Pancreatic Cancer Tyme-88-PANC

A prospective, open-label phase 2 trial in metastatic pancreatic cancer subjects who have failed at least one line of any prior chemotherapy. The trial is designed to evaluate the of SM-88 therapy on pancreatic cancer and will measure multiple efficacy and safety endpoints, including overall response rate, overall survival, progression free survival, relevant biomarkers, quality of life and safety. In the initial stage of the trial (36 subjects), two dose levels of SM-88's metyrosine-derivative will be evaluated.

Eligibility Criteria:

1. Biopsy-proven metastatic pancreatic adenocarcinoma with documented radiographic disease progression on or after one or more systemic therapies. Chemotherapy given as part of prior chemoradiation in the setting of non-metastatic pancreatic cancer does not count as a line of therapy. Chemotherapy given for at least 4 months as adjuvant after complete response is considered as a first line therapy.
2. Subjects must be unwilling or unable to tolerate other non-study systemic chemotherapy.
3. Subjects must have measurable lesions (according to standard RECIST 1.1).
4. Subjects must have completed systemic therapy at least 28 days prior to first dose.

This study is for patients age 18 and older.

Available at: Hospital of Central Connecticut