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A Pilot Study of OncoSil™ Given to Patients With Pancreatic Cancer Treated With Gemcitabine +/- Nab-paclitaxel. (OncoPaC-1)

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ClinicalTrials.gov Identifier: NCT03076216
Recruitment Status : Active, not recruiting
First Posted : March 10, 2017
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
OncoSil Medical Limited

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.


Condition or disease Intervention/treatment Phase
Unresectable Locally Advanced Pancreatic Carcinoma Device: OncoSil™ Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021


Arm Intervention/treatment
OncoSil™ plus SOC Chemotherapy
OncoSil™ implanted with concurrent Standard of Care chemotherapy either gemcitabine or gemcitabine + Abraxane
Device: OncoSil™
The implantation of OncoSil™ under EUS




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
    As assessed by the central reader review of successive CT scans throughout the study

  2. Progression free survival - entire body [ Time Frame: Assessed from Baseline through to EOS visit - an average of 12 months ]
    As assessed by the central reader review of successive CT scans throughout the study

  3. Overall survival [ Time Frame: Assessed from Baseline to 104 weeks post last patient first study visit] ]
    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.

  4. Body weight [ Time Frame: Assessed from Baseline through to EOS visit, an average of 12 months ]
    Measurement of subject body weight at each study visit

  5. Impaired function [ Time Frame: Measured at each study visit for the duration of the study, an average of 12 months ]
    as measured by changes in the Karnofsky Performance Status from screening

  6. Pain Scores [ Time Frame: Measured at each study visit for the duration of the study, an average of 12 months ]
    Pain as measured by the numerical rating scale (NRS) at each study visit


Other Outcome Measures:
  1. Tumor Response [ Time Frame: 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 ]
    as demonstrated by target tumour volumetric change (measured by a central reading centre)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically proven adenocarcinoma of the pancreas
  • Stage III unresectable locally advanced pancreatic carcinoma
  • Pancreatic target tumor diameter of ≥ 2.0 cm (shortest axis) to ≤ 6.0 cm (longest axis) and a minimum tumor volume of 14.0 cc as qualified by the central reading center
  • An ECOG Performance Status of 0 to 1 and Karnofsky Performance Status of 80 - 100
  • Subjects ≥ 18 years of age at screening
  • To commence first-line standard nab-paclitaxel and gemcitabine chemotherapy, or gemcitabine alone, (per standard of care according to the approved prescribing schedule), within 7 to 14 days post enrolment, 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 glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST) and serum glutamic pyruvic transaminase/alanine aminotransferase (SGPT/ALT) ≤ 2 × ULN and serum bilirubin ≤ 1.5 × ULN unless Gilbert's syndrome has previously been confirmed for the subject
  • A Prothrombin Time (PT) or Partial Thromboplastin Time (PTT) within normal range
  • 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 (refer to Section 7.3 Permissible and Prohibited Medications/Treatments)

Exclusion Criteria:

  • Evidence of distant metastases as determined by the central reading committee
  • 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 1, whichever is longer
  • Pregnant or lactating
  • In the opinion of the investigator, EUS directed implantation posing undue subject risk e.g. previous EUS-FNA was considered technically too difficult to perform, or imaging demonstrates multiple collateral vessels surrounding or adjacent to the target tumor
  • 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, duodenum or peritoneum (if not certain confirmation must be obtained prior to enrolment)
  • A known allergy or history of hypersensitivity to silicon, phosphorous or any of the OncoSil™ components
  • Any other health condition that would preclude participation in the study in the judgment of the principal investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076216


Locations
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United States, California
Cedars Sinai Department of Radiation Oncology
Los Angeles, California, United States, 90048
United States, Florida
Moffitt Cancer Centre
Tampa, Florida, United States, 33612
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
OncoSil Medical Limited
Investigators
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Principal Investigator: Joseph M Herman, M.D., M.Sc. MD Anderson Cancer Centre

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Responsible Party: OncoSil Medical Limited
ClinicalTrials.gov Identifier: NCT03076216     History of Changes
Other Study ID Numbers: ONC01P01
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by OncoSil Medical Limited:
Pancreatic Cancer
Pancreas
metastases
pancreatic tumour
unresectable
locally advanced
implantable
radiographic
device
Phosphorous-32 (P32)
OncoSil™
brachytherapy
gemcitabine
nab-paclitaxel
Abraxane
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs