HR-positive HER2-negative metastatic/advanced BC
Conditions
Brief summary
Part 1: First cycle DLTs., Part 1: AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) timing, seriousness, and relationship to study intervention., Part 1: Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing., Part 1: Vital sign abnormalities., Part 1: Heart rate corrected QT interval (eg, QTcF)., Part 2: First cycle DLTs (for the safety run-in)., Part 2: AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study treatment., Part 2: Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0, and timing.
Detailed description
Part 1: PK parameters of PF-07220060 and PF-07104091: • Single dose (PF-07104091) - Cmax, Tmax, AUClast, and as data permit, AUCinf, CL/F, Vz/F, and t1/2. • Multiple Dose (PF-07220060 & PF-07104091; assuming steady state is achieved) - Css,max, Tss,max, AUCss,τ, Css,min, CLss/F, and as data permit, Vss/F, t1/2, and Rac (AUCss,τ/AUCsd,τ) for PF-07104091., Part 1: AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) timing, seriousness, and relationship to study intervention., Part 1: Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing., Part 1: • ORR, as assessed using RECIST version 1.1., Part 1: TTE endpoints: eg, DoR, PFS, and TTP., Part 2: ORR and CBR as assessed using RECIST version 1.1., Part 2: TTE endpoints: DoR, PFS, and TTP., Part 2: Concentrations of PF-07220060 and PF-07104091 at selected time points.
Interventions
DRUGFULVESTRANT
DRUGLETROZOLE
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: First cycle DLTs., Part 1: AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) timing, seriousness, and relationship to study intervention., Part 1: Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing., Part 1: Vital sign abnormalities., Part 1: Heart rate corrected QT interval (eg, QTcF)., Part 2: First cycle DLTs (for the safety run-in)., Part 2: AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study treatment., Part 2: Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0, and timing. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: PK parameters of PF-07220060 and PF-07104091: • Single dose (PF-07104091) - Cmax, Tmax, AUClast, and as data permit, AUCinf, CL/F, Vz/F, and t1/2. • Multiple Dose (PF-07220060 & PF-07104091; assuming steady state is achieved) - Css,max, Tss,max, AUCss,τ, Css,min, CLss/F, and as data permit, Vss/F, t1/2, and Rac (AUCss,τ/AUCsd,τ) for PF-07104091., Part 1: AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) timing, seriousness, and relationship to study intervention., Part 1: Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing., Part 1: • ORR, as assessed using RECIST version 1.1., Part 1: TTE endpoints: eg, DoR, PFS, and TTP., Part 2: ORR and CBR as assessed using RECIST version 1.1., Part 2: TTE endpoints: DoR, PFS, and TTP., Part 2: Concentrations of PF-07220060 and PF-07104091 at selected time points. | — |
Countries
Bulgaria, Czechia, Spain
Outcome results
None listed