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Trial from ClinicalTrials.gov

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

  • Recruitment status at the time of last update
    Active, not recruiting
  • Has the trial been updated in the last 24 months?
    Up to date
    (Last updated: 19/7/2018)
Key trial Information

Trial ID

NCT03003078

Date registered

21 December 2016

Recruitment status

Active, not recruiting

Anticipated date of first participant enrolment

n/a

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

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. Pancreati c 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 glutamic oxaloacetic transaminase/aspartate
aminotransferase (SGOT/AST) and serum glutamic pyruvic transaminase/alanine
aminotransferase (SGPT/ALT) = 2 × ULN and serum bilirubin = 1.5 × ULN unless Gilbert's
syndrome has previously been confirmed for the study participant.

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 (refer to Section 6.3.
Permissible and Prohibited Medications/Treatments.

Minimum age

18 Years

Maximum age

No limit

Gender

Both males and females

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 e.g. previous EUS-FNA was considered technically too difficult to
perform, or imaging demonstrates multiple collateral vessels surrounding or adjacent
to the target tumour.

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

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.