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PF-07104091 for Breast Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with cytological diagnosis of advanced/metastatic SCLC
Participants with locally recurrent/advanced or metastatic TNBC who have received up to 2 prior lines of chemotherapy in the advanced or metastatic setting
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline and every 8 weeks through disease progression or study completion (approximately 2 years)
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and how well it works against different types of cancer.

Who is the study for?
This trial is for adults with certain advanced cancers: small cell lung cancer (SCLC), ovarian, or breast cancer. Participants must have a performance status of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but can do light work. They should have received prior treatments specific to their cancer type and must not have any serious heart conditions, uncontrolled infections, recent major surgeries, other active malignancies within the last three years, or be pregnant.Check my eligibility
What is being tested?
The trial tests different doses and combinations of PF-07104091 to find the safest and most effective dose for treating advanced cancers. It includes monotherapy (PF-07104091 alone) and combination therapies with drugs like fulvestrant and palbociclib. The goal is to determine the maximum tolerated dose (MTD) and/or recommend a Phase 2 dose (RP2D).See study design
What are the potential side effects?
Potential side effects may include typical reactions from cancer medications such as nausea, fatigue, blood count changes leading to increased infection risk or bleeding tendencies. Specific side effects related to PF-07104091 aren't detailed but could align with common chemotherapy-related adverse events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is small cell lung cancer and has spread.
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I have TNBC and received up to 2 chemotherapy treatments for advanced cancer.
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My breast cancer is HR-positive, HER2-negative, and has spread.
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My lung cancer has spread to other parts of my body.
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I have ovarian, fallopian tube, or peritoneal cancer that didn't respond to platinum-based treatment.
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I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My breast cancer is HR-positive, HER2-negative, and I've had specific previous treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline and every 8 weeks through disease progression or study completion (approximately 2 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline and every 8 weeks through disease progression or study completion (approximately 2 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Escalation: Number of participants with Dose-limiting toxicities (DLT) during first cycle
Evaluate blood pressure that is out of normal range and changes in blood pressure as compared to baseline
Evaluate pulse rate that is out of normal range and changes in pulse rate as compared to baseline
+3 more
Secondary outcome measures
Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) of PF-07104091
Area under the curve of PF-07104091 with or without food
Maximum plasma concentration (Cmax) of PF-07104091 after a single dose and multiple dose
+4 more

Trial Design

7Treatment groups
Experimental Treatment
Group I: PF-07104091 monotherapy dose expansion (ovarian)Experimental Treatment1 Intervention
PF-07104091 monotherapy dose expansion (ovarian)
Group II: PF-07104091 monotherapy dose expansion (SCLC)Experimental Treatment1 Intervention
PF-07104091 monotherapy dose expansion (SCLC)
Group III: PF-07104091 + palbociclib + letrozoleExperimental Treatment1 Intervention
CDK2 + palbociclib + letrozole
Group IV: PF-07104091 + palbociclib + fulvestrantExperimental Treatment1 Intervention
CDK2 + palbociclib + fulvestrant
Group V: PF-07104091 + fulvestrant (post CDK4/6) dose expansionExperimental Treatment1 Intervention
PF-07104091 + fulvestrant (post CDK4/6) dose expansion
Group VI: PF-07104091 + fulvestrant (post CDK 4/6) dose escalationExperimental Treatment1 Intervention
CDK2+ fulvestrant (post CDK 4/6) dose escalation
Group VII: PF-07104091Experimental Treatment1 Intervention
CDK2 monotherapy dose escalation

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,570 Previous Clinical Trials
10,910,158 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,475 Previous Clinical Trials
8,091,272 Total Patients Enrolled

Media Library

PF-07104091 monotherapy dose expansion (ovarian) Clinical Trial Eligibility Overview. Trial Name: NCT04553133 — Phase 1 & 2
Small Cell Lung Cancer Research Study Groups: PF-07104091 + palbociclib + letrozole, PF-07104091 + palbociclib + fulvestrant, PF-07104091 monotherapy dose expansion (ovarian), PF-07104091 + fulvestrant (post CDK4/6) dose expansion, PF-07104091 + fulvestrant (post CDK 4/6) dose escalation, PF-07104091, PF-07104091 monotherapy dose expansion (SCLC)
Small Cell Lung Cancer Clinical Trial 2023: PF-07104091 monotherapy dose expansion (ovarian) Highlights & Side Effects. Trial Name: NCT04553133 — Phase 1 & 2
PF-07104091 monotherapy dose expansion (ovarian) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04553133 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How widespread is the availability of this research endeavor?

"Right now, this medical study is accepting participants across 22 locations. These include Louisville, Middletown and Houston - as well as other local centres. Prospective patients should consider the nearest site to reduce transport needs if they join the trial."

Answered by AI

What is the upper limit of participants in this medical study?

"In order to adequately assess the efficacy of this treatment, we need 240 volunteers who meet all specified requirements. For those interested in taking part, research can be conducted at two different locations: Dana Farber Cancer Institute located in Louisville, Kentucky and Norton Diagnostic Center - Fern Creek situated in Middletown New jersey."

Answered by AI

What illnesses is PF-07104091 monotherapy dose expansion (ovarian) typically used to alleviate?

"Progression-disease is usually managed with the use of PF-07104091 monotherapy dose expansion (ovarian). Besides this, tamoxifen, postmenopause and advance directives can all be treated by employing the same pharmacological approach."

Answered by AI

Are there other experiments that have tested the efficacy of PF-07104091 monotherapy dose expansion (ovarian)?

"Presently, 334 clinical studies are researching PF-07104091 monotherapy dose expansion (ovarian). Of those, 68 currently reside in Phase 3. Remarkably, these trials have expanded to 18632 locations worldwide with the majority of research based out of Shanghai."

Answered by AI

Are researchers presently collecting data for this trial?

"Affirmative. According to clinicaltrials.gov, this investigation is currently recruiting participants and was initially posted on the 16th of September 2020, with its most recent update occurring on April 26th 2022. The research requires 240 individuals who are located in 22 different sites."

Answered by AI

What aims does this research endeavor seek to accomplish?

"According to Pfizer, the study's primary efficacy measure is tracking treatment-associated adverse events and laboratory results occurring over a two year period. Secondary endpoints of interest include peak plasma concentrations with or without food consumption, time taken for drug absorption after both single and multiple doses, as well as signs of antitumor activity in combination with palbociclib and letrozole which will be judged based on RECIST 1.1 criteria."

Answered by AI

Has the FDA approved PF-07104091 as a single drug dose for ovarian treatment?

"Our team has assigned a rating of 2 to the safety profile of PF-07104091 monotherapy dose expansion (ovarian), as clinical data supporting efficacy is still lacking despite some evidence for its safety."

Answered by AI
~50 spots leftby Jan 2025