Clinical Study Protocol RTA 402-C-0501: A Phase I Dose-finding and Pharmacokinetic Study of RTA 402 (CDDO-Me) Administered Orally for 21 Days of a 28-day Cycle in Patients With Advanced Solid Tumors or Lymphoid Malignancies

RTA 402 is a new man-made drug that is designed to inhibit (turn off) genes that may activate your cancer cells and cause them to grow. This drug has not been tested in humans.

If you are found to be eligible to take part in this study, you will take RTA 402 by mouth (several capsules a day) in the morning with a glass of water (before eating) on the dose level that will be assigned to you. The dose level you receive will depend on when you begin on this study. You will receive the study drug for 21 days in a row. You will not take the study drug for the next 7 days. This is considered a rest period. These 28 days equal 1 cycle. You should take your study drug as instructed. If a dose is missed or vomited, it will not be replaced either on that day or at the end of the 21-day treatment period.

At the beginning of the study, one to three patients may be enrolled at each dose level, and dose will be doubled between groups until the first occurrence of intolerable side effects during Cycle 1. At the first occurrence of less severe side effects, groups will be expanded to 3-4 patients. Dose escalation (increasing) will continue in this way until researchers learn the highest dose that is best tolerated. You will remain at the same dose level that you started on for at least 2 cycles. After at least 2 cycles, your dose may be increased to another dose that has been determined to be safe. If your disease gets worse or you experience any intolerable side effects, you will be taken off this study.

On Cycle 1 on Days 1 and 21, you will be asked to go to the Clinical and Translational Research Center for your dose of the study drug. You will be asked about how you are feeling, and about any medications you may be taking including any over the counter medication, herbs, and alcohol. You will be asked to report any bad side effects you may experience from the study drug. You will have blood draws (about 1 1/2 teaspoons each time) for PK studies. You will have these PK blood draws before you take RTA 402 at 15 minutes, 30 minutes, and 1, 2, 4, 6, 8, and 24 hours after you take the study drug. You will have your vital signs measured at 2, 4, and 8 hours after taking RTA 402. You will have your urine collected over a 24-hour period. The study staff will provide the urine sample container and explain how to collect your urine.

During Cycle 1, you will return to the clinic every week to have routine blood drawn (about 2 teaspoons) to check the status of your disease. You will be asked how you are feeling and about any medications you may be taking including any over the counter medication, herbs, and alcohol.