At a glance
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A Phase I/II Study of Indoximod in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Metastatic Adenocarcinoma of the Pancreas
In Brief
A Phase 2 clinical trial evaluating Nab-Paclitaxel, Gemcitabine, and 1 other intervention for Metastatic Pancreatic Adenocarcinoma and Metastatic Pancreatic Cancer. Completed, enrolled 157 participants across 11 sites.
Detailed Summary
This phase I/II trial is designed to efficiently identify the regimen limiting toxicity (RLT) and recommended phase 2 dose (RP2D) for the combination of the immunotherapeutic agent indoximod when administered in combination with standard of care chemotherapy gemcitabine plus nab-paclitaxel in subjects with metastatic adenocarcinoma of the pancreas. All subjects will receive the same standard gemcitabine plus nab-paclitaxel regimen, plus indoximod in doses increasing from 600 mg twice daily to, potentially, 1200 mg twice daily.
Study Details
Timeline
Interventions
Nab-Paclitaxel 125 mg/m\^2 given intravenously over 30-40 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity.
Gemcitabine 1000 mg/m\^2 given intravenously over 30 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity.
Indoximod administered BID by mouth in the form of 200 mg capsules. The medication should be taken twice daily for 28 days each cycle. Patients will continue until they experience disease progression or toxicity.