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NCT04553133 · ClinicalTrials.gov registry record · Phase 2
PF-07104091 as a Single Agent and in Combination Therapy
A Phase 2 study of Breast Cancer and Ovarian Cancer, sponsored by Pfizer.
- Active
- Registry status
- Phase 2
- Development phase
- 154
- Enrollment target
- 20
- Study locations
NCT04553133: Active Phase 2 study of Breast Cancer and Ovarian Cancer, sponsored by Pfizer.
NCT04553133 is a Phase 2 study of Breast Cancer and Ovarian Cancer that is active but no longer recruiting, run by Pfizer. The registered enrollment target is 154 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04553133, a Phase 2 study of Breast Cancer and Ovarian Cancer, is active but no longer recruiting, sponsored by Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 154 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Number of participants with DLTs, which are typically Grade 3 or higher adverse events will be summarized by dose level
Conditions Studied
Interventions
- DRUG PF-07104091 monotherapy dose escalation
- DRUG PF-07104091 + palbociclib + fulvestrant
- DRUG PF-07104091 + palbociclib + letrozole
- DRUG PF-07104091 monotherapy dose expansion (ovarian)
- DRUG PF-07104091 monotherapy dose expansion (SCLC)
Study Locations (20)
Kentucky
- Norton Cancer Institute Downtown - Louisville
- Norton Cancer Institute Pharmacy, Downtown Pharmacy - Louisville
- Norton Cancer Institute, Downtown - Louisville
- Norton Hospital - Louisville
- Norton Cancer Institute, St. Matthews - Louisville
- Norton Women's and Children's Hospital (St. Matthews) - Louisville
- Norton Cancer Institute, Audubon - Louisville
- Norton Hospital (Audubon) - Louisville
- Norton Brownsboro Hospital - Louisville
- Norton Cancer Institute, Brownsboro Campus - Louisville
Iowa
- Medical Oncology & Hematology Associates DBA Mission Cancer and Blood - Clive
- Des Moines Oncology Research Association - Des Moines
- Medical Oncology & Hematology Associates DBA Mission Cancer and Blood - Des Moines
- Medical Oncology & Hematology Associates DBA Mission Cancer and Blood - Des Moines
Massachusetts
- Massachusetts General Hospital - Boston
- Brigham & Women's Hospital - Boston
- Dana Farber Cancer Institute - Boston
- Dana-Farber Cancer Institute - Chestnut Hill - Newton
Michigan
- START Midwest - Grand Rapids
New Jersey
- Memorial Sloan Kettering Monmouth - Middletown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2020-09-16 |
| Est. Completion | 2026-03-30 |
| Phase | Phase 2 |
What the registry record for NCT04553133 still lists
NCT04553133 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower).
The record links to 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which PF-07104091 monotherapy dose escalation is the first listed.
NCT04553133 names 20 study sites across 5 states, led by Kentucky, Iowa, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04553133 about?
NCT04553133 is a clinical study titled "PF-07104091 as a Single Agent and in Combination Therapy". 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.
What is the current status of trial NCT04553133?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 154 participants. The study started on 2020-09-16. Estimated completion is 2026-03-30.
What conditions does trial NCT04553133 study?
This clinical trial studies the following conditions: Breast Cancer, Ovarian Cancer, Small-cell Lung Cancer.
What interventions are being tested in trial NCT04553133?
The interventions under investigation include: PF-07104091 monotherapy dose escalation (DRUG), PF-07104091 + palbociclib + fulvestrant (DRUG), PF-07104091 + palbociclib + letrozole (DRUG), PF-07104091 monotherapy dose expansion (ovarian) (DRUG), PF-07104091 monotherapy dose expansion (SCLC) (DRUG).
Who is sponsoring clinical trial NCT04553133?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04553133 being conducted?
This trial has 20 study locations across Iowa, Kentucky, Massachusetts, Michigan, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04553133's enrollment target sits among peer trials
154 440th of 1224 higher than 785 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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