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A Phase Ib Clinical Study of BBI608 in Combination with Standard Chemotherapies in Adult Patients with Metastatic Pancreatic Adenocarcinoma

Primary: To determine the safety, tolerability and the RP2D of BBI608 when administered in combination with Gemcitabine and nab-Paclitaxel, mFOLFIRINOX, FOLFIRI, or MM-398 with 5-FU and leucovorin in adult patients with metastatic pancreatic ductal adenocarcinoma. Secondary: To determine the pharmacokinetic profile of BBI608 administered in combination with Gemcitabine and nab-Paclitaxel, mFOLFIRINOX, FOLFIRI, or MM-398 with 5-FU and leucovorin. To determine the pharmacodynamics (i.e., identify biomarkers) of BBI608 administered in combination with Gemcitabine and nab-Paclitaxel, mFOLFIRINOX, FOLFIRI, or MM-398 with 5-FU and leucovorin. To determine the preliminary anti-tumor activity of BBI608 when administered in combination with Gemcitabine and nab-Paclitaxel, mFOLFIRINOX, FOLFIRI, or MM-398 with 5-FU and leucovorin in adult patients with metastatic pancreatic ductal adenocarcinoma.

Primary: To determine the safety, tolerability and the RP2D of BBI608 when administered in combination with Gemcitabine and nab-Paclitaxel, mFOLFIRINOX, FOLFIRI, or MM-398 with 5-FU and leucovorin in adult patients with metastatic pancreatic ductal adenocarcinoma. Secondary: To determine the pharmacokinetic profile of BBI608 administered in combination with Gemcitabine and nab-Paclitaxel, mFOLFIRINOX, FOLFIRI, or MM-398 with 5-FU and leucovorin. To determine the pharmacodynamics (i.e., identify biomarkers) of BBI608 administered in combination with Gemcitabine and nab-Paclitaxel, mFOLFIRINOX, FOLFIRI, or MM-398 with 5-FU and leucovorin. To determine the preliminary anti-tumor activity of BBI608 when administered in combination with Gemcitabine and nab-Paclitaxel, mFOLFIRINOX, FOLFIRI, or MM-398 with 5-FU and leucovorin in adult patients with metastatic pancreatic ductal adenocarcinoma.