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NCT04504331 · ClinicalTrials.gov registry record · Phase 1
Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer
A Phase 1 study, sponsored by Jennifer Lee Caswell-Jin.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT04504331: Clinical Trial Phase 1 study, sponsored by Jennifer Lee Caswell-Jin.
NCT04504331 is a Phase 1 study that was terminated before completion, run by Jennifer Lee Caswell-Jin. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04504331, a Phase 1 study, was terminated before completion, sponsored by Jennifer Lee Caswell-Jin.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
The purpose of the study is identify the dose(s) of infigratinib to use in combination with tamoxifen to treat patients with a particular type of advanced breast cancer (hormone receptor-positive, HER2-negative, FGFR-altered breast cancer)
Primary Outcome
The primary outcome for this study is dose-limiting toxicities (DLTs) during the first 2 cycles of therapy. All grades per the Common Terminology Criteria for Adverse Events (CTCAE). DLT is defined as a related and clinically significant adverse event (AE), including missed doses due to a related AE.
Interventions
- DRUG Tamoxifen
- DIAGNOSTIC_TEST Computed tomography (CT)
- DRUG Iopamidol
- DRUG Infigratinib
- DRUG Omnipaque 350
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2020-10-13 |
| Est. Completion | 2021-10-22 |
| Phase | Phase 1 |
Why NCT04504331 stopped before completion
NCT04504331 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 5 interventions - of which Tamoxifen is the first listed.
NCT04504331 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04504331 about?
NCT04504331 is a clinical study titled "Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer". The purpose of the study is identify the dose(s) of infigratinib to use in combination with tamoxifen to treat patients with a particular type of advanced breast cancer (hormone receptor-positive, HER2-negative, FGFR-altered breast cancer)
What is the current status of trial NCT04504331?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2020-10-13. Estimated completion is 2021-10-22.
What interventions are being tested in trial NCT04504331?
The interventions under investigation include: Tamoxifen (DRUG), Computed tomography (CT) (DIAGNOSTIC_TEST), Iopamidol (DRUG), Infigratinib (DRUG), Omnipaque 350 (DRUG).
Who is sponsoring clinical trial NCT04504331?
This trial is sponsored by Jennifer Lee Caswell-Jin, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04504331's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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