Unresectable Locally Advanced Pancreatic CarcinomaOncoPaC-1NCT03076216
A Pilot Study of OncoSil™ Given to Patients With Pancreatic Cancer Treated With Gemcitabine +/- Nab-paclitaxel.
A study testing OncoSil™ in people with Unresectable Locally Advanced Pancreatic Carcinoma, run by OncoSil Medical Limited at 4 sites in United States.
Trial 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 FDA regulatory requirements. The clinical investigation will be conducted at approximately 5 sites in the United States involving 20 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Locally Advanced Pancreatic Carcinoma
- What is being tested?
- OncoSil™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Aug 2017to 28 Nov 2020
- Phase
- Interventional
- 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 or cytologically proven adenocarcinoma of the pancreas.
- Stage III unresectable locally advanced pancreatic carcinoma. Patients with technically resectable tumors (T1-T3) will also be eligible, if they are deemed unresectable due to medical comorbidities or refusal of surgery.
- Pancreatic target tumor diameter of ≥ 2.0 cm (shortest axis) to ≤ 6.0 cm (longest axis), as qualified by the central reading center.
- An ECOG Performance Status of 0 to 1 and Karnofsky Performance Status of 80 - 100.
- Study participants' ≥ 18 years of age at screening.
- To commence first-line standard gemcitabine and nab-paclitaxel chemotherapy, or gemcitabine alone, (per standard of care (SoC) according to the approved prescribing schedule), within 14 days post enrollment, with OncoSil™ implantation to occur during the fourth (4th) week of the first chemotherapy cycle.
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- Provide signed Informed Consent.
- Willing and able to complete study procedures within the study timelines.
- Adequate renal function: serum creatinine less than 1.5 x upper limit of normal (ULN).
- 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.
- Adequate bone marrow function: white blood cells (WBCs) ≥ 3,000/mm3, absolute neutrophil count (ANC) ≥ 1,500/mm3, hemoglobin ≥ 9 g/dL, and platelets ≥ 100,000/mm3.
- Life expectancy of at least 3 months at the time of screening as judged by the investigator.
- 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.
- 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.
- -
Who cannot join
- Evidence of distant metastases, based on review of baseline CT scan, as determined by the central reading center.
- More than one primary lesion.
- Any prior radiotherapy or chemotherapy for pancreatic cancer.
- 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.
- Pregnant or lactating.
- In the opinion of the investigator, EUS directed implantation posing undue study participant risk. This includes:
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- where previous EUS-FNA was considered technically too difficult to perform;
- imaging demonstrates multiple collateral vessels surrounding or adjacent to the target tumor within the pancreas;
- presence (or significant risk) of varices near to the target tumor. Note: The feasibility of implantation of the target tumor 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 study participant screening and/or enrolment.
- 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.
- Evidence of radiographic invasion into stomach or duodenum (if not certain, confirmation must be obtained prior to enrolment).
- A known history of hypersensitivity to silicon or phosphorous, or any of the OncoSil™ components.
- Any other health condition that would preclude participation in the study in the judgement of the investigator.
- -
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
MD Anderson Cancer Center
Houston, Texas, 77030
Cedars Sinai Department of Radiation Oncology
Los Angeles, California, 90048
Moffitt Cancer Centre
Tampa, Florida, 33612
About this study
Official title: An Open Label, Single Arm Pilot Study of OncoSil™, Administered to Subjects With Unresectable Locally Advanced Pancreatic Adenocarcinoma, Given in Combination With Gemcitabine or Gemcitabine+Nab-paclitaxel Chemotherapies
To evaluate the safety of OncoSil™ in a patient population undergoing standard chemotherapy treatment for pancreatic cancer. This study has been designed to satisfy FDA regulatory requirements.
The clinical investigation will be conducted at approximately 5 sites in the United States involving 20 patients.
Read the detailed description
The purpose of this research study is to investigate the safety of an active implantable (radiological) medical device OncoSil™, when implanted into patients with pancreatic cancer, in conjunction with Standard chemotherapy. OncoSil™, is an experimental treatment and carries the active treatment "radioactive Phosphorous (32P)" inside inactive silicon particles. Once implanted, the OncoSil™ Microparticles will stay in the tumour permanently. The purpose of OncoSil™, is to deliver the action of 32P directly into a targeted tumour to destroy cancer cells.
20 Patients will be taking part in a single arm open label research study - which means that everyone in the research study will receive the investigational treatment OncoSil™, plus their prescribed standard chemotherapy regimen which will be either Gemcitabine or Gemcitabine + nab-paclitaxel (Abraxane).
Endpoints: Primary Endpoint:
- Safety and Tolerability
Secondary Endpoints:
Efficacy
- Local Progression Free Survival (LPFS), within the pancreas
- Progression Free Survival (PFS), all sites
- Overall Survival (OS)
- Body weight
- Impaired function
- Pain Scores
The screening period will be performed within a 2 week period, followed by a treatment period of investigational visits which will occur weekly from Day 0 (Visit 1) until week 12, then 4 weeks later at week 16, and then at 8-weekly intervals until study participants reach documented progression of disease criteria for both LPFS and PFS which marks the end of study participation i.e. EOS visit.
8 weekly telephone contact will be used to monitor device or late radiation related adverse events, and oncology treatments/procedures administered for up to 12 months post OncoSil™ implantation. Overall survival will be conducted via 8 weekly medical record reviews and or telephone contact until subject death, or until 104 weeks post the last subject enrolled.
Overall survival will be conducted via 8-weekly medical record reviews until study participant death, or until 104 weeks post the last study participant enrolled.
Activity (Dose): The intended average absorbed radiation dose per treated tumour is 100 Gy (+20%).
Risks associated with OncoSil™ and/or implantation procedure
The following adverse events, considered to have a causal relationship with OncoSil™ or procedure, were recorded during previous clinical studies:
- Procedure-related pain
- Abdominal pain and discomfort
- Lethargy
- Fever
- Nausea and vomiting
- Abnormal liver function tests
- Being tested
- OncoSil™
- Keywords
- Pancreatic Cancer, Pancreas, metastases, pancreatic tumour, unresectable, locally advanced, implantable, radiographic, device, Phosphorous-32 (P32), OncoSil™, brachytherapy, gemcitabine, nab-paclitaxel, Abraxane
- Medical subject headings
- Pancreatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OncoSil™Device
The implantation of OncoSil™ under EUS
| Study group | Role | What they receive |
|---|---|---|
| OncoSil™ plus SOC Chemotherapy | Other | OncoSil™ implanted with concurrent Standard of Care chemotherapy either gemcitabine or gemcitabine + Abraxane Receives: Device: OncoSil™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety / Tolerability of Device as determined by the number of treatment emergent adverse events (TEAEs) evaluated according to CTCAE V4.0
as determined by the number of treatment emergent adverse events (TEAEs) evaluated according to CTCAE V4.0
Measured: Collected from the of signed informed consent until patient death or 104 weeks post last patient enrollment date, whichever is sooner]
Secondary outcomes (6)
Local Progression free survival within the pancreas
As assessed by the central reader review of successive CT scans throughout the study
Measured: Assessed from Baseline through to first confirmed CT documentation of local progression within the pancreas, an average of 12 months
Progression free survival - entire body
As assessed by the central reader review of successive CT scans throughout the study
Measured: Assessed from Baseline through to EOS visit - an average of 12 months
Overall survival
As assessed by the time from participant consent to participant death or their survival to 104 weeks past the first study visit on the last subject enrolled in the study.
Measured: Assessed from Baseline to 104 weeks post last patient first study visit]
Body weight
Measurement of subject body weight at each study visit
Measured: Assessed from Baseline through to EOS visit, an average of 12 months
Impaired function
as measured by changes in the Karnofsky Performance Status from screening
Measured: Measured at each study visit for the duration of the study, an average of 12 months
Pain Scores
Pain as measured by the numerical rating scale (NRS) at each study visit
Measured: Measured at each study visit for the duration of the study, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start1 Aug 2017
- Primary completion28 Nov 2020
- Study completion28 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Locally Advanced Pancreatic CarcinomaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- OncoSil Medical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph M Herman, M.D., M.Sc., Principal investigator, MD Anderson Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076216
- Sponsor's protocol ID
- ONC01P01
- Acronym
- OncoPaC-1
- Status last verified
- Mar 2020
- First submitted
- 6 Mar 2017
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single Arm Pilot Study of OncoSil™, Administered to Subjects With Unresectable Locally Advanced Pancreatic Adenocarcinoma, Given in Combination With Gemcitabine or Gemcitabine+Nab-paclitaxel Chemotherapies
- ClinicalTrials.gov ID
- NCT03076216
- Acronym / sponsor ID
- OncoPaC-1 / ONC01P01
- Keywords
- Pancreatic Cancer, Pancreas, metastases, pancreatic tumour, unresectable, locally advanced, implantable, radiographic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- OncoSil Medical LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 28 Nov 2020 (actual)
- Study completion
- 28 Nov 2020 (actual)
- First posted
- 10 Mar 2017 (actual)
- 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.
To evaluate the safety of OncoSil™ in a patient population undergoing standard chemotherapy treatment for pancreatic cancer. This study has been designed to satisfy FDA regulatory requirements.
The clinical investigation will be conducted at approximately 5 sites in the United States involving 20 patients.
Detailed description
The purpose of this research study is to investigate the safety of an active implantable (radiological) medical device OncoSil™, when implanted into patients with pancreatic cancer, in conjunction with Standard chemotherapy. OncoSil™, is an experimental treatment and carries the active treatment "radioactive Phosphorous (32P)" inside inactive silicon particles. Once implanted, the OncoSil™ Microparticles will stay in the tumour permanently. The purpose of OncoSil™, is to deliver the action of 32P directly into a targeted tumour to destroy cancer cells.
20 Patients will be taking part in a single arm open label research study - which means that everyone in the research study will receive the investigational treatment OncoSil™, plus their prescribed standard chemotherapy regimen which will be either Gemcitabine or Gemcitabine + nab-paclitaxel (Abraxane).
Endpoints: Primary Endpoint:
- Safety and Tolerability
Secondary Endpoints:
Efficacy
- Local Progression Free Survival (LPFS), within the pancreas
- Progression Free Survival (PFS), all sites
- Overall Survival (OS)
- Body weight
- Impaired function
- Pain Scores
The screening period will be performed within a 2 week period, followed by a treatment period of investigational visits which will occur weekly from Day 0 (Visit 1) until week 12, then 4 weeks later at week 16, and then at 8-weekly intervals until study participants reach documented progression of disease criteria for both LPFS and PFS which marks the end of study participation i.e. EOS visit.
8 weekly telephone contact will be used to monitor device or late radiation related adverse events, and oncology treatments/procedures administered for up to 12 months post OncoSil™ implantation. Overall survival will be conducted via 8 weekly medical record reviews and or telephone contact until subject death, or until 104 weeks post the last subject enrolled.
Overall survival will be conducted via 8-weekly medical record reviews until study participant death, or until 104 weeks post the last study participant enrolled.
Activity (Dose): The intended average absorbed radiation dose per treated tumour is 100 Gy (+20%).
Risks associated with OncoSil™ and/or implantation procedure
The following adverse events, considered to have a causal relationship with OncoSil™ or procedure, were recorded during previous clinical studies:
- Procedure-related pain
- Abdominal pain and discomfort
- Lethargy
- Fever
- Nausea and vomiting
- Abnormal liver function tests
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OncoSil™ plus SOC Chemotherapy | Other | Device: OncoSil™OncoSil™ implanted with concurrent Standard of Care chemotherapy either gemcitabine or gemcitabine + Abraxane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically or cytologically proven adenocarcinoma of the pancreas.
- Stage III unresectable locally advanced pancreatic carcinoma. Patients with technically resectable tumors (T1-T3) will also be eligible, if they are deemed unresectable due to medical comorbidities or refusal of surgery.
- Pancreatic target tumor diameter of ≥ 2.0 cm (shortest axis) to ≤ 6.0 cm (longest axis), as qualified by the central reading center.
- An ECOG Performance Status of 0 to 1 and Karnofsky Performance Status of 80 - 100.
- Study participants' ≥ 18 years of age at screening.
Key exclusion criteria (14 listed)
- Evidence of distant metastases, based on review of baseline CT scan, as determined by the central reading center.
- More than one primary lesion.
- Any prior radiotherapy or chemotherapy for pancreatic cancer.
- 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.
- Pregnant or lactating.
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 |
|---|---|---|
| OncoSil™The implantation of OncoSil™ under EUS | Device | OncoSil™ plus SOC Chemotherapy |
Primary outcome
Safety / Tolerability of Device as determined by the number of treatment emergent adverse events (TEAEs) evaluated according to CTCAE V4.0
Time frame: Collected from the of signed informed consent until patient death or 104 weeks post last patient enrollment date, whichever is sooner]
as determined by the number of treatment emergent adverse events (TEAEs) evaluated according to CTCAE V4.0
6 secondary outcomes
Local Progression free survival within the pancreas
Time frame: Assessed from Baseline through to first confirmed CT documentation of local progression within the pancreas, an average of 12 months
Progression free survival - entire body
Time frame: Assessed from Baseline through to EOS visit - an average of 12 months
Overall survival
Time frame: Assessed from Baseline to 104 weeks post last patient first study visit]
Body weight
Time frame: Assessed from Baseline through to EOS visit, an average of 12 months
Impaired function
Time frame: Measured at each study visit for the duration of the study, an average of 12 months
Pain Scores
Time frame: Measured at each study visit for the duration of the study, an average of 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Joseph M Herman, M.D., M.Sc. principal investigator
MD Anderson Cancer Centre
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OncoSil™ in people with Unresectable Locally Advanced Pancreatic Carcinoma, run by OncoSil Medical Limited at 4 sites in United States.
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 16 inclusion and 14 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: finished, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety / Tolerability of Device as determined by the number of treatment emergent adverse events (TEAEs) evaluated according to CTCAE V4.0 (time frame: Collected from the of signed informed consent until patient death or 104 weeks post last patient enrollment date, whichever is sooner]). 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 13 Jul 2021.