •Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association Class III or IV), cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism or other clinically significant episode of thromboembolic disease, congenital long QT syndrome, Torsade de Pointes, serious conduction system abnormalities (eg, bifascicular block defined as right bundle branch and left anterior or posterior hemiblock, 3rd degree AV block), clinically important arrhythmias, left anterior hemiblock (bifascicular block), ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥2, atrial fibrillation of any grade.
Arms & Interventions
ARV-471
Experimental
Intervention: ARV-471 (Drug)
Outcomes
Primary Outcomes
Multiple dose Cmax
Time Frame: 0, 1, 2, 4, 6, 8, 12, 24 hours post-dose Up to Day 71
Maximum Observed Plasma Concentration (Cmax)
Single dose Cmax (Maximum plasma concentration)
Time Frame: 0, 1, 2, 4, 6, 8, 12, 24 hours post-dose up to Day 2
Maximum plasma concentration
Single dose AUCtau
Time Frame: 0, 1, 2, 4, 6, 8, 12, 24 hours post-dose Up to Day 2
Area under the concentration-time profile from time zero to time tau (τ), the dosing interval, where tau = 24 hours (QD dosing)
Multiple dose AUCtau
Time Frame: 0, 1, 2, 4, 6, 8, 12, 24 hours post-dose Up to Day 71
Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 24 hours.
Secondary Outcomes
- Multiple dose Ctrough(0, 1, 2, 4, 6, 8, 12, 24 hours post-dose Up to Day 71)
- Single dose Vz/F(0, 1, 2, 4, 6, 8, 12, 24 hours post-dose Up to Day 2)
- Percentage of Participants With Clinical Benefit(Baseline up to 24 weeks)
- Presence (rate) or absence of blood biomarkers(immediately after the end of treatment)
- Number of Participants With Notable Electrocardiogram (ECG) Values(From baseline up to 28 days after last dose of study drug)
- Number of Participants With Adverse Events (AEs) by type, frequency, severity (as graded by NCI CTCAE verision 5.0), timing, seriousness and relationship to study treatment(Baseline up to 28 days after the last dose of study drug)
- Objective Response Rate - Percentage of Participants With Objective Response(Baseline up to 24 weeks)
- Single dose AUClast(0, 1, 2, 4, 6, 8, 12, 24 hours post-dose Up to Day 2)
- Number of Participants With Laboratory Abnormalities(Baseline (Day 1) up to at least 28 days after last dose of study drug)
- Number of Participants With Clinically Significant Change From Baseline in Vital Signs(Baseline up to 28 days after last dose of study drug)
- Single dose t½(0, 1, 2, 4, 6, 8, 12, 24 hours post-dose Up to Day 2)
- Multiple dose Tmax(0, 1, 2, 4, 6, 8, 12, 24 hours post-dose Up to Day 71)
- t½eff(0, 1, 2, 4, 6, 8, 12, 24 hours post-dose Up to Day 71)
- Multiple dose t½(0, 1, 2, 4, 6, 8, 12, 24 hours post-dose Up to Day 71)
- Single dose MRAUCtau(0, 1, 2, 4, 6, 8, 12, 24 hours post-dose Up to Day 2)
- Duration of Objective Response (DOR)(From the date of first documented response (CR or PR) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 weeks)
- Single dose Tmax(0, 1, 2, 4, 6, 8, 12, 24 hours post-dose Up to Day 2)
- Single dose CL/F(0, 1, 2, 4, 6, 8, 12, 24 hours post-dose Up to Day 2)
- Single dose MRCmax(0, 1, 2, 4, 6, 8, 12, 24 hours post-dose Up to Day 2)
- Single dose AUCinf(0, 1, 2, 4, 6, 8, 12, 24 hours post-dose Up to Day 2)
- Rac(0, 1, 2, 4, 6, 8, 12, 24 hours post-dose Up to Day 71)
- Multiple dose Vz/F(0, 1, 2, 4, 6, 8, 12, 24 hours post-dose Up to Day 71)
- Multiple dose MRCmax(0, 1, 2, 4, 6, 8, 12, 24 hours post-dose Up to Day 71)
- Multiple dose CL/F(0, 1, 2, 4, 6, 8, 12, 24 hours post-dose Up to Day 71)
- Multiple dose AUClast(0, 1, 2, 4, 6, 8, 12, 24 hours post-dose Up to Day 71)
- Multiple dose Cmin(0, 1, 2, 4, 6, 8, 12, 24 hours post-dose Up to Day 71)
Investigators
Study Sites (3)
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