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.
Name: Ixazomib
Description: Dose Escalation Phase Starting Dose: Ixazomib 3.0 mg on Days 1, 8, and 15 of a 28-day cycle. Dose Expansion Phase: Maximum tolerated dose from Dose Escalation PhaseType: DrugDose Escalation Group - Ixazomib + Erlotinib Dose Expansion Group - Non Small Cell Lung Cancer Dose Expansion Group - Pancreatic Ductal Adenocarcinoma
Name: Erlotinib
Description: Dose Escalation and Dose Expansion Phase: Erlotinib 150 mg by mouth on Days 1 - 28 of a 29 day cycle.Type: DrugDose Escalation Group - Ixazomib + Erlotinib Dose Expansion Group - Non Small Cell Lung Cancer Dose Expansion Group - Pancreatic Ductal Adenocarcinoma
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 daysDescription: 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 weeksDescription: 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 weeksAllocation: Non-Randomized
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 ---