A Safety, Pharmacokinetic, Pharmacodynamic and Anti-Tumor Study of PF-06873600 as a Single Agent and in Combination With Endocrine Therapy



Status:Recruiting
Conditions:Breast Cancer, Ovarian Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:March 7, 2018
End Date:December 12, 2021
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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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

Open-label, multi-center, non-randomized, multiple dose, safety, tolerability,
pharmacokinetic, and pharmacodynamics and clinical activity study of PF-06873600 administered
as a single agent and then in combination with endocrine therapy. The study contains two
parts, a Part 1 single agent dose escalation and combination endocrine therapy dose finding
component and a Part 2 dose expansion as both a single agent and in combination with
endocrine therapy.

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, 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 then dose finding
with PF-06873600 in combination with endocrine therapy (Part 1B) followed by dose expansion
arms as a single agent and PF-06873600 in combination with endocrine therapy (Part 2).

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 2)

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
We found this trial at
10
sites
Santa Monica, California 90404
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Houston, Texas 77030
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Los Angeles, California 90095
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Los Angeles, California 90095
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Nashville, TN
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Nashville, TN
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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San Francisco, California 94115
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San Francisco, California 94143
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San Francisco, CA
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