A Phase 2 Study of siG12D LODER in Combination With Chemotherapy in Patients With Locally Advance… (NCT01676259) | Clinical Trial Compass
UnknownPhase 2
A Phase 2 Study of siG12D LODER in Combination With Chemotherapy in Patients With Locally Advanced Pancreatic Cancer
United States, Israel80 participantsStarted 2018-03-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically or cytologically confirmed adenocarcinoma of the pancreas.
✓. Locally advanced pancreatic cancer stage III according to The American Joint Committee on Cancer (AJCC) and defined as T4, N (any) and M0, according to the three factors, T (tumor), N (node involvement), and M (metastases), of the National Comprehensive Cancer Network TNM classification.
✓. Allocated to receive one of the following chemotherapies: gemcitabine plus nab-paclitaxel, FOLFIRINOX or modified FOLFIRIONOX as first line treatment for pancreatic cancer.
✓. Have a target tumor that is accessible for intratumoral administration by EUS as determined by the radiologist/gastroenterologist performing the EUS intratumoral administration, according to The American Society for Gastrointestinal Endoscopy (ASGE) guidelines (https://www.asge.org/home/practice-support/guidelines).
✓. Have measurable disease. Subject will have a histologically-confirmed disease and must have clinically and/or radiographically documented measurable primary disease according to RECIST v1.1. At least one site of disease must be unidimensionally measurable.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Scale of ≤ 1.
✓. Demonstrate adequate organ function as defined below:
✓. Male and/or female. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
✕. Other malignancy that would interfere with the current intervention.
✕. Any evidence of ascites (beyond trace).
✕. Bulky celiac adenopathy (≥2.5 cm) or non-adenocarcinoma histology.
✕. Previously treated malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancers from which the subject has been disease-free for at least 2 years.
✕. History of clinically significant coagulopathy.
✕. Major surgery, other than diagnostic surgery, within 4 weeks prior to study entry without complete recovery.