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NCT02687191 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of PF-05230907 in Intracerebral Hemorrhage
A Phase 1 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT02687191 is a Phase 1 study that was terminated before completion, run by Pfizer. The registered enrollment target is 21 participants.
The verdict
NCT02687191, a Phase 1 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
This study employs a modified continual reassessment method (mCRM) design to estimate the maximum tolerated dose (MTD) of PF-05230907, defined as a target toxicity rate of 15% based on treatment emergent thromboembolic and/or ischemic events (TIEs). The mCRM design utilizes Bayesian methodology to continuously learn the dose-toxicity relationship, which is characterized by a parametric model. Subjects with a diagnosis of ICH (determined by computed tomography) will be enrolled in cohorts of 3. The total length of time planned for study participation is approximately 3 months; 6.0 hours for screening, a single dose administration with a 4-day minimum hospital confinement period and follow-up visits through Day 91. Severity of adverse events (AEs) and serious adverse events (SAEs) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. All subjects who receive PF-05230907 are evaluable for TIEs. The determination of MTD using mCRM modeling will be based on TIEs which occur through 7 days post-dose (Day 8).
Interventions
- BIOLOGICAL PF-05230907
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2016-11 |
| Est. Completion | 2018-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02687191
The ClinicalTrials.gov registry entry for NCT02687191 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PF-05230907 is the first listed.
NCT02687191 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02687191 about?
NCT02687191 is a clinical study titled "Safety and Tolerability of PF-05230907 in Intracerebral Hemorrhage". This study employs a modified continual reassessment method (mCRM) design to estimate the maximum tolerated dose (MTD) of PF-05230907, defined as a target toxicity rate of 15% based on treatment emergent thromboembolic and/or ischemic events (TIEs). The mCRM design utilizes Bayesian methodology to c...
What is the current status of trial NCT02687191?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2016-11. Estimated completion is 2018-01.
What interventions are being tested in trial NCT02687191?
The interventions under investigation include: PF-05230907 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02687191?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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