Follow up Protocol to the Phase I/II Study of OPN-305 in... | NCT03337451

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

NCT03337451

Sponsor

Opsona Therapeutics Ltd.

Status

Completed

Last Update Posted

Jan 28, 2019Actual

Enrollment

14Actual

Phase

Phase 1Phase 2

Conditions

Myelodysplastic Syndrome

Interventions

OPN-305

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official Title

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)

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 27, 2018Actual

Primary Completion Date

Jan 10, 2019Actual

Completion Date

Jan 10, 2019Actual

First Submitted Date

Oct 18, 2017

First Submission Date that Met QC Criteria

Nov 6, 2017

First Posted Date

Nov 9, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Jan 24, 2019

Certification/Extension First Submitted that Passed QC Review

Jan 24, 2019

Certification/Extension First Posted Date

Jan 28, 2019Actual

Last Update Submitted Date

Jan 24, 2019

Last Update Posted Date

Jan 28, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Opsona Therapeutics Ltd.INDUSTRY

Collaborators

Name	Class
M.D. Anderson Cancer Center	OTHER
Montefiore Medical Center	OTHER
H. Lee Moffitt Cancer Center and Research Institute	OTHER
New York Presbyterian Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OPN-305	Experimental		Drug: OPN-305

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OPN-305	Drug	Patients will receive study drug every 4 weeks	OPN-305

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Houston	Texas	77030	United States

Type	Date	Date Unknown
Release	Jul 19, 2021
Reset	Aug 16, 2021

Submission Tracking

Estimated Results First Submitted Date

Jul 19, 2021

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 19, 2021			Aug 16, 2021

Condition Browse Module

MeSH Terms

ID	Term
D009190	Myelodysplastic Syndromes

Ancestor Terms

ID	Term
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C585159	tomaralimab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided