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NCT03727750 · ClinicalTrials.gov registry record · Phase 4
Evaluating QTc, PK, Safety of Gemtuzumab Ozogamicin (GO) in Patients With CD33+ R/R AML
A Phase 4 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 4
- Development phase
- 51
- Enrollment target
NCT03727750: Completed Phase 4 study, sponsored by Pfizer.
NCT03727750 is a Phase 4 study that has completed, run by Pfizer. The registered enrollment target is 51 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03727750, a Phase 4 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 51 participants
- Enrollment target
Study Summary
This is a single-arm, open-label, Phase 4 study evaluating the effect of GO on the QTc, pharmacokinetics, safety, and immunogenicity of GO as a single-agent monotherapy in adult and pediatric patients with relapsed or refractory CD33-positive AML.
Primary Outcome
Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported.
Interventions
- DRUG Gemtuzumab Ozogamicin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2019-07-03 |
| Est. Completion | 2021-04-27 |
| Phase | Phase 4 |
What the finished NCT03727750 record still lists
NCT03727750 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Gemtuzumab Ozogamicin is the first listed.
NCT03727750 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03727750 about?
NCT03727750 is a clinical study titled "Evaluating QTc, PK, Safety of Gemtuzumab Ozogamicin (GO) in Patients With CD33+ R/R AML". This is a single-arm, open-label, Phase 4 study evaluating the effect of GO on the QTc, pharmacokinetics, safety, and immunogenicity of GO as a single-agent monotherapy in adult and pediatric patients with relapsed or refractory CD33-positive AML.
What is the current status of trial NCT03727750?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 51 participants. The study started on 2019-07-03. Estimated completion is 2021-04-27.
What interventions are being tested in trial NCT03727750?
The interventions under investigation include: Gemtuzumab Ozogamicin (DRUG).
Who is sponsoring clinical trial NCT03727750?
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 NCT03727750's enrollment target sits among peer trials
51 1249th of 2000 higher than 746 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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