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NCT03854903 · ClinicalTrials.gov registry record · Phase 1
WI231696: Bosutinib, Palbocicilib and Fulvestrant for HR+HER2- Advanced Breast Cancer Refractory to a CDK4/6 Inhibitor
A Phase 1 study, sponsored by Georgetown University.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT03854903: Completed Phase 1 study, sponsored by Georgetown University.
NCT03854903 is a Phase 1 study that has completed, run by Georgetown University. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03854903, a Phase 1 study, has completed, sponsored by Georgetown University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
This is an open-label, single-arm, phase I trial. It is designed with a conservative dose escalation plan to ensure patient's safety and with a strong translational component to inform if target inhibition is achieved. With concerns regarding safety, based on extensive available pharmacokinetic data and clinical efficacy experience, bosutinib will be given 5-days in a row followed by 2 days rest in a weekly basis, instead of daily. The protocol will enroll patients per 3+3 escalation design. The Dose Limiting Toxicity (DLT) observation period is 28 days. At the end of DLT observation period of each cohort of 3 patients, decision will be made regarding further escalation or de-escalation according to this plan. Once the MTD of the combination is reached, the safety data will be analyzed. There will be no dose reductions during DLT observation period. Dose reduction within patients (individually) is allowed after the 4-week DLT observation period. Treatment in this phase I trial will be administered until there is disease progression or unacceptable toxicity.
Primary Outcome
Toxicity of adverse events will be measured via the Common Toxicity Criteria for Adverse Events (CTCAE 4.03)
Interventions
- DRUG Fulvestrant
- DRUG Palbociclib
- DRUG Bosutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2019-04-01 |
| Est. Completion | 2025-01-09 |
| Phase | Phase 1 |
What the finished NCT03854903 record still lists
NCT03854903 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 3 interventions - of which Fulvestrant is the first listed.
NCT03854903 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03854903 about?
NCT03854903 is a clinical study titled "WI231696: Bosutinib, Palbocicilib and Fulvestrant for HR+HER2- Advanced Breast Cancer Refractory to a CDK4/6 Inhibitor". This is an open-label, single-arm, phase I trial. It is designed with a conservative dose escalation plan to ensure patient's safety and with a strong translational component to inform if target inhibition is achieved. With concerns regarding safety, based on extensive available pharmacokinetic data...
What is the current status of trial NCT03854903?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2019-04-01. Estimated completion is 2025-01-09.
What interventions are being tested in trial NCT03854903?
The interventions under investigation include: Fulvestrant (DRUG), Palbociclib (DRUG), Bosutinib (DRUG).
Who is sponsoring clinical trial NCT03854903?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03854903's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 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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