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

NCT01676259 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: SLSG12D-P2
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 9

Brief 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.

Conditions

Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer

Keywords

siRNA; RNA interference (RNAi); Cancer; Pancreatic ductal adenocarcinoma; Locally Advanced Pancreatic cancer; Solid tumor; Non operable pancreatic ductal adenocarcinoma; Borderline resectable

Outcome Measures

Primary Outcomes (1)

• ORR at 6 months

  One year

Study Arms (1)

siG12D-LODER + chemotherapy

EXPERIMENTAL

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

Drug: siG12D-LODER; Drug: Gemcitabine+nab-Paclitaxel; Drug: Folfirinox

Interventions

siG12D-LODER DRUG

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

siG12D-LODER + chemotherapy

Gemcitabine+nab-Paclitaxel DRUG

Gemcitabine+nab-Paclitaxel

Also known as: Chemotherapy

siG12D-LODER + chemotherapy

Folfirinox DRUG

Folfirinox or modified Folfirinox

Also known as: Chemotherapy

siG12D-LODER + chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age
• \. Subject must be 18 years of age or older at the time of signing the informed consent.
• Type of Subject and Disease Characteristics
• Histologically or cytologically confirmed adenocarcinoma of the pancreas.
• 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.
• Allocated to receive one of the following chemotherapies: gemcitabine plus nab-paclitaxel, FOLFIRINOX or modified FOLFIRIONOX as first line treatment for pancreatic cancer.
• 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).
• 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
• Eastern Cooperative Oncology Group (ECOG) Performance Scale of ≤ 1.
• 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

You may not qualify if:

• Subjects are excluded from the study if any of the following criteria apply:
• Medical Conditions
• Subjects with resectable pancreatic cancer.
• Evidence of metastatic disease.
• Other malignancy that would interfere with the current intervention.
• Any evidence of ascites (beyond trace).
• Bulky celiac adenopathy (≥2.5 cm) or non-adenocarcinoma histology.
• 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.
• History of clinically significant coagulopathy.
• Major surgery, other than diagnostic surgery, within 4 weeks prior to study entry without complete recovery.
• 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.
• Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
• Known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus.
• Females who are pregnant or breast-feeding.
• 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.

Sponsors & Collaborators

• Silenseed Ltd: lead

Study Sites (9)

Hackensack Meridian Health

Hackensack, New Jersey, 07601, United States

ACTIVE NOT RECRUITING

The Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Rambam Medical Center

Haifa, 3525408, Israel

RECRUITING

Rabin Medical Center

Petah Tikva, 49102, Israel

COMPLETED

Sheba Medical Center (Tel H'shomer)

Ramat Gan, 52621, Israel

RECRUITING

Sourasky MC (Ichilov) Tel Aviv Israel

Tel Aviv, Israel

RECRUITING

Assaf Harofeh Medical Center

Tzrifin, 70300, Israel

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasms

Interventions

Drug Therapy; folfirinox

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Eileen M O'Reilly, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Talia Golan, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Orit Pollack-Shragai, MSc, MBA

CONTACT

+972-52-8466267; orit@silenseed.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2012
• First Posted: August 30, 2012
• Study Start: March 7, 2018
• Primary Completion: October 1, 2022
• Study Completion: August 1, 2023
• Last Updated: July 2, 2021

Record last verified: 2021-06

Locations

US (4); IL (5)