Spots Global Cancer Trial Database for Study of Nintedanib and Chemotherapy for Advanced Pancreatic Cancer

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Trial Identification

Brief Title: Study of Nintedanib and Chemotherapy for Advanced Pancreatic Cancer

Official Title: A Phase 1b and Pharmacodynamic Study of Nintedanib Monotherapy for Advanced Pancreatic Cancer

Study ID: NCT02902484

Conditions

Cancer of Pancreas

Interventions

Nintedanib

Study Description

Brief Summary: The study will perform a clinical study evaluating the safety and tolerability of nintedanib when combined with standard chemotherapy (Gemcitabine + nab-Paclitaxel) for metastatic pancreatic cancer. It will utilize advanced imaging correlates including dynamic contrast enhanced Magnetic Resonance Imaging (DCE-MRI) which correlates with tumor grade and microvessel density.

Detailed Description: Preclinical data suggest nintedanib inhibits primary tumor growth in in vivo xenograft models of pancreatic cancer, as well as inhibiting metastasis in pancreatic cancer models. This effect appears primarily due to nintedanib anti-angiogenic properties. The study will perform a clinical study evaluating the safety and tolerability of nintedanib when combined with standard chemotherapy (Gemcitabine + nab-Paclitaxel) for metastatic pancreatic cancer. It will utilize advanced imaging correlates including dynamic contrast enhanced Magnetic Resonance Imaging (DCE-MRI) which correlates with tumor grade and microvessel density. For each patient, treatment will have two phases: nintedanib monotherapy for a two week period (Days 1-14) followed by combination phase of nintedanib plus chemotherapy (Cycle 2+).