Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06655142
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-19
Brief Title:
OSCAR II STUDY - The ONCObind CTC Removal Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Matched Control Feasibility Study to Determine the Capacity of the Onco-Seraph 100 Microbind Affinity Blood Filter ONCObind Procedure to Remove Circulating Tumor Cells From the Blood in Patients With Either Metastatic Pancreatic Adenocarcinoma or Metastatic Colorectal Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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 dual cohort Open Label Feasibility trial to evaluate the initial safety and signal of efficacy of a novel extracorporeal blood purification EBP procedure in either mPDAC or mCRC 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 mPDAC and mCRC Adults 18 years old and older ECOG PS of equal or less than 2 with a diagnosis of either mPDAC as defined histologically microscopically as a pancreatobiliary type adenocarcinoma with at least 5 cellsmL CTCs in peripheral blood andor portal vein or mCRC with at least 5 cellsmL CTCs in peripheral blood
Detailed Description:
Study Intervention All study patients will be assigned to receive procedure with the investigational device ONCObind Study Duration Our target enrollment is 30 patients with mPDAC and 30 patients with mCRC The study will last for up to two years Interim analyses will determine early stopping for safety This is detailed in Section 22 Data Safety Monitoring Board DSMB Furthermore as the safety and effectiveness of the experimental use of the ONCObind device for treatment of patients with mPDAC andor mCRC is unknown patients will be followed for up to 5 years to inform oncological outcomes
Procedure Setting Extracorporeal blood purification utilizing ONCObind 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 ONCObind 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 the subject will be monitored for up to 4 hours post procedure per PI discretion
Procedure Duration for ONCObind A sufficient blood flow rate and exposure of patients blood to the ONCObind 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 20 hours for an oncology patient an average of 200mLmin translates to a procedure time of 8 hours for blood stream infection or 35 hrs for oncology patient
OSCAR I 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
OSCAR II 2nd Stage Study Procedure s will occur up to 3-5 times for the first week followed by 1-3treatments through week 4 for a total of up to 8 treatments over the first 28 days of study participation Study treatments will continue every 4 weeks - 1 week from week 5 through week 26
Study Procedures will be held if subjects are hemodynamically unstable and unable to tolerate extracorporeal procedure defined as MAP65 and or 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 visits and as part of routine standard of care for mPDAC or mCRC All subjects enrolled in this study will undergo clinical efficacy safety and laboratory assessments Blood and clinical data collection samples will be obtained at Screening Induction Phase and Procedure Follow up Phase in accordance to Schedule of Events Demographic and baseline clinical parameters will be recorded at the time of enrollment Pertinent clinical parameters will be recorded in accordance to Schedule of Events Outcomes data will be recorded on in accordance to Schedule of Events Subject status will be in accordance to Schedule of Events to include adverse event evaluation and a targeted medication review Survival follow-up will be assessed at 60 120 180 and 210 days after enrollment andor at the time of death
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 in each mPDAC and mCRC cohort to evaluate for safety and efficacy prior to completion of enrollment n30 for each cohort as detailed in 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
Procedure Setting Extracorporeal blood purification utilizing ONCObind 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 ONCObind 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 the subject will be monitored for up to 4 hours post procedure per PI discretion
Procedure Duration for ONCObind A sufficient blood flow rate and exposure of patients blood to the ONCObind 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 20 hours for an oncology patient an average of 200mLmin translates to a procedure time of 8 hours for blood stream infection or 35 hrs for oncology patient
OSCAR I 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
OSCAR II 2nd Stage Study Procedure s will occur up to 3-5 times for the first week followed by 1-3treatments through week 4 for a total of up to 8 treatments over the first 28 days of study participation Study treatments will continue every 4 weeks - 1 week from week 5 through week 26
Study Procedures will be held if subjects are hemodynamically unstable and unable to tolerate extracorporeal procedure defined as MAP65 and or 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 visits and as part of routine standard of care for mPDAC or mCRC All subjects enrolled in this study will undergo clinical efficacy safety and laboratory assessments Blood and clinical data collection samples will be obtained at Screening Induction Phase and Procedure Follow up Phase in accordance to Schedule of Events Demographic and baseline clinical parameters will be recorded at the time of enrollment Pertinent clinical parameters will be recorded in accordance to Schedule of Events Outcomes data will be recorded on in accordance to Schedule of Events Subject status will be in accordance to Schedule of Events to include adverse event evaluation and a targeted medication review Survival follow-up will be assessed at 60 120 180 and 210 days after enrollment andor at the time of death
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 in each mPDAC and mCRC cohort to evaluate for safety and efficacy prior to completion of enrollment n30 for each cohort as detailed in 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None