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COMPLETED Phase 1

A Phase I/II Study of OPN-305 in Second-line Lower Risk Myelodysplastic Syndrome

NCT02363491 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 96 participants
Start Date 2015-01
Est. Completion 2018-12
Phase Phase 1

Sponsor

Opsona Therapeutics

1 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Opsona Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02363491 reports 4 study locations spanning 3 distinct geographic areas — top geographies include New York, Florida, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02363491?

The interventions under investigation include: OPN-305 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02363491?

This trial is sponsored by Opsona Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial