A Phase II Study of siG12D LODER in Combination With Chemotherapy in Patients With Unresectable Locally Advanced Pancreatic Cancer
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.
- Progression-free survival (PFS) in the study population.
Pancreatic Ductal Adenocarcinoma
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II, Randomized, Open Label Study of Single Dose siG12D LODER in Combination With Chemotherapy in Patients With Unresectable Locally Advanced Pancreatic Cancer|
- Progression-free survival (PFS) in the study population [ Time Frame: One year ] [ Designated as safety issue: No ]
|Study Start Date:||February 2017|
|Estimated Study Completion Date:||June 2020|
|Estimated Primary Completion Date:||February 2019 (Final data collection date for primary outcome measure)|
Active Comparator: Chemotherapy
Other Name: Chemotherapy
Experimental: siG12D-LODER + chemotherapy
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676259
|Contact: Sofia Muravnik||+972-8-6286005||Sofia@silenseed.com|
|Shaare Zedek Medical Center|
|Jerusalem, Israel, 91031|
|Hadassah Medical Organization|
|Jerusalem, Israel, 91120|
|Sheba Medical Center|
|Ramat Gan, Israel, 52621|
|Principal Investigator:||Ayala Hubert, MD||Hadassah Medical Center|
|Principal Investigator:||Talia Golan, MD||Sheba Medical Center|
|Principal Investigator:||Amiel Segal, MD||Shaare Zedek Medical Center|