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A Phase II, Randomized, Open Label Study of Single Dose siG12D LODER in Combination With Chemotherapy in Patients With Unresectable Locally Advanced Pancreatic Cancer

Phase 2
18 Years
Not Enrolling
Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer

Thank you

Trial Information

A Phase II, Randomized, Open Label Study of Single Dose siG12D LODER in Combination With Chemotherapy in Patients With Unresectable Locally Advanced Pancreatic Cancer

In this Phase II study a single dose 3,000µg (eight 375µg siG12DLODERs) will be administered
to patients with unresectable LAPC combined with chemotherapy treatment (Gemcitabine or
FOLFIRINOX). 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 ony chemotherapy.

The investigational agent siG12D LODER is a miniature biodegradable capsule 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 12 patients, and
results showed a high safety and tolerability profiles, with no single DLT.

Inclusion Criteria:

- Provide written informed consent and be between the ages of 18 and up.

- Have an unresectable, locally advanced diagnosed adenocarcinoma of the pancreas. Or
patients with a tumor who are not planning to undergo surgery due to a high surgical
risk (e.g., coagulopathy or severe congestive heart failure).

- Allocated to receive standard of care chemo as first line treatment in accordance
with treating physician recommendation.

- Have a target tumor that is accessible for intratumoral administration by PTA or EUS
guidance as determined by the radiologist/gastroenterologist performing the PTA/EUS

- Have an ECOG performance status of ≤ 1

- Have a life expectancy of ≥ 3 months.

- If female and of child-bearing potential, have a negative serum pregnancy test during

- 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< 2.0 mg/dL, INR < 1.5, absolute neutrophil count (ANC) > 1,000
x 103 cells/mL, platelets ≥ 75,000/mL, and hemoglobin ≥ 10 mg/dL.

- Have screening procedures completed within 4 weeks of starting treatment.

- No other malignancy present that would interfere with the current intervention.

- Have measurable disease. Patients must have clinically and/or radiographically
documented measurable disease. At least one site of disease must be unidimensionally
measurable as follows:

CT-scan {> 10 mm} Lymph node short axis{ > 15 mm}

All radiology studies must be performed within 28 days prior to registration (35 days if

Exclusion Criteria:

- New York Heart Association (NYHA) Class III or IV, cardiac disease,myocardial
infarction within 6 months prior to Day 1, unstable arrhythmia or symptomatic
peripheral arterial vascular disease

- Known brain, leptomeningeal or epidural metastases (unless treated and well
controlled for at least 3 months) or any other metastases

- 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 5 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

- Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1, without
complete recovery

- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic

- Treatment of pancreatic cancer with surgery or radiation therapy prior to study entry

- Prior therapy with an hypoxic cytotoxin

- Subjects who participated in an investigational drug or device study within 28 days
prior to study entry

- Known 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS) in the study population

Outcome Time Frame:

One year

Safety Issue:


Principal Investigator

Ayala Hubert, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hadassah Medical Center


Israel: Ethics Commission

Study ID:




Start Date:

September 2012

Completion Date:

December 2014

Related Keywords:

  • Pancreatic Ductal Adenocarcinoma
  • Pancreatic Cancer
  • siRNA
  • RNA interference (RNAi)
  • Cancer
  • Pancreatic ductal adenocarcinoma
  • Locally Advanced Pancreatic cancer
  • Solid tumor
  • Non operable pancreatic ductal adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms
  • Carcinoma, Ductal, Breast