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A Study of PF-06873600 in People With Cancer

Primary Purpose

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

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-06873600
Endocrine Therapy 1
Endocrine Therapy 2
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HR+ HER2- Metastatic Breast Cancer, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Triple Negative Breast Cancer, Male Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • University Of Alabama at Birmingham
  • HonorHealth Research Institute
  • HonorHealth
  • Virginia G. Piper Cancer Center Pharmacy
  • Highlands Oncology Group
  • Highlands Oncology Group
  • Highlands Oncology Group
  • Highlands Oncology
  • The Oncology Institute of Hope and Innovation
  • The Oncology Institute of Hope and Innovation
  • UCSF Helen Diller Family Comprehensive Cancer Center
  • UCSF Investigational Drugs Pharmacy
  • The Oncology Institute of Hope and Innovation
  • UCLA Hematology/Oncology - Parkside
  • UCLA Hematology/Oncology - Santa Monica
  • The Oncology Institute of Hope and Innovation
  • University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
  • University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
  • University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
  • UCHealth Lone Tree Medical Center
  • Holy Cross Hospital
  • Massachusetts General Hospital
  • Brigham & Women's Hospital
  • Dana Farber Cancer Institute
  • Dana-Farber Cancer Institute
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Cancer Center
  • Tennessee Oncology, PLLC
  • The Sarah Cannon Research Institute-Pharmacy
  • The Sarah Cannon Research Institute
  • The University of Texas MD Anderson Cancer Center
  • South Texas Accelerated Research Therapeutics, LLC
  • Northwest Medical Specialties, PLLC
  • Northwest Medical Specialties, PLLC
  • Rainier Hematology-Oncology PC
  • Rainier Hematology-Oncology, PC
  • Fred Hutchinson Cancer Center
  • Seattle Cancer Care Alliance
  • University of Washington Medical Center
  • Northwest Medical Specialties, PLLC
  • Multiprofile Hospital of Active Treatment - Dobrich AD
  • Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD
  • Complex Oncology Center -Plovdiv
  • McGill University Health Centre
  • National Cancer Center Hospital East
  • Kanagawa cancer center
  • Private Medical Institution "Euromedservice"
  • BIH of Omsk Region "Clinical Oncological Dispensary"
  • BIH of Omsk Region "Clinical Oncological Dispensary"
  • LLC "Medicina Severnoy Stolitsy"
  • LLC "Severo-Zapadny Medical Center"
  • Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council, "Dnipro State Me
  • Kharkiv Regional Specialized Dispensary of Radiation Protection of the Population
  • Communal nonprofit enterprise "Kyiv City Clinical Oncology Center" of Executive Body of Kyiv City
  • Communal noncommercial enterprise of Lviv regional council "Lviv oncological regional therapeutica

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Dose Escalation

Dose Finding Endocrine Therapy 1 Combination

Dose Finding Endocrine Therapy 2 Combination

Dose Expansion Arm A

Dose Expansion Arm B

Dose Expansion Arm C

Dose Expansion Arm D

Dose Expansion Arm E

Arm Description

Single Agent Dose Escalation

Part 1B PF-06873600 plus Endocrine Therapy 1

Part 1B PF-06873600 plus Endocrine Therapy 2

PF-06873600 as a Single Agent

PF-06873600 as a Single Agent in Various Tumor Types

PF-06873600 in Combination with Endocrine Therapy 1

PF-06873600 in Combination with Endocrine Therapy 1

PF-06873600 in Combination with Endocrine Therapy 2

Outcomes

Primary Outcome Measures

Number of patients with dose limiting toxicities in the Dose Escalation portion
Safety and Tolerability as assessed by adverse event monitoring for patients enrolled in the Dose Escalation, Dose Finding and Dose Expansion Arms
Adverse events
Safety and Tolerability as assessed through monitoring of hematology and blood chemistry laboratory assessments for patients enrolled in the Dose Escalation, Dose Finding Portion and the Dose Expansion Arms
safety laboratory abnormalities
Safety and Tolerability as assessed through vital sign monitoring for patients enrolled in the Dose Escalation, Dose Finding Portion and the Dose Expansion Arms
vital signs
Safety and Tolerability as assessed by heart rate corrected QT interval for patients enrolled in the Dose Escalation, Dose Finding Portion and the Dose Expansion Arms
heart rate corrected QT interval
Objective Response Rate (ORR) observed in patients in the Dose Expansion Arms
Number of patients in each Arm. ORR (number of patients with a Partial Response (PR) + Complete Response (CR) relative to the number of evaluable patients
Safety and Tolerability as assessed through monitoring of coagulation laboratory assessments for patients enrolled in the Dose Escalation, Dose Finding Portion and the Dose Expansion Arms
safety laboratory abnormalities
Safety and Tolerability as assessed through monitoring of urinalysis laboratory assessments for patients enrolled in the Dose Escalation, Dose Finding Portion and the Dose Expansion Arms
safety laboratory abnormalities

Secondary Outcome Measures

Single Dose: Maximal concentration (Cmax) in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Pharmacokinetic (PK) assessments for PF-06873600
Single Dose: Plasma concentrations with and without food observed in patients enrolled in one of the single agent Dose Expansion Arms
Single Dose: Time to Maximum Plasma Concentration (Tmax) in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Pharmacokinetic (PK) assessments for PF-06873600
Single Dose: Area Under the Plasma Concentration Versus Time Curve from Time Zero to the Last Sampling Time Point Within the Dose Interval (AUClast) in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Pharmacokinetic (PK) assessments for PF-06873600
Single Dose: Area Under the Plasma Concentration Versus Time Curve from Time Zero Extrapolated to Infinity (AUCinf) in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Pharmacokinetic (PK) assessments for PF-06873600
Single Dose: Apparent Oral Plasma Clearance (CL/F) in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Pharmacokinetic (PK) assessments for PF-06873600
Single Dose: Apparent Volume of Distribution (Vz/F) in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Pharmacokinetic (PK) assessments for PF-06873600
Single Dose: Terminal Elimination Half-Life (t1/2) in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Pharmacokinetic (PK) assessments for PF-06873600
Multiple Dose: Steady State Maximal Concentration (Css,max) in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Pharmacokinetic (PK) assessments for PF-06873600
Multiple Dose: Time to Maximum Plasma Concentration at Steady State (Tss,max) in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Pharmacokinetic (PK) assessments for PF-06873600
Multiple Dose: Area Under the Plasma Concentration Versus Time Curve Within One Dose Interval (AUCss,t) in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Pharmacokinetic (PK) assessments for PF-06873600
Multiple Dose: Steady State Minimum Plasma Concentration (Css,min) in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Pharmacokinetic (PK) assessments for PF-06873600
Multiple Dose: Steady State Apparent Oral Plasma Clearance (CLss/F) in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Pharmacokinetic (PK) assessments for PF-06873600
Multiple Dose: Apparent Volume of Distribution at Steady State (Vss/F) in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Pharmacokinetic (PK) assessments for PF-06873600
Multiple Dose: Terminal Elimination Half-Life (t1/2) in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Pharmacokinetic (PK) assessments for PF-06873600
Multiple Dose: Accumulation Ratio (Rac (AUCss,t /AUCsd,t)) in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Pharmacokinetic (PK) assessments for PF-06873600
Tumor Response observed in patients in Dose Escalation and Dose Finding portion
Duration of Response (DOR) in patients enrolled in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Progression Free Survival (PFS) observed in patients in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Time to Progression (TTP) observed in patients enrolled in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Overall Survival observed in patients enrolled in the Dose Expansion Arms
Pharmacodynamic (PD) biomarkers (pRb and Ki67) in tumor tissue in patients enrolled in the Dose Escalation and Dose Finding portion and Dose Expansion Arms

Full Information

First Posted
February 22, 2018
Last Updated
August 1, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03519178
Brief Title
A Study of PF-06873600 in People With Cancer
Official Title
PHASE 1/2A DOSE ESCALATION AND EXPANSION STUDY EVALUATING SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMICS AND ANTI-TUMOR ACTIVITY OF PF-06873600 AS A SINGLE AGENT AND IN COMBINATION WITH ENDOCRINE THERAPY
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 7, 2018 (Actual)
Primary Completion Date
April 5, 2023 (Actual)
Study Completion Date
November 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is a Phase 1/2a, open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamic study of PF-06873600 administered as a single agent in sequential dose levels and then in combination with endocrine therapy. In Part 1A and Part 1C, successive cohorts of patients will receive escalating doses of PF-06873600 and then in dose finding (Part 1B) with PF-06873600 in combination with endocrine therapy (ET). This study contains 2 parts, dose escalation with single agent (Part 1A and 1C) and then dose finding with PF-06873600 in combination with endocrine therapy (Part 1B) followed by dose expansion arms of PF-06873600 in combination with endocrine therapy (Part 2).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation
Arm Type
Experimental
Arm Description
Single Agent Dose Escalation
Arm Title
Dose Finding Endocrine Therapy 1 Combination
Arm Type
Experimental
Arm Description
Part 1B PF-06873600 plus Endocrine Therapy 1
Arm Title
Dose Finding Endocrine Therapy 2 Combination
Arm Type
Experimental
Arm Description
Part 1B PF-06873600 plus Endocrine Therapy 2
Arm Title
Dose Expansion Arm A
Arm Type
Experimental
Arm Description
PF-06873600 as a Single Agent
Arm Title
Dose Expansion Arm B
Arm Type
Experimental
Arm Description
PF-06873600 as a Single Agent in Various Tumor Types
Arm Title
Dose Expansion Arm C
Arm Type
Experimental
Arm Description
PF-06873600 in Combination with Endocrine Therapy 1
Arm Title
Dose Expansion Arm D
Arm Type
Experimental
Arm Description
PF-06873600 in Combination with Endocrine Therapy 1
Arm Title
Dose Expansion Arm E
Arm Type
Experimental
Arm Description
PF-06873600 in Combination with Endocrine Therapy 2
Intervention Type
Drug
Intervention Name(s)
PF-06873600
Intervention Description
PF-06873600 tablet for oral dosing
Intervention Type
Drug
Intervention Name(s)
Endocrine Therapy 1
Intervention Description
Endocrine Therapy 1
Intervention Type
Drug
Intervention Name(s)
Endocrine Therapy 2
Intervention Description
Endocrine Therapy 2
Primary Outcome Measure Information:
Title
Number of patients with dose limiting toxicities in the Dose Escalation portion
Time Frame
up to 28 days
Title
Safety and Tolerability as assessed by adverse event monitoring for patients enrolled in the Dose Escalation, Dose Finding and Dose Expansion Arms
Description
Adverse events
Time Frame
Weekly during Cycle 1 (each cycle is 28 days) and 2 and then every 28 days through study completion, up to approximately 24 months
Title
Safety and Tolerability as assessed through monitoring of hematology and blood chemistry laboratory assessments for patients enrolled in the Dose Escalation, Dose Finding Portion and the Dose Expansion Arms
Description
safety laboratory abnormalities
Time Frame
Weekly during Cycle 1 (each cycle is 28 days) and 2 and then every 28 days through study completion, up to approximately 24 months
Title
Safety and Tolerability as assessed through vital sign monitoring for patients enrolled in the Dose Escalation, Dose Finding Portion and the Dose Expansion Arms
Description
vital signs
Time Frame
Weekly during Cycle 1 (each cycle is 28 days) and 2 and then every 28 days through study completion, up to approximately 24 months
Title
Safety and Tolerability as assessed by heart rate corrected QT interval for patients enrolled in the Dose Escalation, Dose Finding Portion and the Dose Expansion Arms
Description
heart rate corrected QT interval
Time Frame
Day 1, 8 and 15 of Cycle 1 (each cycle is 28 days) and then every 28 days through study completion, up to approximately 24 months
Title
Objective Response Rate (ORR) observed in patients in the Dose Expansion Arms
Description
Number of patients in each Arm. ORR (number of patients with a Partial Response (PR) + Complete Response (CR) relative to the number of evaluable patients
Time Frame
baseline up to approximately 24 months
Title
Safety and Tolerability as assessed through monitoring of coagulation laboratory assessments for patients enrolled in the Dose Escalation, Dose Finding Portion and the Dose Expansion Arms
Description
safety laboratory abnormalities
Time Frame
Day 1 of Cycle 1 (each cycle is 28 days) and 2 and at completion, approximately 24 months
Title
Safety and Tolerability as assessed through monitoring of urinalysis laboratory assessments for patients enrolled in the Dose Escalation, Dose Finding Portion and the Dose Expansion Arms
Description
safety laboratory abnormalities
Time Frame
Screening and at completion, approximately 24 months
Secondary Outcome Measure Information:
Title
Single Dose: Maximal concentration (Cmax) in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Description
Pharmacokinetic (PK) assessments for PF-06873600
Time Frame
Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Title
Single Dose: Plasma concentrations with and without food observed in patients enrolled in one of the single agent Dose Expansion Arms
Time Frame
7 days prior to Cycle 1 (each cycle is 28 days) and in Cycle 1 (each cycle is 28 days)
Title
Single Dose: Time to Maximum Plasma Concentration (Tmax) in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Description
Pharmacokinetic (PK) assessments for PF-06873600
Time Frame
Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Title
Single Dose: Area Under the Plasma Concentration Versus Time Curve from Time Zero to the Last Sampling Time Point Within the Dose Interval (AUClast) in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Description
Pharmacokinetic (PK) assessments for PF-06873600
Time Frame
Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Title
Single Dose: Area Under the Plasma Concentration Versus Time Curve from Time Zero Extrapolated to Infinity (AUCinf) in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Description
Pharmacokinetic (PK) assessments for PF-06873600
Time Frame
Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Title
Single Dose: Apparent Oral Plasma Clearance (CL/F) in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Description
Pharmacokinetic (PK) assessments for PF-06873600
Time Frame
Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Title
Single Dose: Apparent Volume of Distribution (Vz/F) in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Description
Pharmacokinetic (PK) assessments for PF-06873600
Time Frame
Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Title
Single Dose: Terminal Elimination Half-Life (t1/2) in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Description
Pharmacokinetic (PK) assessments for PF-06873600
Time Frame
Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Title
Multiple Dose: Steady State Maximal Concentration (Css,max) in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Description
Pharmacokinetic (PK) assessments for PF-06873600
Time Frame
Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Title
Multiple Dose: Time to Maximum Plasma Concentration at Steady State (Tss,max) in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Description
Pharmacokinetic (PK) assessments for PF-06873600
Time Frame
Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Title
Multiple Dose: Area Under the Plasma Concentration Versus Time Curve Within One Dose Interval (AUCss,t) in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Description
Pharmacokinetic (PK) assessments for PF-06873600
Time Frame
Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Title
Multiple Dose: Steady State Minimum Plasma Concentration (Css,min) in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Description
Pharmacokinetic (PK) assessments for PF-06873600
Time Frame
Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Title
Multiple Dose: Steady State Apparent Oral Plasma Clearance (CLss/F) in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Description
Pharmacokinetic (PK) assessments for PF-06873600
Time Frame
Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Title
Multiple Dose: Apparent Volume of Distribution at Steady State (Vss/F) in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Description
Pharmacokinetic (PK) assessments for PF-06873600
Time Frame
Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Title
Multiple Dose: Terminal Elimination Half-Life (t1/2) in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Description
Pharmacokinetic (PK) assessments for PF-06873600
Time Frame
Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Title
Multiple Dose: Accumulation Ratio (Rac (AUCss,t /AUCsd,t)) in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Description
Pharmacokinetic (PK) assessments for PF-06873600
Time Frame
Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Title
Tumor Response observed in patients in Dose Escalation and Dose Finding portion
Time Frame
baseline up to approximately 24 months
Title
Duration of Response (DOR) in patients enrolled in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Time Frame
baseline up to approximately 24 months
Title
Progression Free Survival (PFS) observed in patients in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Time Frame
baseline up to approximately 24 months
Title
Time to Progression (TTP) observed in patients enrolled in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Time Frame
baseline up to approximately 24 months
Title
Overall Survival observed in patients enrolled in the Dose Expansion Arms
Time Frame
baseline up to approximately 24 months
Title
Pharmacodynamic (PD) biomarkers (pRb and Ki67) in tumor tissue in patients enrolled in the Dose Escalation and Dose Finding portion and Dose Expansion Arms
Time Frame
Screening, Cycle 1 (each cycle is 28 days), Cycle 2 and 3 and at the study completion visit, up to approximately 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University Of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
HonorHealth Research Institute
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
HonorHealth
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Virginia G. Piper Cancer Center Pharmacy
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Highlands Oncology Group
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Highlands Oncology Group
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Highlands Oncology Group
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Facility Name
Highlands Oncology
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Facility Name
The Oncology Institute of Hope and Innovation
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
The Oncology Institute of Hope and Innovation
City
Long Beach
State/Province
California
ZIP/Postal Code
90805
Country
United States
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
UCSF Investigational Drugs Pharmacy
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
The Oncology Institute of Hope and Innovation
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
UCLA Hematology/Oncology - Parkside
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
UCLA Hematology/Oncology - Santa Monica
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
The Oncology Institute of Hope and Innovation
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Facility Name
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
UCHealth Lone Tree Medical Center
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
Long Island City
State/Province
New York
ZIP/Postal Code
11101
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
The Sarah Cannon Research Institute-Pharmacy
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
The Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
South Texas Accelerated Research Therapeutics, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Northwest Medical Specialties, PLLC
City
Federal Way
State/Province
Washington
ZIP/Postal Code
98003
Country
United States
Facility Name
Northwest Medical Specialties, PLLC
City
Gig Harbor
State/Province
Washington
ZIP/Postal Code
98332
Country
United States
Facility Name
Rainier Hematology-Oncology PC
City
Puyallup
State/Province
Washington
ZIP/Postal Code
98373
Country
United States
Facility Name
Rainier Hematology-Oncology, PC
City
Puyallup
State/Province
Washington
ZIP/Postal Code
98373
Country
United States
Facility Name
Fred Hutchinson Cancer Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Northwest Medical Specialties, PLLC
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Multiprofile Hospital of Active Treatment - Dobrich AD
City
Dobrich
ZIP/Postal Code
9300
Country
Bulgaria
Facility Name
Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD
City
Haskovo
ZIP/Postal Code
6300
Country
Bulgaria
Facility Name
Complex Oncology Center -Plovdiv
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
National Cancer Center Hospital East
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Kanagawa cancer center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
2418515
Country
Japan
Facility Name
Private Medical Institution "Euromedservice"
City
Pushkin
State/Province
Saint-petersburg
ZIP/Postal Code
196603
Country
Russian Federation
Facility Name
BIH of Omsk Region "Clinical Oncological Dispensary"
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
BIH of Omsk Region "Clinical Oncological Dispensary"
City
Omsk
ZIP/Postal Code
644046
Country
Russian Federation
Facility Name
LLC "Medicina Severnoy Stolitsy"
City
Saint-Petersburg
ZIP/Postal Code
191025
Country
Russian Federation
Facility Name
LLC "Severo-Zapadny Medical Center"
City
Saint-Petersburg
ZIP/Postal Code
192007
Country
Russian Federation
Facility Name
Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council, "Dnipro State Me
City
Dnipro
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Kharkiv Regional Specialized Dispensary of Radiation Protection of the Population
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61166
Country
Ukraine
Facility Name
Communal nonprofit enterprise "Kyiv City Clinical Oncology Center" of Executive Body of Kyiv City
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Communal noncommercial enterprise of Lviv regional council "Lviv oncological regional therapeutica
City
Lviv
ZIP/Postal Code
79031
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C3661001
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Study of PF-06873600 in People With Cancer

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