TerminatedPhase 1/2

A Study of PF-06873600 in People With Cancer

Stopped: Per business decision, but not due to safety concerns or regulatory request.

United States, Bulgaria, Canada155 participantsStarted 2018-03-07

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 gast…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Trial details

NCT IDNCT03519178

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-04-05

Results submitted2024-03-27

View on ClinicalTrials.gov More HR+ HER2- Metastatic Breast Cancer, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Triple Negative Breast Cancer, Male Breast Cancer trials