Pancreatic CancerPhase 2NCT00346281
32P BioSiliconTM in Addition to Gemcitabine in Pancreatic Cancer
A Phase 2 study testing 32P BioSilicon in people with Pancreatic Cancer, run by pSiMedica Limited at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- 32P BioSilicon
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2006to Jun 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven locally advanced or metastatic adenocarcinoma of the pancreas
- Advanced pancreatic disease, not amenable to surgical resection
- Measurable disease by CT scan, with a tumour burden equivalent to a diameter of no less than 3cm and no greater than 6cm
- ECOG Performance status 0 - 2
- Life expectancy at least three months
- Laboratory parameters:
Show all 9Show fewer
- Hb greater than or equal to 10 g/dl Platelets greater than or equal to 100,000 mm3 ANC greater than or equal to 1500/mm3 Bilirubin < 1.3 x ULN Alkaline phosphatase < 5 x ULN Transaminases < 5 x ULN Creatinine < 1.5 x ULN Prothrombin (PT) and partial thromboplastin time (PTT) within normal range Serum calcium within normal range
- All patients of reproductive potential must agree to use an effective barrier method of contraception during the study and for six months following termination of treatment.
- Male and female patients aged 18 or over who have provided written informed consent
Who cannot join
- Any previous treatment with 32 Phosphorus or with 32P BioSiliconTM
- Any prior radiotherapy for pancreatic cancer
- Use of other investigational agent at the time of enrolment, or within 30 days or five half-lives of enrolment, whichever is longer
- History of hypersensitivity to any of the study products or to products with similar chemical structures (i.e. silicon or phosphorous)
- History of malignancy of any other organ system, treated or untreated, within the past five years whether or not there is evidence of local recurrence or metastases, with the exception of localised basal cell carcinoma of the skin and in situ cervical carcinoma
- Pregnant or lactating women
- Significant tumour related pain for which analgesic intervention incorporating epidural or EUS is planned
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Singapore1 site, 1 recruiting
- Recruiting
Singapore General Hospital
Outram Road, 169608
Pierce KH Chow, MBBS,PhD, +65 6326 6091, gsupc@singnet.com.sg
K F Foo, MBBS, MMed, +65 6436 8445, dmofkf@nccs.com.sg
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's and St Thomas' Hospital NHS Trust
London, SE1 9RT
Paul Ross, MBBS,PhD, 020 7188 4249, paul.ross@gstt.nhs.uk
Paul Ross, MBBS, PhD
About this study
Official title: 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 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.
Read the detailed description
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.
- Conditions
- Pancreatic Cancer
- Being tested
- 32P BioSilicon
- Keywords
- unresectable pancreatic cancer, brachytherapy, 32P, BioSilicon, locally advanced, gemcitabine, intratumourally, unresectable
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
32P BioSiliconDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety profile of the patients defined by the Adverse Events profile.
Secondary outcomes (1)
Will assess ease of use, tumour response, duration of response, progression free survival and overall survival. Target tumour response summaries for the study will be performed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2006 (estimated)
- Study startJun 2006
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- pSiMedica Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- pSiOncology Private Limited, Singapore General Hospital, Guy's and St Thomas' NHS Foundation Trust
- Investigators
- Pierce KH Chow, MBBS, PhD, Principal investigator, Singapore General HospitalPaul Ross, MBBS,PhD, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00346281
- Sponsor's protocol ID
- DB2-201
- Status last verified
- Jun 2006
- First submitted
- 27 Jun 2006
- Last updated
- 29 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00346281
- Acronym / sponsor ID
- DB2-201
- Conditions
- Pancreatic Cancer
- Keywords
- unresectable pancreatic cancer, brachytherapy, 32P, BioSilicon, locally advanced, gemcitabine, intratumourally, unresectable
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants
- Lead sponsor
- pSiMedica LimitedIndustry (pharma, biotech, devices)
- Collaborators
- pSiOncology Private Limited, Singapore General Hospital, Guy's and St Thomas' NHS Foundation Trust
- Study start
- Jun 2006
- Study completion
- Jun 2008
- First posted
- 29 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically proven locally advanced or metastatic adenocarcinoma of the pancreas
- Advanced pancreatic disease, not amenable to surgical resection
- Measurable disease by CT scan, with a tumour burden equivalent to a diameter of no less than 3cm and no greater than 6cm
- ECOG Performance status 0 - 2
- Life expectancy at least three months
Key exclusion criteria (7 listed)
- Any previous treatment with 32 Phosphorus or with 32P BioSiliconTM
- Any prior radiotherapy for pancreatic cancer
- Use of other investigational agent at the time of enrolment, or within 30 days or five half-lives of enrolment, whichever is longer
- History of hypersensitivity to any of the study products or to products with similar chemical structures (i.e. silicon or phosphorous)
- History of malignancy of any other organ system, treated or untreated, within the past five years whether or not there is evidence of local recurrence or metastases, with the exception of localised basal cell carcinoma of the skin and in situ cervical carcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 32P BioSilicon | Device | – |
Primary outcome
Safety profile of the patients defined by the Adverse Events profile.
1 secondary outcome
Will assess ease of use, tumour response, duration of response, progression free survival and overall survival. Target tumour response summaries for the study will be performed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2006.
- BrachySil A Novel Targeted Cancer TherapyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierce KH Chow, MBBS, PhD principal investigator
Singapore General Hospital
Paul Ross, MBBS,PhD principal investigator
Guy's and St Thomas' NHS Foundation Trust
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 32P BioSilicon in people with Pancreatic Cancer, run by pSiMedica Limited at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety profile of the patients defined by the Adverse Events profile.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2006.