Follow up Protocol to the Phase I/II Study of OPN-305 in Second-line or Third-line Lower Lower Risk Myelodysplastic Syndrome
NCT ID: NCT03337451
Last Updated: 2019-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
14 participants
INTERVENTIONAL
2018-02-27
2019-01-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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OPN-305
OPN-305
Patients will receive study drug every 4 weeks
Interventions
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OPN-305
Patients will receive study drug every 4 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Montefiore Medical Center
OTHER
H. Lee Moffitt Cancer Center and Research Institute
OTHER
New York Presbyterian Hospital
OTHER
Opsona Therapeutics Ltd.
INDUSTRY
Responsible Party
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Locations
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Research Site
Houston, Texas, United States
Countries
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Other Identifiers
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OPN-305-110
Identifier Type: -
Identifier Source: org_study_id
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