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

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ClinicalTrials.gov Identifier: NCT01676259
Recruitment Status : Recruiting
First Posted : August 30, 2012
Last Update Posted : February 6, 2018
Information provided by (Responsible Party):
Silenseed Ltd

Brief Summary:

In this Phase II study a single dose 2.8 mg (eight 0.35 mg siG12D-LODERs) will be administered to patients with unresectable locally advanced pancreatic cancer combined with chemotherapy treatment.

Primary Outcome:

- Progression-free survival (PFS) in the study population.

Condition or disease Intervention/treatment Phase
Pancreatic Ductal Adenocarcinoma Pancreatic Cancer Drug: siG12D-LODER Drug: Gemcitabine+nab-Paclitaxel Phase 2

Detailed Description:

In this Phase II study a single dose 2.8 mg (eight 0.35 mg siG12D-LODERs) will be administered to patients with unresectable LAPC combined with chemotherapy treatment (Gemcitabine+nab-Paclitaxel). This will be the first study to assess the response rate of the siG12D-LODER in patients with unresectable LAPC. The study is of a two-arm design with one arm receiving siG12D-LODER + chemotherapy, while the other arm receiving only 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 a high safety and tolerability profiles, with no single DLT.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study Evaluating the Efficacy,Safety,Tolerability and PK of siG12D-LODER in the Treatment of Patients With Unresectable LAPC When Used in Conjunction With Standard Chemotherapy (Gemcitabine+Nab-Paclitaxel) Versus Chemotherapy Alone
Anticipated Study Start Date : February 6, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Chemotherapy
Drug: Gemcitabine+nab-Paclitaxel
Other Name: Chemotherapy
Experimental: siG12D-LODER + chemotherapy
Eight siG12D-LODER+(Gemcitabine+nab-Paclitaxel)
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
Other Name: Chemotherapy

Primary Outcome Measures :
  1. Progression-free survival (PFS) in the study population [ Time Frame: One year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects who provide written informed consent to participate in the study
  • Men and women patients 18 years of age and up
  • Have an unresectable, locally advanced pancreatic cancer (AJCC stage III). (Excluded: resectable and borderline resectable patients are ineligible per NCCN criteria)
  • Allocated to receive Gemcitabine + nab-Paclitaxel as first line treatment.
  • Have a target tumor that is accessible for intratumoral administration by PTA (Percutaneous transluminal approach) or EUS (Endoscopic Ultrasound) guidance as determined by the radiologist/gastroenterologist performing the PTA/EUS injection.
  • Have an ECOG performance status of ≤ 1
  • If female and of childbearing potential, have a negative serum or urine pregnancy test during screening. Agree to use a barrier method of contraception if sexually active (both men and women) from the time of administration of the first treatment and for at least 8 weeks after treatment.
  • Have serum creatinine <1.6 mg/dL, INR < 1.5 U, absolute neutrophil count (ANC) > 1 x 109/L , platelets ≥ 100 x 109/L , hemoglobin ≥ 10 mg/dL, ALT and AST ≤ 3 x ULN, bilirubin ≤ 1.5 x ULN
  • Have measurable disease. Patients must have clinically and/or radiographically documented measurable primary disease according to RECIST 1.1. At least one site of disease must be unidimensionally measurable. All radiology scans must be performed within 28 days prior to registration

Exclusion Criteria:

  • 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 nonadenocarcinoma histology.
  • Any prior therapy for the treatment of pancreatic malignancy (including chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major surgery, or irradiation, whether conventional or investigational).
  • Prior therapy with any hypoxic cytotoxin (hypoxia-targeting drugs).
  • 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
  • Severe chronic obstructive or other pulmonary disease with hypoxemia (requires supplementary oxygen, symptoms due to hypoxemia or oxygen saturation <90% by pulse oximetry after a 2 minute walk) or in the opinion of the investigator any physiological state likely to cause systemic or regional hypoxemia
  • History of clinically significant coagulopathy
  • Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1, without complete recovery
  • New York Heart Association (NYHA) Class III or IV, cardiac disease, myocardial infarction within 4months prior to Day 1, unstable arrhythmia or symptomatic peripheral arterial vascular disease
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
  • Subjects who participated in an investigational drug or device study within 28 days prior to study entry
  • Known active infection with 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
  • Unwillingness or inability to comply with the study protocol for any reason
  • Participation in another clinical trial with drugs received within 3 months prior to dosing (calculated from the previous study's last dosing date).

Information from the National Library of Medicine

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): NCT01676259

Contact: Adi Slilat Weiss, MSc +972-8-6286005 adi.slilat@silenseed.com

United States, New Jersey
Hackensack Meridian Health Not yet recruiting
Hackensack, New Jersey, United States, 07601
Contact: Martin Gutierrez, MD    551-996-5863    Martin.Gutierrez@hackensackmeridian.org   
Principal Investigator: Martin Gutierrez, MD         
Principal Investigator: Rosario Ligresti, MD         
United States, New York
The Mount Sinai Hospital Not yet recruiting
New York, New York, United States, 10029
Contact: Christopher J DiMaio, MD    212-241-7535    Christopher.DiMaio@mountsinai.org   
Principal Investigator: Christopher J DiMaio, MD         
Principal Investigator: Celina Ang, MD         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Eileen M O'Reilly, MD    646-888-4182    oreillye@mskcc.org   
Principal Investigator: Eileen M. O'Reilly, MD         
Principal Investigator: Mark A. Schattner, MD         
Principal Investigator: Anna M. Varghese, MD         
United States, Rhode Island
Lifespan Not yet recruiting
Providence, Rhode Island, United States, 02906
Contact: Benedito A Carneiro, MD    844-222-2881    Benedito.Carneiro@Lifespan.org   
Principal Investigator: Howard P Safran, MD         
Principal Investigator: Benedito A Carneiro, MD         
Principal Investigator: Jason D Ferreira, MD         
Sponsors and Collaborators
Silenseed Ltd
Principal Investigator: Eileen M O'Reilly, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Talia Golan, MD Sheba Medical Center

Additional Information:
Responsible Party: Silenseed Ltd
ClinicalTrials.gov Identifier: NCT01676259     History of Changes
Other Study ID Numbers: SLSG12D-P2
First Posted: August 30, 2012    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Silenseed Ltd:
RNA interference (RNAi)
Pancreatic ductal adenocarcinoma
Locally Advanced Pancreatic cancer
Solid tumor
Non operable pancreatic ductal adenocarcinoma

Additional relevant MeSH terms:
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs