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NCT06125522 · ClinicalTrials.gov registry record · Phase 1
TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer. (Sub-Study C)
A Phase 1 study of Breast Cancer, sponsored by Pfizer.
- Active
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 20
- Study locations
NCT06125522: Active Phase 1 study of Breast Cancer, sponsored by Pfizer.
NCT06125522 is a Phase 1 study of Breast Cancer that is active but no longer recruiting, run by Pfizer. The registered enrollment target is 11 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (100% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06125522, a Phase 1 study of Breast Cancer, is active but no longer recruiting, sponsored by Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to learn about the safety and effects of the study medicine called vepdegestrant. The safety and effects of vepdegestrant will be see when given with other medicines. Vepdegestrant is studied to see if it can be a possible treatment for advanced metastatic breast cancer. This type of cancer would have spread from where it started (breast) to other parts of the body and would be tough to treat. The study is seeking for participants who have breast cancer that: * is hard to treat (advanced) and may have spread to other organs (metastatic). is sensitive to hormonal therapy (it is called estrogen receptor positive). * is no longer responding to treatments taken before starting this study. This study is divided into separate sub-studies. For Sub-Study C: All the participants will receive vepdegestrant and a medicine called samuraciclib. Vepdegestrant and samuraciclib will be taken once in a day by mouth. The medicines will be taken at home. The experience of people receiving the study medicines will be studied. This will help see if the study medicine is safe and effective. Participant will continue to take vepdegestrant and samuraciclib until: * their cancer is no longer responding, or * side effects become too severe. They will have visits at the study clinic about every 4 weeks.
Primary Outcome
Dose Limiting Toxicities rate for ARV-471 in combination with Samuraciclib, estimated based on data from DLT-evaluable participants during the DLT observation period (Cycle 1).
Conditions Studied
Interventions
- DRUG vepdegestrant
- DRUG Samuraciclib
Study Locations (20)
Missouri
- Siteman Cancer Center - St Peters - City of Saint Peters
- Siteman Cancer Center - West County - Creve Coeur
- Siteman Cancer Center - North County - Florissant
- Barnes-Jewish Hospital - St Louis
- Washington University School of Medicine - Siteman Cancer Center - St Louis
- Siteman Cancer Center - South County - St Louis
Colorado
- UCHealth Poudre Valley Hospital - Fort Collins
- UCHealth Harmony - Fort Collins
- UCHealth Greeley Hospital - Greeley
- UCHealth - Medical Center of the Rockies - Loveland
Arkansas
- Highlands Oncology Group - Fayetteville
- Highlands Oncology Group - Rogers
- Highlands Oncology Group - Springdale
California
- Clinical and Translational Research Unit (CTRU) - Palo Alto
- Stanford Cancer Center - Palo Alto
Illinois
- Memorial Hospital East - Shiloh
- Siteman Cancer Center - Shiloh - Shiloh
Bruxelles-capitale, Région de
- Institut Jules Bordet - Anderlecht
Côte-d'or
- Centre Georges François Leclerc - Dijon
Lombardy
- Fondazione IRCCS San Gerardo dei Tintori - Monza
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2024-01-10 |
| Est. Completion | 2026-04-30 |
| Phase | Phase 1 |
What the registry record for NCT06125522 still lists
NCT06125522 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which vepdegestrant is the first listed.
NCT06125522 names 20 study sites across 8 states, led by Missouri, Colorado, Arkansas.
Frequently Asked Questions
What is clinical trial NCT06125522 about?
NCT06125522 is a clinical study titled "TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer. (Sub-Study C)". The purpose of this study is to learn about the safety and effects of the study medicine called vepdegestrant. The safety and effects of vepdegestrant will be see when given with other medicines. Vepdegestrant is studied to see if it can be a possible treatment for advanced metastatic breast cancer....
What is the current status of trial NCT06125522?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2024-01-10. Estimated completion is 2026-04-30.
What conditions does trial NCT06125522 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT06125522?
The interventions under investigation include: vepdegestrant (DRUG), Samuraciclib (DRUG).
Who is sponsoring clinical trial NCT06125522?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06125522 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Illinois, Missouri. 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 NCT06125522's enrollment target sits among peer trials
11 1172nd of 1224 higher than 49 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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