MedTrace Logo

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

NCT01676259 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-07-02

No results posted yet for this study

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

Interventions

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

Gemcitabine+nab-Paclitaxel

DRUG

Folfirinox

Folfirinox or modified Folfirinox

Sponsors & Collaborators

  • Silenseed Ltd

    lead INDUSTRY

Principal Investigators

  • Eileen M O'Reilly, MD · Memorial Sloan Kettering Cancer Center

  • Talia Golan, MD · Sheba Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-07
Primary Completion
2022-10-31
Completion
2023-08-31
FDA Drug
Yes

Countries

  • United States
  • Israel

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01676259 on ClinicalTrials.gov