A Study of PF-06873600 in People With Cancer

NCT03519178 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: C3661001NCT03519178
• Study Type: interventional
• Target: 155
• Locations: 6 countries
• Sites: 54

Brief Summary

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.

Conditions

HR+ HER2- Metastatic Breast Cancer, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Triple Negative Breast Cancer, Male Breast Cancer

Keywords

Hormone Receptor (HR) Positive Breast Cancer; Estrogen receptor (ER) positive; Progesterone receptor (PR) positive; Cyclin-dependent kinase (CDK); Human epidermal growth factor receptor 2 (HER2) negative; Advanced breast cancer; Metastatic breast cancer (MBC); Triple negative breast cancer (TNBC); Epithelial ovarian cancer (EOC); Fallopian tube cancer; Primary peritoneal cancer (PPC); CDK4/6 inhibitor; Endocrine Therapy (ET); Measurable disease; Luteinizing Hormone Releasing Hormone (LHRH) Agonist; Goserelin; Leuprolide acetate

Outcome Measures

Primary Outcomes (7)

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

  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.

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

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

  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.

  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

  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.

  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

  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.

  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

  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.

  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

  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.

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

• Overall Response Rate (ORR): Part 2

  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.

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

Secondary Outcomes (17)

• 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

  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

• 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

  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

• 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

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

• 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

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

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

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

Study Arms (8)

Dose Escalation

EXPERIMENTAL

Single Agent Dose Escalation

Drug: PF-06873600

Dose Finding Endocrine Therapy 1 Combination

EXPERIMENTAL

Part 1B PF-06873600 plus Endocrine Therapy 1

Drug: PF-06873600; Drug: Endocrine Therapy 1

Dose Finding Endocrine Therapy 2 Combination

EXPERIMENTAL

Part 1B PF-06873600 plus Endocrine Therapy 2

Drug: PF-06873600; Drug: Endocrine Therapy 2

Dose Expansion Arm A

EXPERIMENTAL

PF-06873600 as a Single Agent

Drug: PF-06873600

Dose Expansion Arm B

EXPERIMENTAL

PF-06873600 as a Single Agent in Various Tumor Types

Drug: PF-06873600

Dose Expansion Arm C

EXPERIMENTAL

PF-06873600 in Combination with Endocrine Therapy 1

Drug: PF-06873600; Drug: Endocrine Therapy 1

Dose Expansion Arm D

EXPERIMENTAL

PF-06873600 in Combination with Endocrine Therapy 1

Drug: PF-06873600; Drug: Endocrine Therapy 1

Dose Expansion Arm E

EXPERIMENTAL

PF-06873600 in Combination with Endocrine Therapy 2

Drug: PF-06873600; Drug: Endocrine Therapy 2

Interventions

PF-06873600 DRUG

PF-06873600 tablet for oral dosing

Dose Escalation; Dose Expansion Arm A; Dose Expansion Arm B; Dose Expansion Arm C; Dose Expansion Arm D; Dose Expansion Arm E; Dose Finding Endocrine Therapy 1 Combination; Dose Finding Endocrine Therapy 2 Combination

Endocrine Therapy 1 DRUG

Endocrine Therapy 1

Dose Expansion Arm C; Dose Expansion Arm D; Dose Finding Endocrine Therapy 1 Combination

Endocrine Therapy 2 DRUG

Endocrine Therapy 2

Dose Expansion Arm E; Dose Finding Endocrine Therapy 2 Combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (54)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University Of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

HonorHealth

Scottsdale, Arizona, 85258, United States

Location

Virginia G. Piper Cancer Center Pharmacy

Scottsdale, Arizona, 85258, United States

Location

Highlands Oncology Group

Fayetteville, Arkansas, 72703, United States

Location

Highlands Oncology Group

Rogers, Arkansas, 72758, United States

Location

Highlands Oncology Group

Springdale, Arkansas, 72762, United States

Location

Highlands Oncology

Springdale, Arkansas, 72762, United States

Location

The Oncology Institute of Hope and Innovation

Glendale, California, 91204, United States

Location

The Oncology Institute of Hope and Innovation

Long Beach, California, 90805, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94143, United States

Location

UCSF Investigational Drugs Pharmacy

San Francisco, California, 94158, United States

Location

The Oncology Institute of Hope and Innovation

Santa Ana, California, 92705, United States

Location

UCLA Hematology/Oncology - Parkside

Santa Monica, California, 90404, United States

Location

UCLA Hematology/Oncology - Santa Monica

Santa Monica, California, 90404, United States

Location

The Oncology Institute of Hope and Innovation

Whittier, California, 90602, United States

Location

University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

Aurora, Colorado, 80045, United States

Location

University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)

Aurora, Colorado, 80045, United States

Location

University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)

Aurora, Colorado, 80045, United States

Location

UCHealth Lone Tree Medical Center

Lone Tree, Colorado, 80124, United States

Location

Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Memorial Sloan Kettering Cancer Center

Long Island City, New York, 11101, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

Location

The Sarah Cannon Research Institute-Pharmacy

Nashville, Tennessee, 37203, United States

Location

The Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, 78229, United States

Location

Northwest Medical Specialties, PLLC

Federal Way, Washington, 98003, United States

Location

Northwest Medical Specialties, PLLC

Gig Harbor, Washington, 98332, United States

Location

Rainier Hematology-Oncology PC

Puyallup, Washington, 98373, United States

Location

Rainier Hematology-Oncology, PC

Puyallup, Washington, 98373, United States

Location

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Northwest Medical Specialties, PLLC

Tacoma, Washington, 98405, United States

Location

Multiprofile Hospital of Active Treatment - Dobrich AD

Dobrich, 9300, Bulgaria

Location

Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD

Haskovo, 6300, Bulgaria

Location

Complex Oncology Center -Plovdiv

Plovdiv, 4000, Bulgaria

Location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

Location

Kanagawa cancer center

Yokohama, Kanagawa, 2418515, Japan

Location

Private Medical Institution "Euromedservice"

Pushkin, Sankt-Peterburg, 196603, Russia

Location

BIH of Omsk Region "Clinical Oncological Dispensary"

Omsk, 644013, Russia

Location

BIH of Omsk Region "Clinical Oncological Dispensary"

Omsk, 644046, Russia

Location

LLC "Medicina Severnoy Stolitsy"

Saint Petersburg, 191025, Russia

Location

LLC "Severo-Zapadny Medical Center"

Saint Petersburg, 192007, Russia

Location

Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council, "Dnipro State Me

Dnipro, Dnipropetrovsk Oblast, 49102, Ukraine

Location

Kharkiv Regional Specialized Dispensary of Radiation Protection of the Population

Kharkiv, Kharkivs’ka Oblast’, 61166, Ukraine

Location

Communal nonprofit enterprise "Kyiv City Clinical Oncology Center" of Executive Body of Kyiv City

Kyiv, 03115, Ukraine

Location

Communal noncommercial enterprise of Lviv regional council "Lviv oncological regional therapeutical

Lviv, 79031, Ukraine

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Triple Negative Breast Neoplasms; Breast Neoplasms, Male; Breast Neoplasms; Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: May 8, 2018
• Study Start: March 7, 2018
• Primary Completion: April 5, 2023
• Study Completion: October 30, 2024
• Last Updated: November 14, 2025
• Results First Posted: July 31, 2024

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (39); BU (3); JP (2); RU (5); CA (1); UA (4)