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Pancreatic Ductal AdenocarcinomaPhase 2PROTACTNCT01676259

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

A Phase 2 study testing siG12D-LODER, Gemcitabine+nab-Paclitaxel and Folfirinox in people with Pancreatic Ductal Adenocarcinoma and Pancreatic Cancer, run by Silenseed Ltd at 9 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
siG12D-LODER, Gemcitabine+nab-Paclitaxel and Folfirinox
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
9 sitesin 2 countries
Study dates
7 Mar 2018to Aug 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • 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.
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  • 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
  • hemoglobin ≥ 9 mg/dL
  • alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 5 times upper limit of normal (ULN)
  • bilirubin ≤ 1.5 x ULN Sex
  • 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.
  • Women of childbearing potential (WOCBP): a negative serum or urine pregnancy test during screening.
  • 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
  • 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.

Who cannot join

  • 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).
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  • 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.
  • Prior/Concomitant Therapy
  • 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 cytotoxic agent (hypoxia-targeting drugs). Prior/Concurrent Clinical Study Experience
  • 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:
  • Unwillingness or inability to comply with the study protocol for any reason.
  • Known allergy to sesame oil.

Trial locations and contacts

9 sites in 2 countries.

Orit Pollack-Shragai, MSc, MBA contact

+972-52-8466267

orit@silenseed.com

9 sites in 2 countries

Israel5 sites, 3 recruiting

  • Rambam Medical Center

    Haifa, 3525408

    Valerya Semenysty, MD, +972-4-7776419, semenysty@rambam.health.gov.il

    Iyad Khamaysi, MD, +972-4-7773626, z_khamaysi@rambam.health.gov.ill

    Recruiting

  • Rabin Medical Center

    Petah Tikva, 49102

    Completed

  • Sheba Medical Center (Tel H'shomer)

    Ramat Gan, 52621

    Talia Golan, MD, +972-3-5305338, Talia.Golan@sheba.health.gov.il

    Maor Lahav, MD, +972- 3-5305875, Maor.Lahav@sheba.health.gov.il

    Recruiting

  • Sourasky MC (Ichilov) Tel Aviv Israel

    Tel Aviv

    Ravit Geva, M.D, 972- 36973082, ravitg@tlvmc.gov.il

    Adam Phillips, M.D, adamp@tlvmc.gov.il

    Recruiting

  • Assaf Harofeh Medical Center

    Tzrifin, 70300

    Active, not recruiting

Other trials in Israel

United States4 sites, 3 recruiting

  • Hackensack Meridian Health

    Hackensack, New Jersey, 07601

    Active, not recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Milind Javle, MD, 713-792-5434, mjavle@mdanderson.org

    Manoop Bhutani, MD, 1-713-792-2121, Manoop.Bhutani@mdanderson.org

    Recruiting

  • The Mount Sinai Hospital

    New York, New York, 10029

    Celina Ang, MD, 212-824-8551, celina.ang@mssm.edu

    Christopher DiMaio, MD, 212-241-7531, christopher.dimaio@mountsinai.org

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Eileen M O'Reilly, MD, 646-888-4182, oreillye@mskcc.org

    Anna M Varghese, MD, 646-888-4308, VarghesA@mskcc.org

    Recruiting

Other trials in United States

About this study

Official title: A Prospective, Multinational, Multi-Center, Phase 2, Single-Arm, Open-Label Study Evaluating the Efficacy, Safety and Tolerability of siG12D-LODER in Combination With Standard of Care Chemotherapy in the Treatment of 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.
Read the detailed 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.

Being tested
siG12D-LODER, Gemcitabine+nab-Paclitaxel, Folfirinox
Keywords
siRNA, RNA interference (RNAi), Cancer, Pancreatic ductal adenocarcinoma, Locally Advanced Pancreatic cancer, Solid tumor, Non operable pancreatic ductal adenocarcinoma, Borderline resectable
Medical subject headings
Pancreatic Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • siG12D-LODERDrug

    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-PaclitaxelDrug

    Also called Chemotherapy

    Gemcitabine+nab-Paclitaxel

  • FolfirinoxDrug

    Also called Chemotherapy

    Folfirinox or modified Folfirinox

Study groups in NCT01676259
Study groupRoleWhat they receive
siG12D-LODER + chemotherapyExperimentalEight siG12D-LODER+Gemcitabine+nab-Paclitaxel or Eight siG12D-LODER+Folfirinox or Eight siG12D-LODER+modifide Folfirinox
Receives: Drug: siG12D-LODER; Drug: Gemcitabine+nab-Paclitaxel; Drug: Folfirinox

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR at 6 months

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2012 (estimated)
  2. Study start7 Mar 2018
  3. Primary completionOct 2022 (estimated)
  4. Study completionAug 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01676259
Sponsor's protocol ID
SLSG12D-P2
Acronym
PROTACT
Status last verified
Jun 2021
First submitted
28 Aug 2012
Last updated
2 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing siG12D-LODER, Gemcitabine+nab-Paclitaxel and Folfirinox in people with Pancreatic Ductal Adenocarcinoma and Pancreatic Cancer, run by Silenseed Ltd at 9 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Israel, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Orit Pollack-Shragai, MSc, MBA (+972-52-8466267, orit@silenseed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR at 6 months (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01676259.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2021; AzTrials last refreshed its copy on 29 Oct 2026.

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