Unresectable Locally Advanced Pancreatic Carcinoma Clinical Trial
— PanCOOfficial title:
An Open Label, Single Arm Pilot Study of OncoSil™, Administered to Study Participants With Unresectable Locally Advanced Pancreatic Adenocarcinoma, Given in Combination With FOLFIRINOX or Gemcitabine+Nab-paclitaxel Chemotherapies
NCT number | NCT03003078 |
Other study ID # | ONC01P03 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 27, 2017 |
Est. completion date | July 31, 2020 |
Verified date | July 2021 |
Source | OncoSil Medical Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | July 31, 2020 |
Est. primary completion date | July 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Histologically or cytologically proven adenocarcinoma of the pancreas. 2. 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. 3. Pancreatic target tumour diameter of = 2.0 cm (shortest axis) to = 6.0 cm (longest axis), as qualified by the central reading centre. 4. An ECOG Performance Status of 0 to 1 and Karnofsky Performance Status of 80 - 100. 5. Study participants = 18 years of age at screening. 6. 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. 7. Provide signed Informed Consent. 8. Willing and able to complete study procedures within the study timelines. 9. Adequate renal function: serum creatinine less than 1.5 x upper limit of normal (ULN). 10. 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. 11. 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. 12. Life expectancy of at least 3 months at the time of screening as judged by the investigator. 13. 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. 14. Not pregnant, and if of childbearing potential, agrees to use adequate birth control (hormonal or barrier method of birth control or abstinence) prior to study entry and during the study and agrees not to donate sperm or ova, for the duration of the study and 12 months post implantation of the investigational device. Exclusion Criteria 1. Evidence of distant metastases, based on review of baseline CT scan, as determined by the central reading centre. 2. More than one primary lesion. 3. Any prior radiotherapy or chemotherapy for pancreatic cancer. 4. 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. 5. Pregnant or lactating. 6. 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. 7. 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. 8. Evidence of radiographic invasion into stomach, duodenum or peritoneum (if not certain confirmation must be obtained prior to enrolment). 9. A known allergy or history of hypersensitivity to silicon, phosphorous or any of the OncoSil™ components. 10. 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Department of Gastroenterology and Hepatology, Royal Adelaide Hospital | Adelaide | South Australia |
Australia | Corrimal Cancer Care Clinic, 20-22 Underwood St | Corrimal | New South Wales |
Australia | Institute for Breathing and Sleep -Bowen CentreAustin Health | Heidelberg | Victoria |
Australia | Monash Cancer Centre | Melbourne | Victoria |
Australia | Department of Medical Oncology, Royal North Shore Hospital | St Leonards | New South Wales |
Australia | The Kinghorn Cancer Centre, St Vincent's Hospital | Sydney | New South Wales |
Australia | The Crown Princess Mary Cancer Centre, Westmead Hospital | Westmead | New South Wales |
Belgium | Institut Jules Bordet | Bruxelles | |
United Kingdom | Cambridge Cancer Trials Centre, Addenbrooke's Hospital | Cambridge | Cambridgeshire |
United Kingdom | Leicester Royal Infirmary | Leicester | East Midlands |
United Kingdom | Guy's and St Thomas' NHS Foundation Trust, | London | Greater London |
United Kingdom | Hammersmith Hospital | London |
Lead Sponsor | Collaborator |
---|---|
OncoSil Medical Limited |
Australia, Belgium, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | tumour response | as demonstrated by target tumour volumetric change (measured by a central reading centre) | 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. | |
Other | tumour response | as demonstrated by target tumour FDG-PET parameters (measured by a central reading centre) | As assessed at Week 12 study visit compared to Baseline assessment completed during screening period | |
Primary | 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 | Local Progression free survival within the pancreas | Central reader review of CT changes throughout study enrolment | Assessed from Baseline through to first confirmed CT documentation of local progression within the pancreas, an average of 12 months. | |
Secondary | Progression free survival - entire body | Central reader review of CT changes throughout study enrolment | Assessed from Baseline through to EOS visit - an average of 12 months. | |
Secondary | Overall survival | Time to participant death from enrolment | 104 weeks post last patient first study visit | |
Secondary | Body weight | Recorded body weight at each study visit | Assessed from Baseline through to EOS visit, an average of 12 months. | |
Secondary | Impaired function | as measured by changes in the Karnofsky Performance Status from screening | Frame: Measured at each study visit for the duration of the study, an average of 12 months | |
Secondary | Pain Scores | As measured at each study visit using the Numerical Rating scale (NRS) | Measured at each study visit for the duration of the study, an average of 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03076216 -
A Pilot Study of OncoSil™ Given to Patients With Pancreatic Cancer Treated With Gemcitabine +/- Nab-paclitaxel.
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N/A |