Phase II Study of TAK228 in Relapsed Lymphoma

Lymphoma Clinical Trial

Official title: Phase II Study of TAK228 in Relapsed Lymphoma

Status Terminated

Clinical Trial Summary

The goal of this clinical research study is to learn if TAK-228 can help to control relapsed lymphoma. The safety of this drug will also be studied.

Clinical Trial Description

Study Drug Administration:

If you are found to be eligible for this study, you will begin taking capsules of TAK-228 in 28-day cycles. You will take the drug 1 time every day at about the same time. You should take the drug with about a cup (8 ounces) of water after eating a light meal. You should fast for 2 hours before and 1 hour after each dose.

If you vomit or have other digestive side effects that prevent you from taking a dose, that dose should be skipped. If you vomit up a dose, that dose should not be retaken. In both cases, wait until the next day to take another dose. In no case should you double or repeat a dose. You should record any vomiting in the dose diary the study staff provides you with.

Study Visits:

Within 3 days before you start taking TAK-228, blood (about 2 teaspoons) will be drawn for biomarker testing. Biomarkers are found in the blood/tissue and may be related to your reaction to the study drug.

On Day 1 of each cycle:

• You will have a physical exam.

• Blood (about 2-3 tablespoons) will be drawn for routine tests. You must fast for 4 hours before this blood draw. Some of these draws will be used for a diabetes test. If you can become pregnant, part of this sample will be used for a pregnancy test.

• Blood (about 2 teaspoons) will be drawn for biomarker testing (Cycles 1 and 2 only).

• You will have an EKG (within 3 days of each cycle after Cycle 1).

On Days 8 and 22 of Cycle 1, you will have a physical exam.

On Day 15 of Cycle 1:

• You will have a physical exam

• Blood (about 2-3 tablespoons) will be drawn for routine tests.

Within 5 days before Day 1 of Cycle 3, then every even-numbered cycle after that (Cycles 4, 6, 8, and so on), you will have CT scans, chest x-rays, and a bone marrow biopsy/aspiration to check the status of the disease.

If the study doctor thinks it is in your best interest, you will have PET/CT scans every 2 cycles to check the status of the disease.

Blood Sugar Testing:

You will be given a glucometer to check your pre-dose blood sugar levels at home every day. The study staff will teach you how to use the glucometer and what an abnormal reading looks like. You must tell the study staff right away if you have any abnormal readings. The frequency of in-home fasting glucose testing may be reduced to once weekly if the doctor thinks it is needed.

Length of Study:

You may continue to receive the study drug for up to 12 cycles. You will no longer be able to take the drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation in this study will be over after the follow-up phone calls have finished.

End-of-Treatment Visits:

About 1 week after you stop taking the study drug:

• You will have a physical exam

• Blood (about 2-3 tablespoons) will be drawn for routine tests and to test for diabetes. This will include a pregnancy test if you are able to become pregnant.

• You will have an EKG.

About 2 weeks after you stop taking the study drug, you will have CT scans and chest x-rays to check the status of the disease. If the study doctor thinks it is needed, you will also have a bone marrow biopsy/aspiration to check the status of the disease.

Within 2 weeks after you stop taking the study drug, blood (about 2 teaspoons) will be drawn for biomarker testing.

This is an investigational study. TAK-228 is not FDA approved or commercially available. It is currently being used for research purposes only. The study doctor can describe how the study drug is designed to work.

Up to 75 participants will be enrolled in this study. All will take part at MD Anderson. ;

Related Conditions & MeSH terms

• Lymphoma

• NCT number: NCT02727777
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: March 1, 2017
• Completion date: July 10, 2018