Full TitleA Prospective, Multinational, Multi-Center, Phase 2, Randomized, Controlled, Open-Label Study Evaluating the Efficacy, Safety, Tolerability and Pharmacokinetics of siG12D-LODER in the Treatment of Patients with Unresectable Locally Advanced Pancreatic Cancer when used in Conjunction with Standard Chemotherapy (Gemcitabine+nab-Paclitaxel) versus Chemotherapy (Gemcitabine+nab-Paclitaxel) alone
The purpose of this study is to assess the safety and effectiveness of a new medication called siG12D-LODER when given with standard chemotherapy (gemcitabine and nab-paclitaxel) as the first treatment for inoperable pancreatic cancer. siG12D-LODER is a small capsule, measuring about a quarter of an inch in length, which releases a drug called siG12D into the tumor over about three months. siG12D-LODER targets and kills tumor cells. The siG12D specifically targets KRAS mutations (genetic alterations), which are common in patients with pancreatic cancer.
siG12D-LODER is inserted directly into the tumor via endoscopy (a tube inserted down the esophagus into the stomach). Guided by endoscopic ultrasound, the doctor inserts siG12D-LODER into the tumor via a needle inserted through the stomach. Doctors insert a new siG12D-LODER capsule every three months until a change in the cancer is observed.
Patients in this study will be randomly assigned to receive siG12D-LODER plus standard chemotherapy, or standard chemotherapy alone (which is given by vein).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have previously untreated inoperable (stage III) pancreatic cancer.
- Patients who receive siG12D-LODER must have tumors that are accessible via endoscopy.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- This study is for patients age 18 and older.
For more information and to inquire about eligibility for this study, please contact Dr. Anna Varghese at 646-888-4308.