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CompletedNCT03337451Updated Jan 28, 2019

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

A Phase 1/2 interventional study of OPN-305 in Myelodysplastic Syndrome, sponsored by Opsona Therapeutics Ltd.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-28.

Sponsored by Opsona Therapeutics Ltd. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Myelodysplastic Syndrome
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Completion of the OPN-305-106 study
  • Principal Investigator adjudicated efficacy response defined as either transfusion independence", "stable disease", "minor HI-E response" or "major HI-E response" and in the opinion of the Principal Investigator the patient may benefit from continued treatment with OPN-305 monotherapy or combination treatment with azacitidine.
  • Provide written informed consent for the follow up protocol.

Exclusion criteria

Exclusion Criteria:

  • Refusal to provide written informed consent
  • Withdrawal from the OPN-305-106 study prior to the final EOT visit
  • Plan to be included into another interventional investigational study.
  • Progression of disease
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    OPN-305

    Drug: OPN-305

Interventions

  • DrugOPN-305

    Patients will receive study drug every 4 weeks

05

What researchers measure

Primary outcomes

  1. Incidence and types of Serious Adverse events

    Time frame: monthly through study completion, an average of 18 months

  2. monitor ongoing efficacy responses

    To monitor ongoing efficacy responses defined as "transfusion independence". Transfusion independence is defined as 56 consecutive days where no RBC transfusions are given

    Time frame: monthly through study completion, an average of 18 months

06

Study locations

1 site
  • Research Site
    Houston, Texas 77030, United States
07

Registry details

Key details

Study ID
NCT03337451
Lead sponsor
Opsona Therapeutics Ltd.
Collaborators
M.D. Anderson Cancer Center, Montefiore Medical Center, H. Lee Moffitt Cancer Center and Research Institute, New York Presbyterian Hospital
Responsible party
Sponsor
First posted
Nov 9, 2017
Start date
Feb 27, 2018
Primary completion
Jan 10, 2019
Completion
Jan 10, 2019
Last update
Jan 28, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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