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NCT02363491 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Study of OPN-305 in Second-line Lower Risk Myelodysplastic Syndrome
A Phase 1 study of Myelodysplastic Syndrome, sponsored by Opsona Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 96
- Enrollment target
- 4
- Study locations
NCT02363491 is a Phase 1 study of Myelodysplastic Syndrome that has completed, run by Opsona Therapeutics. The registered enrollment target is 96 participants, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (54% lower). The trial reports 4 study locations across 3 states.
The verdict
NCT02363491, a Phase 1 study of Myelodysplastic Syndrome, has completed, sponsored by Opsona Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 96 participants
- Enrollment target
- 4
- Study locations
Study Summary
The dose-confirming part of this study, comprising at least 10 patients is designed as a single center, prospective, single arm, open label in patients who have failed or are unresponsive to Azacitidine (AZA) or Decitabine (they may also have additionally failed an Erythropoiesis Stimulating Agent (ESA) followed by a dose expansion part with at least 44 patients; the objective of the whole study being to assess the safety, efficacy, pharmacokinetics and pharmacodynamics of intravenously infused multiple doses of OPN-305 in low and intermediate-1 risk myelodysplastic syndrome (second and third line Lower risk MDS).
Conditions Studied
Interventions
- DRUG OPN-305
Study Locations (4)
New York
- Research Site - New York
- Research Site - The Bronx
Florida
- Research Site - Tampa
Texas
- Research Site - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2015-01 |
| Est. Completion | 2018-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02363491
The ClinicalTrials.gov registry entry for NCT02363491 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (54% lower). The listed sponsor is Opsona Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Myelodysplastic Syndrome appearing as the primary indexed condition, and to 1 intervention - of which OPN-305 is the first listed.
NCT02363491 reports 4 study locations spanning 3 distinct geographic areas - top geographies include New York, Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT02363491 about?
NCT02363491 is a clinical study titled "A Phase I/II Study of OPN-305 in Second-line Lower Risk Myelodysplastic Syndrome". The dose-confirming part of this study, comprising at least 10 patients is designed as a single center, prospective, single arm, open label in patients who have failed or are unresponsive to Azacitidine (AZA) or Decitabine (they may also have additionally failed an Erythropoiesis Stimulating Agent (...
What is the current status of trial NCT02363491?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 96 participants. The study started on 2015-01. Estimated completion is 2018-12.
What conditions does trial NCT02363491 study?
This clinical trial studies the following conditions: Myelodysplastic Syndrome.
What interventions are being tested in trial NCT02363491?
The interventions under investigation include: OPN-305 (DRUG).
Who is sponsoring clinical trial NCT02363491?
This trial is sponsored by Opsona Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02363491 being conducted?
This trial has 4 study locations across Florida, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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