Solid Tumors Clinical Trial
Official title:
A Phase I Study of Ixazomib and Erlotinib in Advanced Solid Tumor Patients
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.
Study Groups: If you are found to be eligible to take part in this study, you will be assigned to a dose level of ixazomib and erlotinib based on when you join this study. Up to 4 dose levels of ixazomib will be tested. Up to 18 participants may be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of ixazomib is found. All participants will receive the same dose of erlotinib. Once the highest tolerable dose is found, up to 18 participants will be enrolled at that dose level as an expansion group. The dose of the study drug combination that you receive may be lowered if you have intolerable side effects. Study Drug Administration Each study cycle is 28 days. You will take ixazomib capsules by mouth on Days 1, 8, and 15 of each cycle. You will take erlotinib tablets by mouth on Days 1-28 of each cycle. You should swallow ixazomib capsules whole with 8 ounces (1 cup) of water. Each capsule should be swallowed separately with a sip of water. You should also swallow erlotinib tablets whole with water. You should take the ixazomib and erlotinib doses at the same time. Do not break, chew, or open the capsules or tablets. Each dose should be taken on an empty stomach, at least 1 hour before or 2 hours after a meal. If you miss a dose, take it as soon as you remember, as long as the next scheduled dose is at least 72 hours (ixazomib) or 12 hours (erlotinib) away. You should not take a double dose to make up for a missed dose. If you vomit after taking a dose, wait until the next scheduled dose. Do not take an additional dose. Your dose of study drug may be changed and/or you may be given drugs to help control the side effects. Study Visits: Cycle 1: Week 1: - You will have a physical exam. - Blood (about 6 teaspoons) will be drawn for routine tests and to check your liver and kidney function. - If you can become pregnant, leftover blood (about 1 teaspoon) and/or urine will be collected for a pregnancy test. - During Days 1, 2, 3, 5, and 8, blood (about 1-3 teaspoons) will be drawn for pharmacokinetic (PK) testing. PK testing measures the amount of study drug in the body at different time points. Week 2: °Blood (about 6 teaspoons) will be drawn for routine tests and to check your liver and kidney function. Week 3: - You will have a physical exam. - Blood (about 6 teaspoons) will be drawn for routine tests and to check your liver and kidney function. Cycle 2 and Beyond: Week 1: - You will have a physical exam. - Blood (about 6 teaspoons) and urine will be collected for routine tests. The blood sample will also be used for liver and kidney function tests. - If you can become pregnant, part of the routine blood or urine test will be used for a pregnancy test. To continue on this study, you must not be pregnant. Week 4: - You will have a physical exam. - Blood (about 6 teaspoons) will be drawn for routine tests and to check your liver and kidney function. - On Day 28 of each cycle, if the doctor thinks it is needed, you will have an EKG. - At the end of every other cycle (Cycles 2, 4, 6, and so on), you will have imaging scans (either CT scans or MRI) performed to check the status of the disease. If you have side effects or abnormal test results while on study, you may be asked to return to the clinic for more tests until the side effects or abnormal test results improve. Length of Study: You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, if you develop new health problems, or if you are no longer able to follow study directions. Your participation on the study will be over after the end-of-study visit. End of Study Visit: Within 30 days after your last dose of the study drugs, the following tests and procedures will be performed: - You will have a physical exam. - Blood (about 6 teaspoons) will be drawn for routine tests and to check your liver and kidney function. - Urine will be collected for routine tests. ;
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