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Follow up Protocol to the Phase I/II Study of OPN-305 in Second-line or Third-line Lower Lower Risk Myelodysplastic Syndrome

NCT03337451 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2019-01-28

No results posted yet for this study

Summary

This protocol is a follow-up for patients receiving continuation of OPN-305 monotherapy treatment or combination treatment with azacitidine after completion of the dose confirming, dose expansion and HMA naïve parts of the main study OPN-305-106.

Conditions

Interventions

DRUG

OPN-305

Patients will receive study drug every 4 weeks

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-27
Primary Completion
2019-01-10
Completion
2019-01-10
FDA Drug
Yes

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 NCT03337451 on ClinicalTrials.gov