Breast Cancer Clinical Trial

Study of PF-07248144 in Advanced or Metastatic Solid Tumors

Summary

This is an open-label, multi center study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-07248144 and early signs of clinical efficacy of PF-07248144 as a single agent and in combination with either fulvestrant or letrozole + palbociclib.

View Full Description

Full Description

Study has two parts, Part 1 (dose escalation) and Part 2 (dose expansion). Part 1 is divided into Parts 1A, 1B, and 1C and Part 2 is divided into Parts 2A and 2B. In Part 1A, single escalating doses of PF-07248144 alone will be administered to determine the maximum tolerable dose (MTD) and select the recommended dose for expansion (RDE). In Part 1B and 1C, PF-07248144 will be administered in combination with either fulvestrant or letrozole + palbociclib. After the determination of the monotherapy RDE in Part 1A, PF-07248144 will be evaluated in a dose expansion cohort as a monotherapy in Part 2A.

After determination of the combination RDE from Part 1B, PF-07248144 in combination with fulvestrant, PF-07248144 will be evaluated in a combination dose expansion with fulvestrant in Part 2B. In Part 1C, PF-07248144 in combination with letrozole + palbociclib will be evaluated for dose finding to determine the MTD and RDE for this combination.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Disease Characteristics - Breast, Prostate, and Lung Cancer

Part 1A (Monotherapy Dose Escalation) Histological or cytological diagnosis of locally advanced or metastatic ER+HER2- breast cancer, CRPC, or NSCLC that is intolerant or resistant to standard therapy or for which no standard therapy is available.
Part 1B and Part 1C (Combination Dose Escalation) Histological or cytological diagnosis of locally advanced or metastatic ER+HER2- breast cancer. Participants must have progressed after at least 1 prior line of treatment with an endocrine therapy and CDK4/6 inhibitor in the advanced or metastatic setting.
Part 2A (ER+HER2- breast cancer 2L+, monotherapy) Histological or cytological diagnosis of locally advanced or metastatic ER+HER2- breast cancer. Participants must have progressed after at least 1 prior line of CDK4/6 inhibitor and 1 line of endocrine therapy.
Part 2B (ER+HER2- breast cancer 2-4L, fulvestrant-naive, combination with fulvestrant) Histological or cytological diagnosis of advanced or metastatic ER+HER2- breast cancer. Participants must have progressed after 1 line of a CDK4/6 inhibitor and 1 line of endocrine therapy.
Participants with ER+HER2- advanced or metastatic breast cancer must have documentation of ER-positive tumor (≥1% positive stained cells) based on most recent tumor biopsy utilizing an assay consistent with local standards.
Participants with ER+HER2- advanced or metastatic breast cancer must have documentation of HER2-negative tumor: HER2-negative tumor is determined as immunohistochemistry score 0/1+ or negative by in situ hybridization (FISH/CISH/SISH/DISH) defined as a HER2/CEP17 ratio <2 or for single probe assessment a HER2 copy number <4.
Female participants with ER+HER2- advanced or metastatic breast cancer considered to be of childbearing potential (or have tubal ligations only) must be willing to undergo medically induced menopause by treatment with the approved LHRH agonist such as goserelin, leuprolide or equivalent agents to induce chemical menopause.
Female participants with ER+HER2- advanced or metastatic breast cancer of nonchildbearing potential must meet at least 1 criteria of achieving postmenopausal status.
Participants must have at least 1 measurable lesion as defined by RECIST version 1.1 that has not been previously irradiated.
Eastern Cooperative Oncology Group (ECOG) Performance Status PS 0 or 1
Female or male patients aged ≥ 18 years (Japan ≥ 20 years) (South Korea ≥ 19 years).
Adequate renal, liver, and bone marrow function.
Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade 1 except for adverse events (AEs) not constituting a safety risk by investigator judgment.

Exclusion Criteria:

Unmanageable ascites (limited medical treatment to control ascites is permitted, but all participants with ascites require review by sponsor's medical monitor).
Participants with any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks prior to study entry.
Prior irradiation to >25% of the bone marrow.
ECG clinically relevant abnormalities (eg, QTc >470 msec, complete LBBB, second/third degree AV block, ST elevation or EKG changes suggesting myocardial infarction or active myocardia ischemia).
Therapeutic anticoagulation. However, low molecular weight heparin is allowed. Vitamin K antagonists or factor Xa inhibitors may be allowed following discussion with the Sponsor.
Known or suspected hypersensitivity or severe allergy to active ingredient/excipients of PF-07248144.
Active inflammatory GI disease, refractory and unresolved chronic diarrhea or previous gastric resection, lap band surgery or other GI conditions and surgeries that may significantly alter the absorption of PF-07248144 tablets. Gastroesophageal reflux disease under treatment is allowed.
Pregnant or breastfeeding female participants.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

108

Study ID:

NCT04606446

Recruitment Status:

Recruiting

Sponsor:

Pfizer

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 29 Locations for this study

See Locations Near You

HonorHealth
Scottsdale Arizona, 85258, United States
Cedars Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles California, 90048, United States
Cedars-Sinai Medical Center; SOCCI Pharmacy
Los Angeles California, 90048, United States
UCSF Medical Center at Mission Bay
San Francisco California, 94158, United States
Smilow Cancer Hospital at Yale - New Haven
New Haven Connecticut, 06510, United States
Smilow Cancer Hospital Phase 1 Unit
New Haven Connecticut, 06511, United States
Yale New Haven Hospital
New Haven Connecticut, 06520, United States
Holy Cross Hospital
Fort Lauderdale Florida, 33308, United States
James Graham Brown Cancer Center
Louisville Kentucky, 40202, United States
University Medical Center, lnc.:DBA University of Louisville Hospital
Louisville Kentucky, 40202, United States
Michigan Health Professionals
Farmington Hills Michigan, 48334, United States
Revive Research Institute
Farmington Hills Michigan, 48334, United States
Thomas Jefferson University, Bodine Center for Radiation Therapy
Philadelphia Pennsylvania, 19107, United States
Thomas Jefferson University, Clinical Research Unit
Philadelphia Pennsylvania, 19107, United States
Thomas Jefferson University, Gibbon Building
Philadelphia Pennsylvania, 19107, United States
Thomas Jefferson University, Investigational Drug Service
Philadelphia Pennsylvania, 19107, United States
Thomas Jefferson University, Main Office Building
Philadelphia Pennsylvania, 19107, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization
Philadelphia Pennsylvania, 19107, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia Pennsylvania, 19107, United States
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States
TJU Research PK/PD Lab
Philadelphia Pennsylvania, 19107, United States
Tennessee Oncology PLLC
Franklin Tennessee, 37067, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Tennessee Oncology PLLC
Nashville Tennessee, 37203, United States
The Sarah Cannon Research Institute / Tennessee Oncology, PLLC
Nashville Tennessee, 37203, United States
The University of Texas M. D. Anderson Cancer Center
Houston Texas, 77030, United States
U.T. MD Anderson Cancer Center
Houston Texas, 77030, United States
NEXT Oncology
San Antonio Texas, 78229, United States
Chris O'Brien Lifehouse
Camperdown New South Wales, 2050, Australia
Cancer Research South Australia
Adelaide South Australia, 5000, Australia
Peter MacCallum Cancer Centre
Melbourne Victoria, 3000, Australia
Royal Melbourne Hospital
Melbourne Victoria, 3000, Australia
Western Health-Sunshine & Footscray Hospitals
St Albans Victoria, 3021, Australia
St. John of God Subiaco Hospital
Subiaco Western Australia, 6008, Australia
Aichi Cancer Center Hospital
Nagoya Aichi, 464-8, Japan
National Cancer Center Hospital East
Kashiwa Chiba, 277-8, Japan
Kanagawa cancer center
Yokohama Kanagawa, 24185, Japan
National Cancer Center Hospital
Chuo-ku Tokyo, 104-0, Japan
Seoul National University Bundang Hospital
Seongnam Ky?nggi-do, 13620, Korea, Republic of
Seoul National University Hospital
Seoul Seoul-teukbyeolsi [seoul], 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul Seoul-teukbyeolsi [seoul], 03722, Korea, Republic of
Samsung Medical Center
Seoul Seoul-teukbyeolsi [seoul], 06351, Korea, Republic of
Kyungpook National University Chilgok Hospital
Daegu Taegu-kwangyǒkshi, 41404, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

108

Study ID:

NCT04606446

Recruitment Status:

Recruiting

Sponsor:


Pfizer

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.