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NCT03284723 · ClinicalTrials.gov registry record · Phase 1
PF-06804103 Dose Escalation in HER2 Positive and Negative (Negative Only in Part 2) Solid Tumors
A Phase 1 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 1
- Development phase
- 95
- Enrollment target
NCT03284723: Clinical Trial Phase 1 study, sponsored by Pfizer.
NCT03284723 is a Phase 1 study that was terminated before completion, run by Pfizer. The registered enrollment target is 95 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03284723, a Phase 1 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 95 participants
- Enrollment target
Study Summary
The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of PF-06804103 in patients with HER2 positive and negative breast and gastric cancer (HER2 positive only and gastric were studied in Part 1A only). The study will expand to look at selected doses in patients with HER2 positive and negative breast cancer.
Primary Outcome
A DLT was any of the following adverse events(AEs) in the first cycle of treatment (within 21 days of first dose). (1) Hematologic: Grade 4 neutropenia lasting \>7 days; febrile neutropenia; Grade \>＝3 neutropenic infection; Grade \>＝3 thrombocytopenia with bleeding; thrombocytopenia; (2) Non-hematologic: Grade \>=3 toxicities that were considered clinically significant; delayed by more than 2 weeks in receiving the next scheduled cycle due to persisting treatment related toxicities; concurrent
Interventions
- DRUG PF-06804103
- DRUG PF-06804103 + Palbociclib +Letrozole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2017-11-01 |
| Est. Completion | 2021-08-31 |
| Phase | Phase 1 |
Why NCT03284723 stopped before completion
NCT03284723 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% higher).
The record links to 0 conditions, and to 2 interventions - of which PF-06804103 is the first listed.
NCT03284723 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03284723 about?
NCT03284723 is a clinical study titled "PF-06804103 Dose Escalation in HER2 Positive and Negative (Negative Only in Part 2) Solid Tumors". The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of PF-06804103 in patients with HER2 positive and negative breast and gastric cancer (HER2 positive only and gastric were studied in Part 1A only). The study will expand to look at selected doses in patient...
What is the current status of trial NCT03284723?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 95 participants. The study started on 2017-11-01. Estimated completion is 2021-08-31.
What interventions are being tested in trial NCT03284723?
The interventions under investigation include: PF-06804103 (DRUG), PF-06804103 + Palbociclib +Letrozole (DRUG).
Who is sponsoring clinical trial NCT03284723?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03284723's enrollment target sits among peer trials
95 610th of 2000 higher than 1,386 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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