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10075 A Phase 1B Study of AMG-232 in Combination with Decitabine in Acute Myeloid Leukemia (ETCTN)
Protocol Number:
Phase I
Jonathan Webster
Johns Hopkins Kimmel Cancer Center in Baltimore
The purpose of this study is to test the safety of an investigational study drug called AMG-232 in combination with treatment called decitabine.
Patients with acute myeloid leukemia (AML) who are newly diagnosed or have been treated with chemotherapy but your disease is growing may be eligible.
This study will be done in two parts. The first part is called the Dose Escalation Phase and the second part is the Expansion Phase. The dose of the study drugs you receive will depend on when you enroll in the study. The study doctor will tell you to which of the following parts of the study you have been assigned. You may receive the study drugs in the hospital or on an outpatient basis depending on your overall condition.AMG-232 is a tablet that you will take by mouth every day on an empty stomach in the morning, at least 2 hours before or 1 hour after a meal. Dose Escalation Part:Different doses of the study drug AMG-232 will be given to several study participants along with decitabine. The first several study participants will receive the lowest dose. If the drug does not cause serious side effects, it will be given to other study participants at a higher dose. The doses will continue to increase for every group of study participants until side effects occur that require the dose to be lowered. Expansion Part:The dose of AMG-232 along with decitabine identified in Dose Escalation Part will be tested further in the next 10 participants. The dose of the study drug might be decreased or kept the same depending on the side effects.You will receive AMG-232 and decitabine for up to 4 cycles (or approximately 4 months) of treatment until a complete response is reached. After you stop taking AMG-232, your doctor will continue to watch you for 30 days. If you are removed from due to side effects you will be followed until resolution or stabilization of your side effects.
Last Update
08/08/2020 05:02 AM