OSPREY is a Post-market, Global, Multicentre, Observational, Prospective Registry. (OSPREY)

• ClinicalTrials.gov Identifier: NCT04493632
• Recruitment Status: Recruiting
• First Posted: July 30, 2020
• Last Update Posted: November 9, 2022
• Sponsor: OncoSil Medical Limited
• Information provided by (Responsible Party): OncoSil Medical Limited

Tracking Information

• First Submitted Date: July 21, 2020
• First Posted Date: July 30, 2020
• Last Update Posted Date: November 9, 2022
• Actual Study Start Date: April 12, 2022
• Estimated Primary Completion Date: November 1, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 27, 2020)

• Safety and tolerability of Device [ Time Frame: Followed to death or to 24-months post the date of the last enrolled patient implanted with OncoSil™ ]
  The analysis for safety within the real-world setting will be performed. The safety of OncoSil™ is defined by the Adverse Event profile. All safety summaries will be produced for the Intention-To-Treat (ITT) population. Adverse events will be coded using Medical Dictionary for Regulatory Activities (MedDRA). All Adverse Events recorded during the Registry will be listed. Summary tables will be produced for Treatment Emergent Adverse Events (TEAEs). The number and percentage of patients with device-related Adverse Events by system organ class (SOC) and preferred term will be tabulated. Similar summaries will be produced by severity of event (both mild, moderate or severe, CTCAE grade 1-4) and drug and/or device relationship. In addition, summary tables will be produced for serious TEAEs and TEAEs associated with special interest acute/late radiation effects and or withdrawal.
• Device Implantation Performance [ Time Frame: 7 years ]
  Safety of the implantation of OncoSil™ within the target tumour will be measured by means of procedure-related Adverse Events. An assessment of the utility of OncoSil™ Implantation will be made and listed appropriately.
• Overall Survival [ Time Frame: Followed to death or to 24-months post the date of the last enrolled patient implanted with OncoSil™ ]
  Overall survival (OS) is defined as the time from enrolment to the date of death from any cause. Patients who are alive or permanently lost to follow-up at the cut-off date for the analysis will be censored at the last date the patient was known to be alive. Overall Survival (OS) will be analysed at the interim analysis and once all 500 OncoSil™ implanted patients have been followed to death or to 24-months post the date of the last enrolled/treated patient.
• tumour response as demonstrated by target tumour response demonstrated by RECIST 1.1 [ Time Frame: 7 years ]
  Target (implanted) tumor response (local and distant)
• Resection Rates [ Time Frame: 7 years ]
  Surgical resection rates and outcome

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: OSPREY is a Post-market, Global, Multicentre, Observational, Prospective Registry.
• Official Title: OncoSil Pancreatic Cancer Post-marketing Clinical REgistrY (OSPREY)

Brief Summary

The OSPREY Patient Registry has been developed to collect and assess the performance and safety of the OncoSil™ device when used within the approved indication of unresectable, locally advanced pancreatic cancer, in combination with gemcitabine-based chemotherapy, within a real-world observational registry.

The Registry data will provide both complementary and contemporary information to the existing clinical data across various countries and will form part of the post-market clinical follow-up activities for OncoSil™. Therefore, the Registry will be implemented only in countries with regulatory (commercial) approval for the OncoSil™ device.

Detailed Description

OSPREY is a post-market, global, multicentre, observational, prospective registry in which data is recorded from patients who undergo OncoSil™ device implantation.

Countries intended for initial commercial distribution include Australia, Belgium, France, Germany, Italy, Singapore, Spain, & the United Kingdom.

Only patients who are intended to undergo treatment with the OncoSil™ device in the commercial (sales) setting will participate in this Registry.

Every patient who is prescribed OncoSil™ in the commercial setting will be approached by the Treating Physician to consent to participate in the OSPREY Patient Registry.

Patients who choose not to consent to participate in the OSPREY Patient Registry will not be excluded from being treated with the OncoSil™ device.

Five hundred patients (implanted with OncoSil™) will be recruited into the OSPREY Patient Registry. It is anticipated recruitment will be over a five-year period, subject to the rate of commercial adoption of the OncoSil™ device in the market.

To adequately collect data relating to the performance and safety of the OncoSil™ device, data will be collected from patients over a prescribed 12-month period from enrolment, the cohort is then followed to death or to 24-months post the date of the last enrolled patient implanted with OncoSil™.

Therefore, the Registry is expected to run for a seven-year period. Relevant observational data will be collected via medical record review.

• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 24 Months
• Biospecimen: Not Provided
• Sampling Method: Probability Sample

Study Population

Every patient who is intended to undergo implantation of the OncoSil™ device when used within the approved indication of unresectable, locally advanced pancreatic cancer, in combination with gemcitabine-based chemotherapy, in the commercial (sales) setting will be approached by the Treating Physician to consent to participate in the OSPREY Patient Registry.

Patients who choose not to consent to participate in the OSPREY Patient Registry will not be excluded from being treated with the OncoSil™ device.

.

Condition

• Pancreatic Neoplasm
• Digestive System Neoplasm
• Neoplasms by Site
• Neoplasms
• Endocrine Gland Neoplasm
• Digestive System Disease
• Pancreatic Diseases
• Endocrine System Diseases

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 27, 2020): 500
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 1, 2027
• Estimated Primary Completion Date: November 1, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Patients with confirmed unresectable locally advanced pancreatic cancer (LAPC).
2. Patients who undergo OncoSil™ implantation at an eligible treatment facility.
3. Patients who have completed and signed the Patient Informed Consent Form (PICF) for the OSPREY Patient Registry.
4. Pancreatic target tumour recommended size of <7 cm (longest diameter) and <110 cc volume.
5. A clinically acceptable ECOG performance status.
6. Patients ≥ 18 years of age at screening.
7. To commence gemcitabine-based chemotherapy, (per Standard-of-Care are according to the approved prescribing schedule) post Registry enrolment.
8. Adequate biochemical tests, coagulation profile, haematological, renal, and hepatic function as determined by the Treating Physician.

Exclusion Criteria:

1. Patient Informed Consent Form (PICF) has not been completed and signed for the OSPREY Patient Registry.
2. Patients treated with OncoSil™ within an approved interventional clinical study (company or investigator-sponsored).
3. Evidence of distant metastases based on review of baseline CT scan.
4. More than one primary lesion.

5. In the opinion of the Treating Physician, EUS-directed implantation posing undue patient risk. This includes:

   • where previous EUS-FNA was considered technically too difficult to perform;
   • imaging demonstrates multiple collateral vessels surrounding or adjacent to the target tumour within the pancreas;
   • presence (or significant risk) of varices near to the target tumour.
6. Evidence of radiographic invasion into stomach or duodenum (if not certain, confirmation must be obtained prior to enrolment).
7. In the setting of recent, clinically significant pancreatitis, implantation is not recommended.
8. Pregnant or intending to commence a pregnancy within 12-months of the intended date of implantation or breastfeeding.
9. Patients who have a known history of hypersensitivity to silicon or phosphorous, or any of the OncoSil™ components

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Tom Maher; +44 750 4658585; tom.maher@oncosil.com

Contact: Nicole G Gaddi, B.Sc Nursing; + 61 (0)428 946 588; nicole.gaddi@oncosil.com

• Listed Location Countries: Spain, United Kingdom

Administrative Information

• NCT Number: NCT04493632
• Other Study ID Numbers: OSPREY01
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: OncoSil Medical Limited
• Original Responsible Party: Same as current
• Current Study Sponsor: OncoSil Medical Limited
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Paul J Ross, MRCP, MBBS; Guy's and St Thomas' NHS Foundation Trust, London, UK

• PRS Account: OncoSil Medical Limited
• Verification Date: November 2022