A Phase 2 Study of siG12D LODER in Combination With Chemotherapy in Patients With Locally Advanced Pancreatic Cancer (PROTACT)
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|ClinicalTrials.gov Identifier: NCT01676259|
Recruitment Status : Recruiting
First Posted : August 30, 2012
Last Update Posted : June 8, 2018
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 locally advanced pancreatic cancer combined with chemotherapy treatment.
- Progression-free survival (PFS) in the study population.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Ductal Adenocarcinoma Pancreatic Cancer||Drug: siG12D-LODER Drug: Gemcitabine+nab-Paclitaxel||Phase 2|
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 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, and 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 high safety and tolerability profiles, with no single DLT.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study Evaluating the Efficacy,Safety,Tolerability and PK of siG12D-LODER in the Treatment of Patients With Unresectable LAPC When Used in Conjunction With Standard Chemotherapy (Gemcitabine+Nab-Paclitaxel) Versus Chemotherapy Alone|
|Actual Study Start Date :||March 7, 2018|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||June 2020|
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.
Other Name: Chemotherapy
- Progression-free survival (PFS) in the study population [ Time Frame: One year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01676259
|Contact: Adi Slilat Weiss, MScfirstname.lastname@example.org|
|United States, New Jersey|
|Hackensack Meridian Health||Recruiting|
|Hackensack, New Jersey, United States, 07601|
|Contact: Martin Gutierrez, MD 551-996-5863 Martin.Gutierrez@hackensackmeridian.org|
|Principal Investigator: Martin Gutierrez, MD|
|Principal Investigator: Rosario Ligresti, MD|
|United States, New York|
|The Mount Sinai Hospital||Recruiting|
|New York, New York, United States, 10029|
|Contact: Christopher J DiMaio, MD 212-241-7535 Christopher.DiMaio@mountsinai.org|
|Principal Investigator: Christopher J DiMaio, MD|
|Principal Investigator: Celina Ang, MD|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Eileen M O'Reilly, MD 646-888-4182 email@example.com|
|Principal Investigator: Eileen M. O'Reilly, MD|
|Principal Investigator: Mark A. Schattner, MD|
|Principal Investigator: Anna M. Varghese, MD|
|Principal Investigator:||Eileen M O'Reilly, MD||Memorial Sloan Kettering Cancer Center|
|Principal Investigator:||Talia Golan, MD||Sheba Medical Center|