PF-07104091 as a Single Agent and in Combination Therapy (NCT04553133) | Clinical Trial Compass
Active — Not RecruitingPhase 2
PF-07104091 as a Single Agent and in Combination Therapy
United States, Argentina, Bulgaria157 participantsStarted 2020-09-16
Plain-language summary
To assess the safety and tolerability of increasing doses of PF-07104091 and to estimate the Maximum Tolerated Dose (MTD) and/or select the Recommended Phase 2 dose (RP2D) for PF-07104091 as a single agent in participants with advanced or metastatic small cell lung, breast and ovarian cancers.
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:
* Participants with HR-positive HER2-negative advanced or metastatic breast cancer (received at least two prior lines in the advanced or metastatic setting including one prior line of combined CDK4/6 inhibitor and endocrine therapy and no more than two prior lines of cytotoxic chemotherapy)
* Participants with locally recurrent/advanced or metastatic TNBC who have received up to 2 prior lines of chemotherapy in the advanced or metastatic setting
* Participants with advanced platinum resistant epithelial ovarian cancer (EOC)/fallopian tube cancer/primary peritoneal cancer (PPC) (histologically or cytologically proven) who have received at least 1 systemic anti-cancer therapy containing a platinum analog
* Participants with cytological diagnosis of advanced/metastatic SCLC
* Participants with or cytological diagnosis of advanced/metastatic NSCLC
* Participants with HR-positive HER2-negative advanced or metastatic breast cancer (second line plus setting) (histologically or cytologically proven).
* Participants entering the study in the expansion cohort have at least one measurable lesion as defined by RECIST version 1.1 that has not been previously irradiated
* Performance Status 0 or 1
* Adequate bone marrow, hematological, kidney and liver function
* Resolved acute effects of any prior therapy to baseline severity
Exclusion Criteria:
* Participants with known symptomatic brain metastases requiring steroids
* Participants with any other active malignancy …
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
1
Dose Escalation: Number of participants with Dose-limiting toxicities (DLT) during first cycle
Timeframe: 28 days
2
To evaluate incidence of treatment emergent adverse events and laboratory abnormalities
Timeframe: From baseline until end of study treatment or study completion (approximately 2 years)
3
Evaluate pulse rate that is out of normal range and changes in pulse rate as compared to baseline
Timeframe: From baseline until end of study treatment or study completion (approximately 2 years)
4
Evaluate blood pressure that is out of normal range and changes in blood pressure as compared to baseline
Timeframe: From baseline until end of study treatment or study completion (approximately 2 years)
5
To evaluate heart rate corrected QT interval and changes in corrected QT interval as compared to baseline
Timeframe: From baseline until end of study treatment or study completion (approximately 2 years)
6
To evaluate the preliminary antitumor activity of PF-07104091 as a single agent and in combination with palbociclib and in combination with letrozole or fulvestrant or fulvestrant alone by objective response rate (ORR) in dose expansion