Ignite Creation Date:
2024-07-17 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06481397
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2024-06-24
Brief Title:
OSCAR I STUDY - The ONCObind CTC Removal Study
Sponsor:
ExThera Medical Corporation
Organization:
ExThera Medical Corporation
Study Overview
Official Title:
Prospective Single-Arm Feasibility Study to Determine the Capacity of the Onco-Seraph 100 Microbind Affinity Blood Filter Onco-Seraph 100 to Remove Circulating Tumor Cells From the Blood of Patients With Metastatic Pancreatic Ductal Adenocarcinoma PDAC
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a Prospective Single Arm Open Label Feasibility trial to evaluate the initial safety and signal of efficacy of a novel extracorporeal blood purification EBP procedure in metastatic PDAC refractory to systemic therapy Site selection will be dependent upon the sites familiarity with extracorporeal blood purification platforms as well as the diagnosis and management of PDAC Adults 18 years old and older ECOG PS of equal or less than 2 with a diagnosis of PDAC as defined histologically microscopically as a pancreatobiliary type adenocarcinoma with at least 5 UmL CTCs in peripheral blood andor portal vein
Detailed Description:
Study Intervention All study patients will be assigned to receive treatment with the investigational device Onco-Seraph 100
Study Duration Our target enrollment is 30 patients with PDAC The study will last for up two years Interim analyses will determine early stopping for safety This is detailed in Section 23 Data Safety Monitoring Board DSMB Furthermore as the safety and effectiveness of the experimental use of the ONCO Seraph 100 Microbind Affinity Blood Filter for treatment of patients with PDAC is unknown patients will be followed for up to 5 years to inform oncological outcomes
Procedure Setting Extracorporeal blood purification utilizing Seraph can be performed either on an outpatient or an in-patient basis as HDCRRT procedure is performed routinely in both settings Whether the procedure will be performed in a setting of an outpatient or in-patient setting would mainly depend on the personalized approach that the Site Investigator choses related to individual patient enrolled in the study Location of the Seraph treatment will be recorded and data analysis will include consideration of the setting as it relates to study endpoints If the Study Procedure is implemented in an outpatient setting subject will be monitored for additional 4 hours
Procedure Duration for Onco-Seraph 100 A sufficient blood flow rate and exposure of patients blood to the Onco-Seraph 100 adsorption media was initially established based on the experience in implementing procedure in patients with blood stream infections However target procedure duration is further optimized based on data collected in EU oncology patients as listed below
The average procedure duration and blood flow rates targeted in patients with blood stream infections or oncology are as follows
At an average blood flow of 350mLmin this would translate to approximately 5 hours of procedure time for patients with blood stream infection or 20hrs for oncology patient an average of 200mLmin translates to a procedure time of 8 hours for blood stream infection or 35hrs for oncology patient
1st stage Study Procedure will occur only once followed by weekly follow up visits through day 28 followed by monthly follow up through Day 60
2nd stage Study Procedures will occur up to 3 times for the first week followed by once weekly for the following 3 weeks for a total of up to 6 treatments over the first 28 days of study participation
Study Procedures will be held if subjects are hemodynamically unstable and unable to tolerate extracorporeal procedure defined as MAP65 andor sustained hypotension at enrollment as defined by two readings with systolic blood pressure SBP measurements below 100 mmHg or diastolic blood pressure DBP measurements below 50 mmHg The measurements must be performed thirty minutes from one another and the Subject must be resting for at least 5 minutes prior to obtaining each measurement If the first reading includes a SBP greater than 100 mmHg and a DBP greater than 50 mmHg the second reading does not need to be taken
Subjects will be assessed per study visit and as part of routine standard of care for PDAC All subjects enrolled in this study will undergo clinical efficacy safety and laboratory assessments Blood urine and respiratory samples will be obtained at baseline Day 1 Day 4 Day 7 14 21 and Day 28 Demographic and baseline clinical parameters will be recorded at the time of enrollment Pertinent clinical parameters will be recorded on days 1 3 5 7 14 21 and once on day 28 Outcomes data will be recorded on day 28 and at the time of hospital discharge or death Subject status will be assessed at 1 3 5 7 14 21 28 or30 and 60 days to include adverse event evaluation and a targeted medication review Survival status will be assessed 30 and 60 days after enrollment
Patients will receive standard of care follow-up for up to 5 years and this data collected will be made available for FDA review
A subset of the protocol team will review Grade 3 and 4 adverse event or serious adverse event AE SAE data every 2 weeks If there is a pattern of unexpected AEs that is out of proportion to the current understanding of the natural history of the disease the DSMB will be asked to review un-blinded safety data in an ad hoc meeting If an ad hoc meeting of the DSMB is convened to review a serious device-related adverse event enrollment will be halted pending the DSMB review to ensure subject safety in the trial The DSMB will review the event to ensure subject safety After the review the DSMB will determine if enrollment may resume
The DSMB will conduct an interim analysis after the enrollment of 10 subjects to evaluate for safety and efficacy prior to completion of enrollment n30 as detailed in Section 23 Data Safety Monitoring Board DSMB and will be available for ad hoc reviews for safety concerns as described above As stated above enrollment will be halted pending the convening of an ad hoc DSMB meeting to review a serious device-related adverse event
The DSMB will review the event to ensure subject safety in the trial The DSMB will determine if enrollment may resume The DSMB may recommend temporary or permanent cessation of enrollment based on their safety reviews
As part of the initial PK study DSMB will also review safety data after the first 2 and 5 subjects consented and treated If there are significant safety concerns after DSMB review the sponsor will immediately pause the trial and communicate the information with the FDA
The safety data of the first 5 subjects will be reported to FDA for review Study expansion will be allowed via FDA pre-approved IDE supplement prior to commencing enrollment of the remaining subjects
Study Duration Our target enrollment is 30 patients with PDAC The study will last for up two years Interim analyses will determine early stopping for safety This is detailed in Section 23 Data Safety Monitoring Board DSMB Furthermore as the safety and effectiveness of the experimental use of the ONCO Seraph 100 Microbind Affinity Blood Filter for treatment of patients with PDAC is unknown patients will be followed for up to 5 years to inform oncological outcomes
Procedure Setting Extracorporeal blood purification utilizing Seraph can be performed either on an outpatient or an in-patient basis as HDCRRT procedure is performed routinely in both settings Whether the procedure will be performed in a setting of an outpatient or in-patient setting would mainly depend on the personalized approach that the Site Investigator choses related to individual patient enrolled in the study Location of the Seraph treatment will be recorded and data analysis will include consideration of the setting as it relates to study endpoints If the Study Procedure is implemented in an outpatient setting subject will be monitored for additional 4 hours
Procedure Duration for Onco-Seraph 100 A sufficient blood flow rate and exposure of patients blood to the Onco-Seraph 100 adsorption media was initially established based on the experience in implementing procedure in patients with blood stream infections However target procedure duration is further optimized based on data collected in EU oncology patients as listed below
The average procedure duration and blood flow rates targeted in patients with blood stream infections or oncology are as follows
At an average blood flow of 350mLmin this would translate to approximately 5 hours of procedure time for patients with blood stream infection or 20hrs for oncology patient an average of 200mLmin translates to a procedure time of 8 hours for blood stream infection or 35hrs for oncology patient
1st stage Study Procedure will occur only once followed by weekly follow up visits through day 28 followed by monthly follow up through Day 60
2nd stage Study Procedures will occur up to 3 times for the first week followed by once weekly for the following 3 weeks for a total of up to 6 treatments over the first 28 days of study participation
Study Procedures will be held if subjects are hemodynamically unstable and unable to tolerate extracorporeal procedure defined as MAP65 andor sustained hypotension at enrollment as defined by two readings with systolic blood pressure SBP measurements below 100 mmHg or diastolic blood pressure DBP measurements below 50 mmHg The measurements must be performed thirty minutes from one another and the Subject must be resting for at least 5 minutes prior to obtaining each measurement If the first reading includes a SBP greater than 100 mmHg and a DBP greater than 50 mmHg the second reading does not need to be taken
Subjects will be assessed per study visit and as part of routine standard of care for PDAC All subjects enrolled in this study will undergo clinical efficacy safety and laboratory assessments Blood urine and respiratory samples will be obtained at baseline Day 1 Day 4 Day 7 14 21 and Day 28 Demographic and baseline clinical parameters will be recorded at the time of enrollment Pertinent clinical parameters will be recorded on days 1 3 5 7 14 21 and once on day 28 Outcomes data will be recorded on day 28 and at the time of hospital discharge or death Subject status will be assessed at 1 3 5 7 14 21 28 or30 and 60 days to include adverse event evaluation and a targeted medication review Survival status will be assessed 30 and 60 days after enrollment
Patients will receive standard of care follow-up for up to 5 years and this data collected will be made available for FDA review
A subset of the protocol team will review Grade 3 and 4 adverse event or serious adverse event AE SAE data every 2 weeks If there is a pattern of unexpected AEs that is out of proportion to the current understanding of the natural history of the disease the DSMB will be asked to review un-blinded safety data in an ad hoc meeting If an ad hoc meeting of the DSMB is convened to review a serious device-related adverse event enrollment will be halted pending the DSMB review to ensure subject safety in the trial The DSMB will review the event to ensure subject safety After the review the DSMB will determine if enrollment may resume
The DSMB will conduct an interim analysis after the enrollment of 10 subjects to evaluate for safety and efficacy prior to completion of enrollment n30 as detailed in Section 23 Data Safety Monitoring Board DSMB and will be available for ad hoc reviews for safety concerns as described above As stated above enrollment will be halted pending the convening of an ad hoc DSMB meeting to review a serious device-related adverse event
The DSMB will review the event to ensure subject safety in the trial The DSMB will determine if enrollment may resume The DSMB may recommend temporary or permanent cessation of enrollment based on their safety reviews
As part of the initial PK study DSMB will also review safety data after the first 2 and 5 subjects consented and treated If there are significant safety concerns after DSMB review the sponsor will immediately pause the trial and communicate the information with the FDA
The safety data of the first 5 subjects will be reported to FDA for review Study expansion will be allowed via FDA pre-approved IDE supplement prior to commencing enrollment of the remaining subjects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None