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OSCAR II STUDY - The ONCObind CTC Removal Study

ConditionsPancreatic Ductal Adenocarcinoma (mPDAC)Metastatic Colorectal Carcinoma (mCRC)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorExThera Medical Corporation

About this trial

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 site's 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 who experienced disease progression or not tolerating fluoropyrimidine-, oxaliplatin- and irinotecan- based regimens or prior treatment with gemcitabine and nab-paclitaxel or are not candidates for chemotherapy or mCRC patients who experienced disease progression on 5-fluorouracil (5-FU), capecitabine, oxaliplatin and irinotecan as FOLFIRI and/or FOLFOX and/or XELOX and/or XELIR and/or FOLFOXIRI/FOLFIRINOX or who are not candidates for chemotherapy with at least 5 cells/mL CTCs in peripheral blood and/or portal vein.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients ≥ 18 years of age with

mPDAC cohort: Metastatic pancreatic ductal cancer who experienced disease progression or not tolerating fluoropyrimidine-, oxaliplatin- and irinotecan- based regimens or prior treatment with gemcitabine and nab-paclitaxel or are not a candidate for chemotherapy

mCRC Cohort : Metastatic CRC who experienced disease progression on 5-fluorouracil (5-FU), capecitabine, oxaliplatin and irinotecan as FOLFIRI and/or FOLFOX and/or XELOX and/or XELIRI and/or FOLFOXIRI/FOLFIRINOX or who are not candidates for chemotherapy.

Patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) scores of 2 or less.

Disqualifiers

Pregnant or breast feeding

Patients who cannot tolerate the placement of a tunneled catheter for vascular access to enable extracorporeal treatment.

Patients with a history of heparin induced thrombocytopenia (HIT).

Patients with known allergy to heparin sodium.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ONCObind (Onco-Seraph) 100 Filter

    Device

    The ONCObind Microbind® Affinity Blood Filter ( ONCObind) manufactured by ExThera Medical Corporation in Martinez, CA. The ONCObind filter has been designed and manufactured to reduce residual risks as much as possible to ensure safe usage. Literature search results concluded that heparin-coated medical devices are safe and decrease platelet adhesion without affecting the adsorption of major adhesive proteins. Literature search yielded over 60 publications and 500 treated patients with Seraph platform technology for pathogen removals without and significant safety concern. The achieved results from the above-mentioned testing and studies support the performance and safety of ONCObind consistent with the intended use. ExThera Medical concludes that the known and potential benefits of ONCObind, when used to treat patients with PDAC, outweigh the known and potential risks when used according to the intended use.

  • Matched Controls

    Other intervention

    Study patients will be assigned to receive procedure with the investigational device (ONCObind) and will be matched with 60 site specific controls, 30 PDAC and 30 CRC.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: ONCObind (Onco-Seraph) 100 Filter is a single useExperimental treatment 1 intervention
Group B: Matched ControlsOther 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of procedure-emergent adverse events (AEs) graded using the NCI CTCAE Version 5.0

Incidence of procedure-emergent adverse events (AEs) graded using the NCI CTCAE Version 5.0

Time frame
210 days
2

Incidence of procedure-emergent serious adverse events (SAEs) graded using the NCI CTCAE Version 5.0

Incidence of procedure-emergent serious adverse events (SAEs) graded using the NCI CTCAE Version 5.0

Time frame
210 days
3

Evaluation of Survival

Survival follow-up will be assessed after enrollment (vital status check)

Time frame
60, 120, 180 and 210 days
4

Change in CTC Concentration

The change in CTC concentration from baseline to the end of the induction series as well as 180 days after baseline of Extracorporeal Procedure (ECPs) with ONCObind

Time frame
180 days

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ExThera Medical Corporation

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: