The goal of this clinical research study is to find the highest tolerable dose of the combination of ixazomib and erlotinib that can be given to patients with advanced solid tumors. The safety of these drugs will also be studied. This is an investigational study. Erlotinib is FDA approved and commercially available to treat non-small cell lung cancer, but its use in advanced solid cancer is considered investigational. Ixazomib is FDA approved. The study doctor can explain how the study drugs are designed to work. Up to 36 patients will take part in this study. All will be enrolled at MD Anderson.
Description: MTD defined by dose limiting toxicities (DLTs) that occur during the first cycle. Dose limiting toxicity (DLT) defined as Any Grade 3 or 4 non-hematologic toxicity as defined in the NCI CTCAE. Any Grade 4 hematologic toxicity lasting two weeks or longer (as defined by the NCI-CTCAE), despite supportive care. Grade 4 nausea, vomiting or diarrhea > 5 days despite maximum anti-nausea regimens.Measure: Maximum Tolerated Dose (MTD) of Ixazomib and Erlotinib in Advanced Cancer Participants Time: 28 days
Description: Tumor response of this combination per RECIST version 1.1.Measure: Tumor Response of Ixazomib and Erlotinib in Participants with Non Small Cell Lung Cancer Time: 8 weeks
Description: Tumor response of this combination per RECIST version 1.1.Measure: Tumor Response of Ixazomib and Erlotinib in Participants with Pancreatic Ductal Adenocarcinoma Time: 8 weeks
Single Group Assignment
There is one SNP
erlotinib or afatinib) and tested negative for EGFR T790M mutation. --- T790M ---
We will allow patients with positive EGFR T790M mutation if they have progressed on third generation anti-EGFR therapy (e.g. --- T790M ---