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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03003078




Registration number
NCT03003078
Ethics application status
Date submitted
20/12/2016
Date registered
26/12/2016
Date last updated
26/10/2020

Titles & IDs
Public title
A Pilot Study of OncoSil™ Given to Patients With Pancreatic Cancer Treated With FOLFIRINOX or Gemcitabine+Abraxane
Scientific 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
Secondary ID [1] 0 0
ONC01P03
Universal Trial Number (UTN)
Trial acronym
PanCO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unresectable Locally Advanced Pancreatic Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - OncoSil™

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


Treatment: Devices: OncoSil™
The implantation of OncoSil™

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety / Tolerability of Device according to CTCAE V4.0 - as determined by the number of treatment emergent adverse events (TEAEs) evaluated
Timepoint [1] 0 0
Collected from the of signed informed consent until patient death or 104 weeks post last patient enrollment date, whichever is sooner
Secondary outcome [1] 0 0
Local Progression free survival within the pancreas - Central reader review of CT changes throughout study enrolment
Timepoint [1] 0 0
Assessed from Baseline through to first confirmed CT documentation of local progression within the pancreas, an average of 12 months.
Secondary outcome [2] 0 0
Progression free survival - entire body - Central reader review of CT changes throughout study enrolment
Timepoint [2] 0 0
Assessed from Baseline through to EOS visit - an average of 12 months.
Secondary outcome [3] 0 0
Overall survival - Time to participant death from enrolment
Timepoint [3] 0 0
104 weeks post last patient first study visit
Secondary outcome [4] 0 0
Body weight - Recorded body weight at each study visit
Timepoint [4] 0 0
Assessed from Baseline through to EOS visit, an average of 12 months.
Secondary outcome [5] 0 0
Impaired function - as measured by changes in the Karnofsky Performance Status from screening
Timepoint [5] 0 0
Frame: Measured at each study visit for the duration of the study, an average of 12 months
Secondary outcome [6] 0 0
Pain Scores - As measured at each study visit using the Numerical Rating scale (NRS)
Timepoint [6] 0 0
Measured at each study visit for the duration of the study, an average of 12 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Corrimal Cancer Care Clinic, 20-22 Underwood St - Corrimal
Recruitment hospital [2] 0 0
Department of Medical Oncology, Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 0 0
The Kinghorn Cancer Centre, St Vincent's Hospital - Sydney
Recruitment hospital [4] 0 0
The Crown Princess Mary Cancer Centre, Westmead Hospital - Westmead
Recruitment hospital [5] 0 0
Department of Gastroenterology and Hepatology, Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 0 0
Institute for Breathing and Sleep -Bowen CentreAustin Health - Heidelberg
Recruitment hospital [7] 0 0
Monash Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2518 - Corrimal
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
2010 - Sydney
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
3165 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Bruxelles
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Cambridgeshire
Country [3] 0 0
United Kingdom
State/province [3] 0 0
East Midlands
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Greater London
Country [5] 0 0
United Kingdom
State/province [5] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
OncoSil Medical Limited
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03003078
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul J Ross, MRCP MBBS
Address 0 0
Guy's and St Thomas' NHS Foundation Trust
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications