A Pilot Study of OncoSil™ Given to Patients With Pancreatic Cancer Treated With FOLFIRINOX or Gemcitabine+Abraxane

NCT03003078 | Completed DMC

• 1 other identifier: ONC01P03
• Study Type: interventional
• Target: 50
• Locations: 3 countries
• Sites: 12

Brief Summary

To evaluate the safety of OncoSil™ in a patient population undergoing standard chemotherapy treatment for pancreatic cancer. This study has been designed to satisfy regulatory requirements. The clinical investigation will be conducted at approximately 15 sites in Australia, the United Kingdom and Europe (Belgium) involving 40 patients.

Conditions

Unresectable Locally Advanced Pancreatic Carcinoma

Keywords

Pancreatic cancer; Pancreas; metastases; pancreatic tumour; unresectable; locally advanced; implantable; radiographic; device; Phosphorous-32; OncoSil™; brachytherapy; FOLFIRINOX; gemcitabine; nab-paclitaxel; Abraxane

Outcome Measures

Primary Outcomes (1)

• Safety / Tolerability of Device according to CTCAE V4.0

  as determined by the number of treatment emergent adverse events (TEAEs) evaluated

  Collected from the of signed informed consent until patient death or 104 weeks post last patient enrollment date, whichever is sooner

Secondary Outcomes (6)

• Local Progression free survival within the pancreas

  Assessed from Baseline through to first confirmed CT documentation of local progression within the pancreas, an average of 12 months.

• Progression free survival - entire body

  Assessed from Baseline through to EOS visit - an average of 12 months.

• Overall survival

  104 weeks post last patient first study visit

• Body weight

  Assessed from Baseline through to EOS visit, an average of 12 months.

• Impaired function

  Frame: Measured at each study visit for the duration of the study, an average of 12 months

Other Outcomes (2)

• tumour response

  Baseline measure from screening period, compared to Week 8 CT result, and then to 8 weekly CT results until local progression is determined, an average of 12 months.

• tumour response

  As assessed at Week 12 study visit compared to Baseline assessment completed during screening period

Study Arms (1)

OncoSil™ plus SOC Chemotherapy

OTHER

OncoSil™ implanted with concurrent Standard of care Chemotherapy - either FOLFIRINOX or gemcitabine + Abraxane.

Device: OncoSil™

Interventions

OncoSil™ DEVICE

The implantation of OncoSil™

OncoSil™ plus SOC Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically proven adenocarcinoma of the pancreas.
• Unresectable locally advanced pancreatic carcinoma. Patients with technically resectable tumours (T1-T3) will also be eligible, if they are deemed unresectable due to medical comorbidities or refusal of surgery.
• Pancreatic target tumour diameter of ≥ 2.0 cm (shortest axis) to ≤ 6.0 cm (longest axis), as qualified by the central reading centre.
• An ECOG Performance Status of 0 to 1 and Karnofsky Performance Status of 80 - 100.
• Study participants ≥ 18 years of age at screening.
• To commence first-line standard FOLFIRINOX or gemcitabine+nab-paclitaxel chemotherapy (per standard of care according to the approved prescribing schedule), within 14 days post enrolment, with OncoSil™ implantation to occur during the fourth (4th) week of the first chemotherapy cycle.
• Provide signed Informed Consent.
• Willing and able to complete study procedures within the study timelines.
• Adequate renal function: serum creatinine less than 1.5 x upper limit of normal (ULN).
• Adequate liver function: serum liver transaminases ≤ 3 × ULN and serum bilirubin
• ≤ 1.5 × ULN\*.
• \*For study participants with recent biliary obstruction treated by drainage (e.g. stent), serum bilirubin of \> 1.5 x ULN will be accepted for study entry provided that serial levels demonstrate clear improvement. In addition, chemotherapy should not be commenced until serum bilirubin is ≤ 1.5 × ULN.
• Adequate bone marrow function: white blood cells (WBCs) ≥ 3,000/mm3, absolute neutrophil count (ANC) ≥ 1,500/mm3, haemoglobin ≥ 9 g/dL, and platelets ≥ 100,000/mm3.
• Life expectancy of at least 3 months at the time of screening as judged by the investigator.
• Treated with or eligible to commence prophylactic treatment with a proton-pump inhibitor prior to implantation, and to continue to receive treatment for at least 6 months post implantation.

You may not qualify if:

• Evidence of distant metastases, based on review of baseline CT scan, as determined by the central reading centre.
• More than one primary lesion.
• Any prior radiotherapy or chemotherapy for pancreatic cancer.
• Use of other investigational agent at the time of screening, or within 30 days or five half-lives of Screening Visit 1, whichever is longer.
• Pregnant or lactating.
• In the opinion of the investigator, EUS directed implantation posing undue study participant 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. Note: The feasibility of implantation of the target tumour and assessment of risk can be conducted at any time between Screening Visit 1 and the implantation date. A study participant should be considered for withdrawal prior to and including at the time of OncoSil™ treatment, if any of the above risk features become apparent following subject screening and/or enrolment.
• History of malignancy, treated or untreated, within the past five years whether or not there is evidence of local recurrence or metastases, with the exception of basal cell carcinoma of the skin and cervical carcinoma in situ.
• Evidence of radiographic invasion into stomach, duodenum or peritoneum (if not certain confirmation must be obtained prior to enrolment).
• A known allergy or history of hypersensitivity to silicon, phosphorous or any of the OncoSil™ components.
• Any other health condition that would preclude participation in the study in the judgment of the investigator.
• Note: T1-T3 is determined as per The American Joint Committee on Cancer (AJCC) tumor/node/metastasis (TNM) classification and staging system for pancreatic cancer

Sponsors & Collaborators

• OncoSil Medical Limited: lead

Study Sites (12)

Corrimal Cancer Care Clinic, 20-22 Underwood St

Corrimal, New South Wales, 2518, Australia

Location

Department of Medical Oncology, Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

The Kinghorn Cancer Centre, St Vincent's Hospital

Sydney, New South Wales, 2010, Australia

Location

The Crown Princess Mary Cancer Centre, Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Department of Gastroenterology and Hepatology, Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Institute for Breathing and Sleep -Bowen CentreAustin Health

Heidelberg, Victoria, 3084, Australia

Location

Monash Cancer Centre

Melbourne, Victoria, 3165, Australia

Location

Institut Jules Bordet

Brussels, Belgium

Location

Cambridge Cancer Trials Centre, Addenbrooke's Hospital

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

Leicester Royal Infirmary

Leicester, East Midlands, LEI 5WW, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust,

London, Greater London, SE19RT, United Kingdom

Location

Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

Related Publications (1)

• Naidu J, Bartholomeusz D, Zobel J, Safaeian R, Hsieh W, Crouch B, Ho K, Calnan D, Singhal N, Ruszkiewicz A, Chen JW, Tan CP, Dolan P, Nguyen NQ. Combined chemotherapy and endoscopic ultrasound-guided intratumoral 32P implantation for locally advanced pancreatic adenocarcinoma: a pilot study. Endoscopy. 2022 Jan;54(1):75-80. doi: 10.1055/a-1353-0941. Epub 2021 Jan 14.

  PMID: 33440437 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul J Ross, MRCP MBBS

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: December 26, 2016
• Study Start: March 27, 2017
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: July 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (7); GB (4); BE (1)