A Pilot Study of OncoSil™ Given to Patients With Pancreatic Cancer Treated With Gemcitabine +/- Nab-paclitaxel.

NCT03076216 | Completed DMC FDA Device

• 1 other identifier: ONC01P01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 4

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 FDA regulatory requirements. The clinical investigation will be conducted at approximately 5 sites in the United States involving 20 patients.

Conditions

Unresectable Locally Advanced Pancreatic Carcinoma

Keywords

Pancreatic Cancer; Pancreas; metastases; pancreatic tumour; unresectable; locally advanced; implantable; radiographic; device; Phosphorous-32 (P32); OncoSil™; brachytherapy; gemcitabine; nab-paclitaxel; Abraxane

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  Assessed from Baseline through to EOS visit - an average of 12 months

• Overall survival

  Assessed from Baseline to 104 weeks post last patient first study visit]

• Body weight

  Assessed from Baseline through to EOS visit, an average of 12 months

• Impaired function

  Measured at each study visit for the duration of the study, an average of 12 months

Other Outcomes (1)

• Tumor Response

  Baseline measure from screening period, compared to Week 8 CT result, and then to 8 weekly CT results until local progression is determined, an average of 12 months

Study Arms (1)

OncoSil™ plus SOC Chemotherapy

OTHER

OncoSil™ implanted with concurrent Standard of Care chemotherapy either gemcitabine or gemcitabine + Abraxane

Device: OncoSil™

Interventions

OncoSil™ DEVICE

The implantation of OncoSil™ under EUS

OncoSil™ plus SOC Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• OncoSil Medical Limited: lead

Study Sites (4)

Cedars Sinai Department of Radiation Oncology

Los Angeles, California, 90048, United States

Location

Moffitt Cancer Centre

Tampa, Florida, 33612, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseph M Herman, M.D., M.Sc.

  MD Anderson Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 10, 2017
• Study Start: August 1, 2017
• Primary Completion: November 28, 2020
• Study Completion: November 28, 2020
• Last Updated: July 13, 2021

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)