Clinical Trial 19185

Cancer Type: Gastrointestinal Tumor
Interventions:Gemzar (gemcitabine); Nab-paclitaxel (Abraxane); OncoSil Microparticles / Diluent; gemcitabine

Study Type: Treatment
Phase of Study: NA
Investigators:


    Overview

    Study 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

    Summary

    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, who are already receiving standard chemotherapy. OncoSil, is an experimental treatment. This means that it is not an approved treatment for pancreatic cancer anywhere in the world at this time.

    Objective

    To evaluate the safety of OncoSil. 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.

    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 Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 and Karnofsky Performance Status of 80 - 100
  • ≥ 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 participant
  • A Prothrombin Time (PT) or Partial Thromboplastin Time (PTT) within normal range
  • Adequate bone marrow function: white blood cells (WBCs) ≥ 3,000/mm^3, absolute neutrophil count (ANC) ≥ 1,500/mm^3, hemoglobin ≥ 9 g/dL, and platelets ≥ 100,000/mm^3
  • 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.

  • 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