OSCAR I STUDY - The ONCObind CTC Removal Study

Korábbi kezelés

• Hemodynamic instability and inability to tolerate extracorporeal procedure (defined as MAP<65 despite fluids and vasopressors 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.
• Participation in an investigational drug study or history of receiving any investigational treatment within 14 days prior to initiation of treatment on this study.
• Concurrent participation in any interventional clinical trial or has been previously entered in this trial.

Más betegség

• Patients with a history of heparin induced thrombocytopenia (HIT).
• Uncontrolled hypertension despite optimal management (systolic blood pressure >150 mmHg or diastolic pressure > 90mmHg).
• Ongoing uncontrolled, serious infection.
• Renal failure requiring dialysis.

Laborértékek

• Patients with known allergy to heparin sodium.
• High risk of bleeding (platelet count <50mm3 or International Normalized Ratio (INR) >1.5)

Egyéb

• Pregnant or breast feeding
• Patients who cannot tolerate the placement of a dual lumen vascular access to enable extracorporeal treatment.
• Patients with a life expectancy of less than 30 days.
• Pregnant and nursing women.
• The Patient is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator.
• Unable to obtain informed consent from either patient or legally authorized representative (LAR)
• Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.

• Patients ≥ 18 years of age with metastatic pancreatic ductal carcinoma who experienced disease progression or not tolerating fluoropyrimidine-, oxaliplatin- and irinotecan- based regimens or prior treatment with gemcitabine and nab-paclitaxel.
• Patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) scores of 2 or less.
• Patient or legally authorized representative is willing and able to understand and provide a signed informed consent that fulfills the relevant IRB or Independent Ethics Committee (IEC) guidelines.
• Patients with a CTC concentration of at least 5 cells/mL
• Must be willing to provide blood samples for prospective tumor molecular profiling and exploratory analyses.
• Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
• Female patients must be of non-childbearing potential or using a medically acceptable contraceptive regimen. Effective contraception includes surgical sterilization (e.g., vasectomy, tubal ligation), two forms of barrier methods (e.g., condom, diaphragm) used with spermicide, IUDs.
• Female patients must have a negative serum pregnancy test at Screening, and negative urine pregnancy test at baseline prior to dosing.
• Male patients must be surgically sterile or using a medically acceptable contraceptive regimen. Effective contraception includes surgical sterilization (e.g., vasectomy, tubal ligation), two forms of barrier methods (e.g., condom, diaphragm) used with spermicide, IUDs.