Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Phase I - Escalating Dose Study of siG12D LODER (Local Drug EluteR) in Patients With Locally Advanced Adenocarcinoma of the Pancreas, and a Single Dose Study of siG12D LODER (Local Drug EluteR) in Patients With Non-operable Adenocarcinoma of the Pancreas

Lead Sponsor:

Silenseed Ltd

Conditions:

Pancreatic Ductal Adenocarcinoma

Pancreatic Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

Phase 0 - Open label, Single dose study of siG12D LODER in Patients with operable adenocarcinoma of the pancreas. The primary endpoint: To assess efficacy and local distribution of siRNA out of eigh...

Detailed Description

The investigational agent siG12D LODER (Local Drug EluteR) is a miniature biodegradable polymeric matrix that encompasses anti KRASG12D siRNA (siG12D) drug, designed to release the drug regionally wit...

Eligibility Criteria

Inclusion

  • Phase 0:
  • Provide written informed consent and be between the ages of 18 and up, inclusive.
  • Patient that is diagnosed as respectable locally pancreatic tumor
  • Have a target tumor accessible for intratumoral administration by EUS (Endoscopic Ultrasound) guidance as determined by the physician performing the EUS guided LODER insertion.
  • Have a Karnofsky performance status of ≥ 70%.
  • Have a life expectancy of \>= 3 months.
  • If female and of child-bearing potential, have a negative serum pregnancy test during screening.
  • Agree to use of 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, , PT, - 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 2 weeks of starting treatment.
  • No other malignancy present that would interfere with the current intervention.
  • Have measurable disease.
  • Phase I
  • Provide written informed consent and be between the ages of 18 and up.
  • Have an unresectable, locally advanced diagnosed or highly suspected adenocarcinoma of the pancreas. Or patients with a tumor and are not planed 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.
  • 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 injection.
  • Have a Karnofsky performance status of ≥ 70%.
  • Have a life expectancy of \>= 3 months.
  • If female and of child-bearing potential, have a negative serum pregnancy test during screening.
  • Agree to use of 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, PT - 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.

Exclusion

  • Phase 0:
  • Have distant metastasis spread (such as liver or lung, or lymph nodes metastases), peritoneal spread or malignant sites.
  • Have clinically significant pancreatitis within 12 weeks of treatment.
  • If female, be breast feeding.
  • Have a medical condition contraindicated for both percutaneous- and endoscopic- guided delivery or any intercurrent medical illness or other medical condition that would in the judgment of the investigator compromise patient safety or the objectives of the study.
  • Have a history of bleeding coagulopathy.
  • Have participated in any therapeutic research study within the last 4 weeks.
  • Phase I:
  • Have distant metastatic spread (such as liver, lung, or lymph nodes metastases), peritoneal spread or malignant sites.
  • Have clinically significant pancreatitis within 12 weeks of treatment.
  • If female, be breast feeding.
  • Have a medical condition contraindicated for both percutaneous- and endoscopic- guided delivery or any intercurrent medical illness or other medical condition that would in the judgment of the investigator compromise patient safety or the objectives of the study.
  • Have a history of bleeding coagulopathy.
  • Have participated in any therapeutic research study within the last 4 weeks.

Key Trial Info

Start Date :

January 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2013

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT01188785

Start Date

January 1 2011

End Date

December 1 2013

Last Update

April 9 2019

Active Locations (3)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (3 locations)

1

Shaare Zedek Medical Center

Jerusalem, Israel, 91031

2

Hadassah Medical Organization

Jerusalem, Israel, 91120

3

Sheba Medical Center

Ramat Gan, Israel, 52621