Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01676259
Other study ID # SLSG12D-P2
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 7, 2018
Est. completion date August 2023

Study information

Verified date June 2021
Source Silenseed Ltd
Contact Orit Pollack-Shragai, MSc, MBA
Phone +972-52-8466267
Email orit@silenseed.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date August 2023
Est. primary completion date October 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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.
Gemcitabine+nab-Paclitaxel
Gemcitabine+nab-Paclitaxel
Folfirinox
Folfirinox or modified Folfirinox

Locations

Country Name City State
Israel Rambam Medical Center Haifa
Israel Rabin Medical Center Petah Tikva
Israel Sheba Medical Center (Tel H'shomer) Ramat Gan
Israel Sourasky MC (Ichilov) Tel Aviv Israel Tel Aviv
Israel Assaf Harofeh Medical Center Tzrifin
United States Hackensack Meridian Health Hackensack New Jersey
United States MD Anderson Cancer Center Houston Texas
United States Memorial Sloan Kettering Cancer Center New York New York
United States The Mount Sinai Hospital New York New York

Sponsors (1)

Lead Sponsor Collaborator
Silenseed Ltd

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary ORR at 6 months One year
See also
  Status Clinical Trial Phase
Completed NCT05305001 - Germline Mutations Associated With Hereditary Pancreatic Cancer in Unselected Patients With Pancreatic Cancer in Mexico
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Recruiting NCT05497531 - Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers N/A
Recruiting NCT04927780 - Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer Phase 3
Recruiting NCT06054984 - TCR-T Cells in the Treatment of Advanced Pancreatic Cancer Early Phase 1
Recruiting NCT05919537 - Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation Phase 1
Terminated NCT03140670 - Maintenance Rucaparib in BRCA1, BRCA2 or PALB2 Mutated Pancreatic Cancer That Has Not Progressed on Platinum-based Therapy Phase 2
Terminated NCT00529113 - Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer Phase 1
Recruiting NCT05168527 - The First Line Treatment of Fruquintinib Combined With Albumin Paclitaxel and Gemcitabine in Pancreatic Cancer Patients Phase 2
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Recruiting NCT05391126 - GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care N/A
Terminated NCT03300921 - A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer Phase 1
Completed NCT03153410 - Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas Early Phase 1
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Recruiting NCT05679583 - Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer Phase 2
Recruiting NCT04183478 - The Efficacy and Safety of K-001 in the Treatment of Advanced Pancreatic Cancer Phase 2/Phase 3
Terminated NCT03600623 - Folfirinox or Gemcitabine-Nab Paclitaxel Followed by Stereotactic Body Radiotherapy for Locally Advanced Pancreatic Cancer Early Phase 1
Recruiting NCT04584008 - Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics N/A
Recruiting NCT05351983 - Patient-derived Organoids Drug Screen in Pancreatic Cancer N/A
Completed NCT04290364 - Early Palliative Care in Pancreatic Cancer - a Quasi-experimental Study

External Links