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NCT04557449 · ClinicalTrials.gov registry record · Phase 2
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
A Phase 2 study of Prostate Cancer and Breast Neoplasms, sponsored by Pfizer.
- Active
- Registry status
- Phase 2
- Development phase
- 362
- Enrollment target
- 20
- Study locations
NCT04557449: Active Phase 2 study of Prostate Cancer and Breast Neoplasms, sponsored by Pfizer.
NCT04557449 is a Phase 2 study of Prostate Cancer and Breast Neoplasms that is active but no longer recruiting, run by Pfizer. The registered enrollment target is 362 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (40% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04557449, a Phase 2 study of Prostate Cancer and Breast Neoplasms, is active but no longer recruiting, sponsored by Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 362 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 1/2A, open label, multicenter, nonrandomized, multiple dose, safety, tolerability, pharmacokinetic and pharmacodynamic study of PF-07220060 administered as a single agent and then in combination with endocrine therapy. The study consists of two parts and a China and Japan monotherapy cohort. Part 1 includes dose escalation cohorts evaluating PF-07220060 as single agent or in combination with endocrine therapy or enzalutamide, as well as a food effect cohort and a DDI cohort Part 2 includes dose expansion cohorts evaluating PF-07220060 in combination with endocrine therapy or enzalutamide. In Part 1A, single escalating doses of PF-07220060 alone will be administered to determine the maximum tolerated dose (MTD) and select the recommended dose for expansion In Part 1B and Part 1C, PF-07220060 will be administered in combination with 1 of 2 endocrine therapies (letrozole and fulvestrant, respectively). In Part 1D, food effect assessment of PF-07220060 at the RP2D dose level from the Part 1A will be conducted In Part 1E, the effect of PF-07220060 on the PK of midazolam will be evaluated (DDI) In Part 1F, escalating dosed of PF-07220060 will be administered in combination with enzalutamide Part 1B and Part 1C may commence at MTD or before reaching the MTD at a dose level in Part 1A. Part 2A is a dose expansion cohort with fulvestrant and will explore more than one dose of PF-07220060 in participants diagnosed with mBC. Part 2B and Part 2C are expansion for combination therapy of PF-07220060 with letrozole and fulvestrant, respectively. Part 2D is the expansion cohort for combination therapy of PF-07220060 with enzalutamide. Part 2E is an expansion cohort to evaluate PF-07220060 Monotherapy versus PF-07220060 plus fulvestrant combination therapy. The China monotherapy cohort will evaluate safety, tolerability and PK of PF-07220060 administered as single agent in Chinese participants. The Japan monotherapy cohort will evaluate safety, tolerability a
Primary Outcome
First cycle (28 days) dose limiting toxicities (Parts 1A, 1B, 1C, 1F)
Conditions Studied
Interventions
- DRUG Midazolam
- COMBINATION_PRODUCT Enzalutamide
- DRUG PF-07220060
- COMBINATION_PRODUCT Letrozole
- COMBINATION_PRODUCT Fulvestrant
Study Locations (20)
Connecticut
- Smilow Cancer Hospital at Yale - New Haven - New Haven
- Yale-New Haven Hospital-Yale Cancer Center - New Haven
- Smilow Cancer Hospital Phase 1 Unit - New Haven
Massachusetts
- Brigham & Women's Hospital - Boston
- Dana-Farber Cancer Institute - Boston
- Dana Farber Cancer Institute- Chestnut Hill - Newton
Other
- Fundación Respirar - Buenos Aires
- Clínica Universitaria Reina Fabiola - Córdoba
- Fundación CORI para la Investigación y Prevención del Cáncer - La Rioja
Tennessee
- Sarah Cannon Research Institute - Pharmacy - Nashville
- SCRI Oncology Partners - Nashville
California
- Ellison Institute - Los Angeles
Michigan
- START Midwest - Grand Rapids
Texas
- The University of Texas MD Anderson Cancer Center - Houston
Buenos Aires
- Hospital Británico de Buenos Aires - Ciudad Autónoma de Buenos Aires
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 362 participants |
| Start Date | 2020-09-23 |
| Est. Completion | 2027-11-23 |
| Phase | Phase 2 |
What the registry record for NCT04557449 still lists
NCT04557449 is an interventional study that assigns participants to a tested intervention. The registered 362 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (40% lower).
The record links to 4 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 5 interventions - of which Midazolam is the first listed.
NCT04557449 names 20 study sites across 13 states, led by Connecticut, Massachusetts, Other.
Frequently Asked Questions
What is clinical trial NCT04557449 about?
NCT04557449 is a clinical study titled "Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors". This is a Phase 1/2A, open label, multicenter, nonrandomized, multiple dose, safety, tolerability, pharmacokinetic and pharmacodynamic study of PF-07220060 administered as a single agent and then in combination with endocrine therapy. The study consists of two parts and a China and Japan monotherap...
What is the current status of trial NCT04557449?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 362 participants. The study started on 2020-09-23. Estimated completion is 2027-11-23.
What conditions does trial NCT04557449 study?
This clinical trial studies the following conditions: Prostate Cancer, Breast Neoplasms, Liposarcoma, Adenocarcinoma of Lung.
What interventions are being tested in trial NCT04557449?
The interventions under investigation include: Midazolam (DRUG), Enzalutamide (COMBINATION_PRODUCT), PF-07220060 (DRUG), Letrozole (COMBINATION_PRODUCT), Fulvestrant (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04557449?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04557449 being conducted?
This trial has 20 study locations across California, Connecticut, Massachusetts, Michigan, Tennessee. 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 NCT04557449's enrollment target sits among peer trials
362 143rd of 735 higher than 593 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate 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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