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Trial · Interventional

TerminatedPhase 1/2Results postedRegistry data

A Study of PF-06873600 in People With Cancer

NCTNCT03519178 (opens ClinicalTrials.gov in a new tab)Other idC3661001Other idNCT03519178
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Goserelin, does not test it. It appears in the conditions.
  • Names Leuprolide, does not test it. It appears in the conditions.

Overview

Status
Terminated
Phase
Phase 1/2
Enrollment
155 participants (actual)
Sponsor
Pfizer · Industry
Design
Not randomized · Open label (no masking)
Countries
6 countries

United States, Bulgaria, Canada, Japan, Russia, Ukraine

Start
7 Mar 2018
Primary completion
5 Apr 2023
Completion
30 Oct 2024
First posted
8 May 2018
Last update posted
14 Nov 2025
Conditions
HR+ HER2- Metastatic Breast Cancer, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Triple Negative Breast Cancer, Male Breast Cancer

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2018202020222024
  1. Ph 1/2

    A Study of PF-06873600 in People With Cancer

    NCT03519178

    7 Mar 2018 to 30 Oct 2024

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this clinical trial is to learn about the safety and effects of study medicine (PF-06873600) when taken alone or with hormone therapy by people with cancer. People may be able to participate in this study if they have the following types of cancer: Hormone Receptor positive (HR+) breast cancer; Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer that is advanced or metastatic (spread to other parts of the body); triple negative breast cancer; epithelial ovarian cancer; fallopian tube cancer; or primary peritoneal cancer. All participants in this study will receive the study medicine by mouth, 1 to 2 times a day at home. The dose of the study medicine may be changed during the study. Some participants will also receive hormone therapy. The hormone therapy will be either letrozole by mouth once a day at home, or fulvestrant as a shot into the muscle. Fulvestrant will be given every two weeks at the study clinic for the first month, and then once a month after that. Participants will take part in this study for at least 7 to 8 months, depending on how they respond to the therapy. During this time participants will visit the study clinic once a week for the first 2 cycles and every cycle thereafter.

Interventions

  • PF-06873600Drug
  • Endocrine Therapy 1Drug
  • Endocrine Therapy 2Drug

Arms8

  • Experimental

    Dose Escalation

    Single Agent Dose Escalation

  • Experimental

    Dose Finding Endocrine Therapy 1 Combination

    Part 1B PF-06873600 plus Endocrine Therapy 1

  • Experimental

    Dose Finding Endocrine Therapy 2 Combination

    Part 1B PF-06873600 plus Endocrine Therapy 2

  • Experimental

    Dose Expansion Arm A

    PF-06873600 as a Single Agent

  • Experimental

    Dose Expansion Arm B

    PF-06873600 as a Single Agent in Various Tumor Types

  • Experimental

    Dose Expansion Arm C

    PF-06873600 in Combination with Endocrine Therapy 1

  • Experimental

    Dose Expansion Arm D

    PF-06873600 in Combination with Endocrine Therapy 1

  • Experimental

    Dose Expansion Arm E

    PF-06873600 in Combination with Endocrine Therapy 2

Primary outcomes7

Outcomes the sponsor listed as primary.

  1. Number of Participants With Dose Limiting Toxicities (DLTs) - Part 1

    Time frame · Cycle 1 (within 28 days after the first dose of study intervention)

    Registry description

    DLT was defined as any of the following adverse events (AEs) occurring in the first cycle of treatment (28 days) which were attributable to one, the other, or both agents in the combination: Hematologic - grade(G) 4 neutropenia lasting \>7 days; Febrile neutropenia defined as an absolute neutrophil count (ANC) \<1.0 \* 10\^9/L with a single temperature of \>38.3°C, or a sustained temperature of ≥38°C, for more than 1 hour; G≥3 neutropenia with associated infection; G3 thrombocytopenia with clinically significant bleeding as indicated by ≥ G2 bleeding; G4 thrombocytopenia. Nonhematologic: Confirmed case of Drug Induced Liver Injury (DILI) (Hy's Law); G≥3 AEs that were clinically significant.

  2. Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) - Part 1 + Part 2

    Time frame · Day 1 up to 28 days after the last dose of study intervention, up to approximately 24 months

    Registry description

    An AE was defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occurred after participants' signed informed consent has been obtained. An SAE was an AE resulting in any of the following outcomes: was fatal or life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; was medically significant; required inpatient hospitalization or prolongation of existing hospitalization. Treatment Related AEs were treatment emergent AEs with cause categorized by the investigator as related to study treatment.

  3. Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2

    Time frame · Day 1 up to 28 days after the last dose of study intervention, up to approximately 24 months

    Registry description

    Severity was graded as NCI CTCAE version 4.03:Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.

  4. Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2

    Time frame · Day 1 up to 28 days after the last dose of study intervention, up to approximately 24 months

    Registry description

    Severity was graded as NCI CTCAE version 4.03:Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.

  5. Number of Participants With Post-Baseline Vital Sign Abnormalities Meeting Pre-Defined Categorization - Part 1 + Part 2

    Time frame · Day 1 up to 28 days after the last dose of study intervention, up to approximately 24 months

    Registry description

    Pre-defined criteria included: 1) systolic blood pressure (SBP) (mm Hg) minimum (min) value \<90; 2) SBP change from baseline (CFB) (mm Hg) maximum (max) decrease \>=30 or max increase \>=30; 3) diastolic blood pressure (DBP) (mm Hg) min \<50; 4) DBP CFB (mm Hg) max decrease \>=20 or max increase \>=20; 5) supine heart rate (HR) beats per minute (bpm) min \<40 or max \>120.

  6. Number of Participants With Post-Baseline Electrocardiogram (ECG) Changes Meeting Pre-Defined Categorization - Part 1 + Part 2

    Time frame · Day 1 up to 28 days after the last dose of study intervention, up to approximately 24 months

    Registry description

    ECG pre-defined categories for QTc interval adjusted according to Fridericia formula (QTcF) (msec) included: 450 \<= max. \<=480, 481 \<= max. \<=500, max \>=501; QTcF CFB: 30 \< max \<=60, max \>60; for PR and QRS: PR (msec): max \>=300; PR increase from baseline: Baseline \>200 and max. \>=25% increase, Baseline \<=200 and max. \>=50% increase; QRS (msec): max \>=200; QRS (msec) increase from baseline: Baseline \>100 and max. \>=25% increase, Baseline \<=100 and max. \>=50% increase. Categories, with at least 1 participant having ECG abnormality in any of the reporting arms, were reported in this outcome measure.

  7. Overall Response Rate (ORR): Part 2

    Time frame · From the start of the treatment until disease/clinical progression or death or early study discontinuation, whichever happened earlier (approximately up to 24 months)

    Registry description

    ORR: percentage of participants with confirmed complete response (CR) or partial response (PR). Response evaluation criteria in solid tumors (RECIST) v1.1: a) CR = disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions that had a reduction in short axis to less than (\<) 10 millimeter (mm). Disappearance of all non-target lesions. In addition, all lymph nodes assigned a non-target lesion must be non-pathological in size (\<10 mm short axis) and b) PR = at least a 30 percent (%) decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Any radiological assessments taken more than 30 days after the last dose of study therapy or after antineoplastic agents other than study treatments taken by the participants was excluded from the best overall response derivation. Confirmation of CR or PR was to be at least 4 weeks apart from the previous radiological assessment.

Secondary outcomes(17)

  1. Maximum Observed Plasma Concentration (Cmax) of PF-06873600 Following a Single Oral Dose of Study Intervention on Cycle 1 Day 1 - Part 1 + Part 2

    Time frame · Part 1: pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on Cycle 1 Day 1 (C1D1); Part 2: pre-dose, 1, 2, 4, 6 hours post-dose on C1D1

    Registry description

    The maximum observed concentration of PF-06873600 after single dose of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B and Part 2) was reported. The Cmax value was observed directly from data.

  2. Time to Reach Cmax at Steady State (Tmax) of PF-06873600 Following a Single Oral Dose of Study Intervention on Cycle 1 Day 1 - Part 1 + Part 2

    Time frame · Part 1: pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D1; Part 2: pre-dose, 1, 2, 4, 6 hours post-dose on C1D1

    Registry description

    Tmax of PF-06873600 after single dose of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B and Part 2) was reported.

  3. Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06873600 Following a Single Oral Dose of Study Intervention on Cycle 1 Day 1 - Part 1

    Time frame · Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D1

    Registry description

    AUClast of PF-06873600 after single dose of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B) was reported.

  4. Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06873600 Following a Single Oral Dose of Study Intervention on Cycle 1 Day 1 - Part 1

    Time frame · Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D1

    Registry description

    AUCinf of PF-06873600 after single dose of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B) was reported.

  5. Apparent Clearance (CL/F) of PF-06873600 Following a Single Oral Dose of Study Intervention on Cycle 1 Day 1 - Part 1

    Time frame · Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D1

    Registry description

    CL/F of PF-06873600 after single dose of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B) was reported.

  6. Apparent Volume of Distribution (Vz/F) of PF-06873600 Following a Single Oral Dose of Study Intervention on Cycle 1 Day 1 - Part 1

    Time frame · Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D1

    Registry description

    Vz/F of PF-06873600 after single dose of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B) was reported.

  7. Terminal Half-life (t1/2) of PF-06873600 Following a Single Oral Dose of Study Intervention on Cycle 1 Day 1 - Part 1

    Time frame · Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D1

    Registry description

    t1/2 of PF-06873600 after single dose of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B) was reported.

  8. Steady State Maximum Concentration (Css,Max) of PF-06873600 Following Multiple Doses of Study Intervention on Cycle 1 Day 15 - Part 1 + Part 2

    Time frame · Part 1: pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D15; Part 2: pre-dose, 1, 2, 4, 6 hours post-dose on C1D15

    Registry description

    Css,max of PF-06873600 after multiple doses of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B and Part 2) was reported. Multiple-dose PK parameters were not calculated for the modified release selection cohort in Part 1C (ie, the group "Part 1C PF-06873600 MR 20 IR 25 mg BID").

  9. Time to Maximum Plasma Concentration at Steady State (Tss,Max) of PF-06873600 Following Multiple Doses of Study Intervention on Cycle 1 Day 15 - Part 1 + Part 2

    Time frame · Part 1: pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D15; Part 2: pre-dose, 1, 2, 4, 6 hours post-dose on C1D15

    Registry description

    Tss,max of PF-06873600 after multiple doses of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B and Part 2) was reported. Multiple-dose PK parameters were not calculated for the modified release selection cohort in Part 1C (ie, the group "Part 1C PF-06873600 MR 20 IR 25 mg BID").

  10. Steady State Minimum Plasma Concentration (Css,Min) of PF-06873600 Following Multiple Doses of Study Intervention on Cycle 1 Day 15 - Part 1 + Part 2

    Time frame · Part 1: pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D15; Part 2: pre-dose, 1, 2, 4, 6 hours post-dose on C1D15

    Registry description

    Css,min of PF-06873600 after multiple doses of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B and Part 2) was reported. Multiple-dose PK parameters were not calculated for the modified release selection cohort in Part 1C (ie, the group "Part 1C PF-06873600 MR 20 IR 25 mg BID").

  11. Steady-State Area Under the Plasma Concentration Versus Time Curve Within One Dose Interval (AUCss,Tau) of PF-06873600 Following Multiple Doses of Study Intervention on Cycle 1 Day 15 - Part 1

    Time frame · Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D15

    Registry description

    AUCss,tau of PF-06873600 after multiple doses of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B) was reported. Multiple-dose PK parameters were not calculated for the modified release selection cohort in Part 1C (ie, the group "Part 1C PF-06873600 MR 20 IR 25 mg BID").

  12. Steady-State Apparent Oral Plasma Clearance (CLss/F) of PF-06873600 Following Multiple Doses of Study Intervention on Cycle 1 Day 15 - Part 1

    Time frame · Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D15

    Registry description

    CLss/F of PF-06873600 after multiple doses of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B) was reported. Multiple-dose PK parameters were not calculated for the modified release selection cohort in Part 1C (ie, the group "Part 1C PF-06873600 MR 20 IR 25 mg BID").

  13. Apparent Volume of Distribution at Steady State (Vss/F) of PF-06873600 Following Multiple Doses of Study Intervention on Cycle 1 Day 15 - Part 1

    Time frame · Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D15

    Registry description

    Vss/F of PF-06873600 after multiple doses of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B) was reported. Multiple-dose PK parameters were not calculated for the modified release selection cohort in Part 1C (ie, the group "Part 1C PF-06873600 MR 20 IR 25 mg BID").

  14. Accumulation Ratio Based on AUC (Rac) of PF-06873600 Following Multiple Doses of Study Intervention on Cycle 1 Day 15 - Part 1

    Time frame · Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D15

    Registry description

    Rac of PF-06873600 after multiple doses of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B) was reported. Multiple-dose PK parameters were not calculated for the modified release selection cohort in Part 1C (ie, the group "Part 1C PF-06873600 MR 20 IR 25 mg BID").

  15. Accumulation Ratio Based on Cmax (Observed) (Rac,Cmax) of PF-06873600 Following Multiple Doses of Study Intervention on Cycle 1 Day 15 - Part 2

    Time frame · Pre-dose, 1, 2, 4, 6 hours post-dose on C1D15

    Registry description

    Rac,cmax of PF-06873600 after multiple doses of study intervention when given as in combination with fulvestrant (Part 2) was reported.

  16. Pharmacodynamic (PD) Biomarker Phospho-retinoblastoma Protein (pRb) in Tumor Tissue in Participants - Part 1 + Part 2

    Time frame · Screening and Cycle 2 Day 1

    Registry description

    Level of the PD marker, pRb, was analyzed at 2 time points, at screening and at Cycle 2 Day 1. Percentage changes of pRb at Cycle 2 Day 1 from screening (baseline) were calculated.

  17. PD Biomarker Ki67 in Tumor Tissue in Participants - Part 1 + Part 2

    Time frame · Screening and Cycle 2 Day 1

    Registry description

    Level of the PD marker, Ki67, was analyzed at 2 time points, at screening and at Cycle 2 Day 1. Percent changes of pRb at Cycle 2 Day 1 from screening (baseline) were calculated.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· Cycle 1 (within 28 days after the first dose of study intervention)

Number of Participants With Dose Limiting Toxicities (DLTs) - Part 1

GroupValue (Participants)
Part 1A PF-06873600 1 mg Twice a Day (BID)0
Part 1A PF-06873600 2 mg BID0
Part 1A PF-06873600 5 mg BID0
Part 1A PF-06873600 10 mg BID0
Part 1A PF-06873600 25 mg BID0
Part 1A PF-06873600 25 mg BID Biomarker0
Part 1A PF-06873600 35 mg BID2
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off0
Part 1A PF-06873600 50 mg BID4
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination0
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination0
Part 1C PF-06873600 MR 20 IR 25 mg BID0
Part 1C PF-06873600 MR 30 mg BID Long Release0
Primary outcomeCount of participants· Day 1 up to 28 days after the last dose of study intervention, up to approximately 24 months

Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) - Part 1 + Part 2

GroupValue (Participants)
Part 1A PF-06873600 1 mg Twice a Day (BID)1
Part 1A PF-06873600 2 mg BID2
Part 1A PF-06873600 5 mg BID2
Part 1A PF-06873600 10 mg BID3
Part 1A PF-06873600 25 mg BID9
Part 1A PF-06873600 25 mg BID Biomarker6
Part 1A PF-06873600 35 mg BID4
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off13
Part 1A PF-06873600 50 mg BID10
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination9
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination7
Part 1C PF-06873600 MR 20 IR 25 mg BID5
Part 1C PF-06873600 MR 30 mg BID Long Release6
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination45
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination25
Primary outcomeCount of participants· Day 1 up to 28 days after the last dose of study intervention, up to approximately 24 months

Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2

GroupValue (Participants)
Part 1A PF-06873600 1 mg Twice a Day (BID)1
Part 1A PF-06873600 2 mg BID2
Part 1A PF-06873600 5 mg BID2
Part 1A PF-06873600 10 mg BID2
Part 1A PF-06873600 25 mg BID7
Part 1A PF-06873600 25 mg BID Biomarker7
Part 1A PF-06873600 35 mg BID3
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off5
Part 1A PF-06873600 50 mg BID6
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination7
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination5
Part 1C PF-06873600 MR 20 IR 25 mg BID4
Part 1C PF-06873600 MR 30 mg BID Long Release6
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination33
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination13
Primary outcomeCount of participants· Day 1 up to 28 days after the last dose of study intervention, up to approximately 24 months

Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2

GroupValue (Participants)
Part 1A PF-06873600 1 mg Twice a Day (BID)0
Part 1A PF-06873600 2 mg BID1
Part 1A PF-06873600 5 mg BID2
Part 1A PF-06873600 10 mg BID3
Part 1A PF-06873600 25 mg BID6
Part 1A PF-06873600 25 mg BID Biomarker5
Part 1A PF-06873600 35 mg BID3
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off9
Part 1A PF-06873600 50 mg BID8
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination8
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination5
Part 1C PF-06873600 MR 20 IR 25 mg BID2
Part 1C PF-06873600 MR 30 mg BID Long Release4
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination41
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination20
Primary outcomeCount of participants· Day 1 up to 28 days after the last dose of study intervention, up to approximately 24 months

Number of Participants With Post-Baseline Vital Sign Abnormalities Meeting Pre-Defined Categorization - Part 1 + Part 2

GroupValue (Participants)
Part 1A PF-06873600 1 mg Twice a Day (BID)0
Part 1A PF-06873600 2 mg BID0
Part 1A PF-06873600 5 mg BID0
Part 1A PF-06873600 10 mg BID0
Part 1A PF-06873600 25 mg BID2
Part 1A PF-06873600 25 mg BID Biomarker1
Part 1A PF-06873600 35 mg BID1
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off0
Part 1A PF-06873600 50 mg BID1
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination1
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination0
Part 1C PF-06873600 MR 20 IR 25 mg BID0
Part 1C PF-06873600 MR 30 mg BID Long Release0
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination3
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination0
Primary outcomeCount of participants· Day 1 up to 28 days after the last dose of study intervention, up to approximately 24 months

Number of Participants With Post-Baseline Electrocardiogram (ECG) Changes Meeting Pre-Defined Categorization - Part 1 + Part 2

GroupValue (Participants)
Part 1A PF-06873600 1 mg Twice a Day (BID)0
Part 1A PF-06873600 2 mg BID0
Part 1A PF-06873600 5 mg BID0
Part 1A PF-06873600 10 mg BID0
Part 1A PF-06873600 25 mg BID0
Part 1A PF-06873600 25 mg BID Biomarker0
Part 1A PF-06873600 35 mg BID0
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off0
Part 1A PF-06873600 50 mg BID0
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination0
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination0
Part 1C PF-06873600 MR 20 IR 25 mg BID0
Part 1C PF-06873600 MR 30 mg BID Long Release0
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination1
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination0
Primary outcomeNumber· From the start of the treatment until disease/clinical progression or death or early study discontinuation, whichever happened earlier (approximately up to 24 months)

Overall Response Rate (ORR): Part 2

GroupValue (Percentage of participants)
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination6.7
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination22.7
Secondary and other outcome results(1)
Secondary outcomeGeometric mean· Part 1: pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on Cycle 1 Day 1 (C1D1); Part 2: pre-dose, 1, 2, 4, 6 hours post-dose on C1D1

Maximum Observed Plasma Concentration (Cmax) of PF-06873600 Following a Single Oral Dose of Study Intervention on Cycle 1 Day 1 - Part 1 + Part 2

GroupValue (Nanogram per milliliter)Spread
Part 1A PF-06873600 1 mg Twice a Day (BID)5.39NA
Part 1A PF-06873600 2 mg BID22.131.9
Part 1A PF-06873600 5 mg BID29.190.8
Part 1A PF-06873600 10 mg BID164.137
Part 1A PF-06873600 25 mg BID243.547
Part 1A PF-06873600 25 mg BID Biomarker202.647
Part 1A PF-06873600 35 mg BID388.19
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off276.442
Part 1A PF-06873600 50 mg BID393.842
Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination225.428
Part 1B PF-06873600 25 mg BID IR/Letrozole Combination228.532
Part 1C PF-06873600 MR 20 IR 25 mg BID121.854
Part 1C PF-06873600 MR 30 mg BID Long Release43.51121
Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination224.943
Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination181.441

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Part 1A PF-06873600 1 mg BIDParticipants in Part 1A received PF-06873600 1 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.0 / 10 / 11 / 1
Part 1A PF-06873600 2 mg BIDParticipants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.0 / 21 / 22 / 2
Part 1A PF-06873600 5 mg BIDParticipants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.0 / 20 / 22 / 2
Part 1A PF-06873600 10 mg BIDParticipants in Part 1A received PF-06873600 10 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.0 / 30 / 33 / 3
Part 1A PF-06873600 25 mg BIDParticipants in Part 1A received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.1 / 92 / 99 / 9
Part 1A PF-06873600 25 mg BID BiomarkerParticipants in Part 1A, with pre and on-treatment tumor and skin biopsies collected, received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.0 / 70 / 76 / 7
Part 1A PF-06873600 35 mg BIDParticipants in Part 1A received PF-06873600 35 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.0 / 41 / 44 / 4
Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days OffParticipants in Part 1A received PF-06873600 35 mg orally intermittent dosing 5 days on/2 days off on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.1 / 134 / 1313 / 13
Part 1A PF-06873600 50 mg BIDParticipants in Part 1A received PF-06873600 50 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.3 / 106 / 1010 / 10
Part 1B PF-06873600 25 mg BID IR/Fulvestrant CombinationParticipants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or the study was terminated.1 / 91 / 99 / 9
Part 1B PF-06873600 25 mg BID IR/Letrozole CombinationParticipants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus letrozole 2.5 mg once daily as continuous daily dosing, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.0 / 72 / 77 / 7
Part 1C PF-06873600 MR 20 mg IR 25 mg BIDParticipants in Part 1C received a single dose of PF-06873600 MR 20 mg orally during the lead-in period on Day -7 and Day -4, followed by IR 25 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.0 / 50 / 55 / 5
Part 1C PF-06873600 MR 30 mg BID Long ReleaseParticipants in Part 1C received PF-06873600 MR 30 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.3 / 63 / 66 / 6
Part 2A PF-06873600 25 mg BID IR/Fulvestrant CombinationParticipants in Part 2A had received CDK4/6i treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.6 / 459 / 4545 / 45
Part 2C PF-06873600 25 mg BID IR/Fulvestrant CombinationParticipants in Part 2C who were naïve to CDK4/6i received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.4 / 285 / 2825 / 28

Each cell reads participants affected / participants at risk, as the registry posted them.

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Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Have a diagnosis of Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer • Prior combined CDK 4/6 inhibitor and endocrine therapy and 1 or 2 prior lines of chemotherapy * Have a diagnosis of metastatic triple negative breast cancer (TNBC) • Up to 1-2 prior lines of chemotherapy * Have a diagnosis of advanced platinum resistant epithelial ovarian cancer (EOC)/fallopian tube cancer/primary peritoneal cancer (PPC) • Up to 2-3 prior lines of therapy * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1 * Measurable disease or non-measurable disease and refractory to or intolerant of existing therapies (Part 1) * Measurable disease as defined by RECIST 1.1 is required (Part 1B and Part 2 only) Exclusion Criteria: * Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases * Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ * Major surgery or radiation within 4 weeks prior to study entry * Last anti-cancer treatment within 2 weeks prior to study entry * Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry * Pregnant or breastfeeding female patients * Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery including impairment of gastro intestinal function or GI disease

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