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Gemcitabine

32P BioSilicon

Pierce KH Chow, MBBS,PhD

K F Foo, MBBS, MMed

Steven Mesenas, MBBS, MRCP

Anthony SW Goh, MBBS, MSc

W K Wong, MBBS

Alexander YF Chung, MBBS

P C Cheow, MBBS, MMed

David CE Ng, MBBS, MSc

S. Somanesan, BSc (Hons)

K M Hoi, BSc (Hons)

Paul Ross, MBBS,PhD

Paul Ross, MBBS, PhD

David Landau, MBBS, MRCP

Peter Harper, MBBS, MRCP

John Meenan, MBBS, PhD

Mike O'Doherty, MBBS, MD

Jim Ballinger, PhD

Stanley Batchelor, MSc

Pierce KH Chow, MBBS, PhD

This is the first study investigating the safety of 32P BioSilicon in patients with advanced,unresectable pancreatic cancer who are also receiving standard intravenous gemcitabine chemotherapy. The secondary aims of the study will assess the implantation procedure, localisation of 32P BioSilicon, tumour response and survival parameters.

Tumours targetted with 32P BioSilicon is hypothesized to show a reduction in tumour volume and with the low radioactivity dose that is delivered intratumourally, the incidence of side effects associated with the treatment is expected to be low. Prologation of survival and improved quality of life could be favourable outcomes of the investigational product.

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.

32P BioSiliconTM in Addition to Gemcitabine in Pancreatic Cancer

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

pSiOncology Private Limited

Singapore General Hospital

Guy's and St Thomas' NHS Foundation Trust

pSiMedica Limited

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Diseases

Primary Liver Cancer

Hematinics

Liver Extracts

Pierce Chow

Brachytherapy is a recent technique used in the treatment of tumours and involves the use of radioactive sources brought into close contact with the target tissues. One of the principal benefits of brachytherapy is that high radiation doses can be localised within the tumour with the consequence of minimal side effects. 32P is a radionuclide ideal for brachytherapy as it has high energy beta emitting properties, typically a maximum tissue range of about 8 mm and a half life of 14.3 days. 32P BioSiliconTM is an active implantable medical device encapsulating 32P within the internal microcrystalline structure of highly pure inert silicon and acts as a sealed source for the provision of 32 phosphorous.

Tumours targeted with 32P BioSiliconTM are hypothesized to show a reduction in volume with a low incidence of side effects associated with the treatment. Prolongation of survival and improved quality of life would be favourable outcomes of the investigational product.

The study will enroll between 48 to 50 patients from all sites. Patients will be enrolled sequentially into the three groups, starting wth Group 1 which will investigate the lower radioactivity level and then progress to a higher radioactivity level in Group 2 and then Group 3. The approval to enrol patients into the next group will be assessed and determined by a Data Monitoring Board. All patients will be followed up to 52 weeks from the start date of primary implantations.

Patients will receive intratumoural implantations of 32P BioSiliconTM under imaging guidance and local anaesthesia by designated interventional radiologists, using the SIMPL needle or conventional needles depending on the size and location of the tumour as assessed by the designated interventional radiologists. There are only a designated number of sites that will perform the implantation procedure although there are multiple sites recruiting and following up with patients.

* Tumour assessment, tumour calculation and measurement will be performed by an independent radiologist. CT scans from all participating sites will be sent in DICOM format to the designated radiologist for assessment.
* Safety assessment and grading of CTCAE will be performed by the same investigator for that same patient throughout the entire study period. There will be an interim analysis when all patients complete 24 weeks evaluating the safety profile and target tumour response of the patients.
* 32P BioSiliconTM will be prepared by designated personnel licensed to handle radioactive products and all radioactive waste will be handed and managed as per the institution's guidelines and in compliance with local regulatory requirements.

Safety of 32P BioSilicon in Patients With Hepatocellular Carcinoma

A Study of the Safety Profile of Three Escalating Radioactivity Levels of 32P BioSilicon Delivered With the SIMPL Needle as Intratumoural Implantations in Patients With Unresectable Hepatocellular Carcinoma

pSiVida Limited

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
32P BioSiliconTM in Addition to Gemcitabine in Pancreatic Cancer	NCT00346281	Pancreatic Canc...	32P BioSilicon	18 Years -	pSiMedica Limited
32P BioSiliconTM in Addition to Gemcitabine in Pancreatic Cancer	NCT00346281	Pancreatic Canc...	32P BioSilicon	18 Years -	pSiMedica Limited
Safety of 32P BioSilicon in Patients With Hepatocellular Carcinoma	NCT00247260	Liver Cancer	32P BioSilicon	18 Years -	pSiVida Limited

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