MedTrace Logo

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

NCT02363491 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2019-01-28

No results posted yet for this 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

Interventions

DRUG

OPN-305

For the dose confirming part of the study, patients will receive a starting dose of 5 mg/kg OPN-305.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • Montefiore Medical Center

    collaborator OTHER

  • H. Lee Moffitt Cancer Center and Research Institute

    collaborator OTHER

  • New York Presbyterian Hospital

    collaborator OTHER

  • Opsona Therapeutics Ltd.

    lead INDUSTRY

Principal Investigators

  • Guillermo Garcia Manero, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02363491 on ClinicalTrials.gov