NCT03076216

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: OncoSil Medical Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Unresectable Locally Advanced Pancreatic Carcinoma

Interventions

Type	Name	Description
DEVICE	OncoSil™	The implantation of OncoSil™ under EUS

Timeline

• Start date: 2017-08-01
• Primary completion: 2020-11-28
• Completion: 2020-11-28
• First posted: 2017-03-10
• Last updated: 2021-07-13

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study