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Pancreatic Neoplasm clinical trials

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NCT ID: NCT03310632 Active, not recruiting - Pancreatic Neoplasm Clinical Trials

Determine Function of Antroquinonol in Combination With SOC in First Line Metastatic Pancreatic Cancer

Start date: December 1, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Antroquinonol is proposed for the treatment of neoplasms. The proposed clinical trial is a Phase I/II study designed to evaluate antroquinonol in combination with nab-paclitaxel and gemcitabine in first line treatment naïve subjects with Stage IV metastatic pancreatic carcinoma. The first part of study will focus on the treatment of pancreatic cancer with 200 mg TID and 300 mg TID, clinical treatment duration of 4 weeks, to determine the MTD or MFD (based on PK and capsules strength) of antroquinonol in combination with a standard dose regimen of nab-paclitaxel and gemcitabine. The extended Phase II will focus on the efficacy of antroquinonol with SOC. Safety and pharmacokinetic profiles will be studied in the proposed clinical trial.