Follow up Protocol to the Phase I/II Study of OPN-305 in Second-line or Third-line Lower Lower Risk Myelodysplastic Syndrome
Follow up Protocol to the Open Label Phase I/II Study OPN-305-106: A Prospective, Open Label Phase I/II Study to Assess the Safety and Efficacy of Cycles of Intravenously Infused Doses of OPN-305 in Second-line and Third-line Lower (Low and Intermediate-1) Risk Myelodysplastic Syndrome (MDS)
1 other identifier
interventional
14
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2017
CompletedFirst Posted
Study publicly available on registry
November 9, 2017
CompletedStudy Start
First participant enrolled
February 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2019
CompletedJanuary 28, 2019
January 1, 2019
11 months
October 18, 2017
January 24, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence and types of Serious Adverse events
monthly through study completion, an average of 18 months
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
monthly through study completion, an average of 18 months
Study Arms (1)
OPN-305
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Opsona Therapeutics Ltd.lead
- M.D. Anderson Cancer Centercollaborator
- Montefiore Medical Centercollaborator
- H. Lee Moffitt Cancer Center and Research Institutecollaborator
- New York Presbyterian Hospitalcollaborator
Study Sites (1)
Research Site
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2017
First Posted
November 9, 2017
Study Start
February 27, 2018
Primary Completion
January 10, 2019
Study Completion
January 10, 2019
Last Updated
January 28, 2019
Record last verified: 2019-01