Trial Information

A Phase IIa, Safety Study of the Active Implantable(Radiological) Medical Device 32P BioSilicon, Administered Intratumourally to Patients With Advanced, Unresectable Pancreatic Cancer, in Addition to Standard IV Gemcitabine Chemotherapy

This will be an open label, Phase IIa safety study recruiting about 15 patients from at
least two sites. All patients will have 32P BioSilicon implanted into the pancreatic tumour
as a single implant, using endoscopic ultrasound. The study will examine the safety of an
injected activity equivalent to an absorbed dose of 100 Gy (which is considered to be an
initial low risk radioactivity level), administered intratumourally to patients with
pancreatic cancer. All patients will receive gemcitabine treatment within 2 weeks prior to
or within 3 days of implantation. Any dose adjustments to the gemcitabine treatment will be
made according to the clinical judgement of the oncologist in the team and this will be made
in accordance with the current approved prescribing receommendations. Implantation of 32P
BioSilicon will be performed endoscopically by a trained endoscopist and a nuclear medicine
physician. The 32P BioSilicon will be prepared by a designated personnel licenced to handle
radioactive products and all radioactive waste will be handled and managed as per the
institution's guidelines and in compliance with local regulatory requirements.
Bremsstrahlung imaging will be performed post implantation as a preliminary indication of
localisation of the implanted 32P BioSiliconTM.

Assessments will be performed for haematology, biochemistry, CA19-9 marker, performance
status and any adverse event observed or reported will be graded according to the CTCAE. To
minimise inter-observer variation, the patient should be assessed by the same investigator
throughout the study. Tumour assessment and tumour volume calculation will be performed by
designated radiologists who are independent of the study. To standardise, the CT scans will
be performed according to an agreed scanning protocol and the images will be captured in a
DICOM format at site for assessment by the independent radiologist. Tumour response will be
evaluated only for target tumours using RECIST.

Pain assessment using the Brief Pain Inventory (BPI) pain score will be recorded by the
patient.

Patients who have clinically and/or radiologically stable or responding disease have the
option to continue gemcitabine, at the discretion of the investigator. Following
discontinuation from the study, patients will be followed up for progression-free, and
overall survival.

A Data Monitoring Committee will review the study data at regular teleconference throughout
the study.