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Clinical Trial Record

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A Phase 2 Study of siG12D LODER in Combination With Chemotherapy in Patients With Locally Advanced Pancreatic Cancer

2018-03-07

2022-10

2023-08

80

Study Overview

A Phase 2 Study of siG12D LODER in Combination With Chemotherapy in Patients With Locally Advanced Pancreatic Cancer

In this Phase II study a dose of 2.8 mg (eight 0.35 mg siG12D-LODERs) will be administered in 12-week cycles to patients with unresectable or borderline resectable locally advanced pancreatic cancer combined with chemotherapy treatment. Primary Outcome: - ORR at 6 months.

In this Phase II study a dose of 2.8 mg (eight 0.35 mg siG12D-LODERs) will be administered in 12-week cycles to patients with unresectable or borderline resectable LAPC combined with chemotherapy treatment (Gemcitabine+nab-Paclitaxel or Folfirinox or modified Folfirinox). This will be a study to assess the response rate of the siG12D-LODER in patients with unresectable or borderline resectable LAPC. The study is of a single arm design with one arm receiving siG12D-LODER + chemotherapy. The investigational agent siG12D-LODER is a miniature biodegradable bio polymeric matrix that encompasses the drug, designed and produced by Silenseed Ltd. The implantation of LODERs is selected to meet current gastroenterology endoscopic ultrasound (EUS) biopsy procedures, proved to be highly effective and safe. siG12D-LODER has been studied in the escalating dose Phase I study of 15 patients, and results showed high safety and tolerability profiles, with no single DLT.

  • Pancreatic Ductal Adenocarcinoma
  • Pancreatic Cancer
  • DRUG: siG12D-LODER
  • DRUG: Gemcitabine+nab-Paclitaxel
  • DRUG: Folfirinox
  • SLSG12D-P2

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2012-08-28  

N/A  

2021-06-30  

2012-08-29  

N/A  

2021-07-02  

2012-08-30  

N/A  

2021-06  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: siG12D-LODER + chemotherapy

Eight siG12D-LODER+Gemcitabine+nab-Paclitaxel or Eight siG12D-LODER+Folfirinox or Eight siG12D-LODER+modifide Folfirinox

DRUG: siG12D-LODER

  • The implantation of siG12D-LODERs is selected to meet current gastroenterology endoscopic ultrasound (EUS) biopsy procedures, proved to be highly effective and safe.

DRUG: Gemcitabine+nab-Paclitaxel

  • Gemcitabine+nab-Paclitaxel

DRUG: Folfirinox

  • Folfirinox or modified Folfirinox
Primary Outcome MeasuresMeasure DescriptionTime Frame
ORR at 6 monthsOne year
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Orit Pollack-Shragai, MSc, MBA

Phone Number: +972-52-8466267

Email: orit@silenseed.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    Age
    1. Subject must be 18 years of age or older at the time of signing the informed consent.
    Type of Subject and Disease Characteristics
    1. Histologically or cytologically confirmed adenocarcinoma of the pancreas. 2. Locally advanced pancreatic cancer stage III according to The American Joint Committee on Cancer (AJCC) and defined as T4, N (any) and M0, according to the three factors, T (tumor), N (node involvement), and M (metastases), of the National Comprehensive Cancer Network TNM classification. 3. Allocated to receive one of the following chemotherapies: gemcitabine plus nab-paclitaxel, FOLFIRINOX or modified FOLFIRIONOX as first line treatment for pancreatic cancer. 4. Have a target tumor that is accessible for intratumoral administration by EUS as determined by the radiologist/gastroenterologist performing the EUS intratumoral administration, according to The American Society for Gastrointestinal Endoscopy (ASGE) guidelines (https://www.asge.org/home/practice-support/guidelines). 5. Have measurable disease. Subject will have a histologically-confirmed disease and must have clinically and/or radiographically documented measurable primary disease according to RECIST v1.1. At least one site of disease must be unidimensionally measurable.
    Diagnostic Assessments 6. Eastern Cooperative Oncology Group (ECOG) Performance Scale of ≤ 1. 7. Demonstrate adequate organ function as defined below:

  • serum creatinine <1.6 mg/dL
  • international normalized ratio (INR) < 1.5 U
  • absolute neutrophil count (ANC) > 1.5 x 109/L
  • platelets ≥ 100 x 109/L
  • hemoglobin ≥ 9 mg/dL
  • alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 5 times upper limit of normal (ULN)
  • bilirubin ≤ 1.5 x ULN Sex 8. Male and/or female. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 9. Women of childbearing potential (WOCBP): a negative serum or urine pregnancy test during screening. 10. Subject of childbearing potential, if sexually active (both men and women) must agree to use a barrier method of contraception, from the time of administration of the first treatment and for at least 8 weeks after EOT visit day.

    • Informed Consent 11. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    Exclusion Criteria:
    Subjects are excluded from the study if any of the following criteria apply:
    Medical Conditions
    1. Subjects with resectable pancreatic cancer. 2. Evidence of metastatic disease. 3. Other malignancy that would interfere with the current intervention. 4. Any evidence of ascites (beyond trace). 5. Bulky celiac adenopathy (≥2.5 cm) or non-adenocarcinoma histology. 6. Previously treated malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancers from which the subject has been disease-free for at least 2 years. 7. History of clinically significant coagulopathy. 8. Major surgery, other than diagnostic surgery, within 4 weeks prior to study entry without complete recovery. 9. New York Heart Association (NYHA) Class III or IV, cardiac disease, myocardial infarction within 4 months prior to the first chemotherapy cycle Day 1, unstable arrhythmia or symptomatic peripheral arterial vascular disease. 10. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. 11. Known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus. 12. Females who are pregnant or breast-feeding. 13. Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study.
    Prior/Concomitant Therapy 14. Any prior therapy for the treatment of pancreatic malignancy (including chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major surgery, or irradiation, whether conventional or investigational). 15. Prior therapy with any hypoxic cytotoxic agent (hypoxia-targeting drugs). Prior/Concurrent Clinical Study Experience 16. Subjects who are participating or participated in an investigational drug or device study (within 28 days prior to study entry from the last study dose date).
    Other Exclusions: 17. Unwillingness or inability to comply with the study protocol for any reason. 18. Known allergy to sesame oil.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Eileen M O'Reilly, MD, Memorial Sloan Kettering Cancer Center

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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