A Pilot Study of OncoSil™ Given to Patients With Pancreatic Cancer Treated With Gemcitabine +/- Nab-paclitaxel. (OncoPaC-1)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03076216|
Recruitment Status : Active, not recruiting
First Posted : March 10, 2017
Last Update Posted : December 20, 2018
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|
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
- 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
- Nausea and vomiting
- Abnormal liver function tests
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||April 2019|
|Estimated Study Completion Date :||April 2019|
OncoSil™ plus SOC Chemotherapy
OncoSil™ implanted with concurrent Standard of Care chemotherapy either gemcitabine or gemcitabine + Abraxane
The implantation of OncoSil™ under EUS
- 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
- 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
- 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
- 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.
- 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
- 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
- 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
- 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)
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
|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|
|Principal Investigator:||Joseph M Herman, M.D., M.Sc.||MD Anderson Cancer Centre|