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Title:
9767 An Open Label, Multicenter, Single arm Phase II study to evaluate the Activity and Tolerability of the novel mTOR Inhibitor, MLN0128 (TAK-228), in patients with Locally Advanced or Metastatic Transitional Cell Carcinoma of the urothelial tract whose tumors harbor a TSC1 and/or a TSC2 mutation
Protocol Number:
ETCTN9767
Phase:
Phase II
Physician:
Noah Hahn
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
The purpose of this study is to test any good and bad effects of the study drug called MLN0128 (TAK-228). This study is being done to see if MLN0128 (TAK-228) is effective in treating your type of cancer.
Eligibility:
Generally healthy adults who have a urinary tract cancer with a mutation in TSC1 and/or TSC2 genes that has already been treated with chemotherapy and is now growing may be eligible.
Treatment:
All study participants will get the same study intervention. It will include the study drug MLN0128 (TAK-228), taken by mouth once every day for 28 days per cycle. All study participants will get the study drug MLN0128 (TAK-228). Before starting treatment with TAK-228, you will be provided an in-home glucometer and supplies. You will be trained on proper use of the glucometer and instructed to collect a daily finger stick blood sugar level before eating each morning. You should bring your glucometer with you to each study visit so that the data collected can be reviewed and recorded.You will also receive a pill diary to record when you take the study drug at home and to record blood sugar level. This pill diary will also provide specific instructions on how to take the study drug. You will also receive a drug information handout and wallet card as a resource for yourself, caregivers and other healthcare providers. You will be advised to avoid eating or drinking grapefruit and grapefruit juice during the study. You will continue to receive the study drug as long as your study doctor thinks that the drug is helping you. This is determined by the scans results and the side effects that you may have. Your study doctor may stop the treatment when your disease gets worse, when you develop unacceptable side effects, or when you have other medical problems that prevents you from receiving the study drug. The treatment may also be stopped when you withdraw your consent. If you stopped taking the study medication because your disease got worse, your study doctor will continue to watch you for side effects and follow your condition for 4 weeks. If you stop taking the drugs because of the other reasons, your study doctor and/or the research team may follow up with you for a longer period of time. After you finish this treatment, your doctor or the study team will be in contact with you via a phone call or review your medical record every 6 months to follow your survival status.
Population:
Adult
Last Update
03/05/2019 05:03 AM