Phase I Study of the Safety and Tolerability of ATR-101 in Adrenocortical Carcinoma
This study is researching all of the following topics:Adrenal cancer
Location of study visits:
Ann Arbor, MI
This study is looking for:
Both men and women
Volunteers with specific conditions
This study will evaluate the safety of an investigational drug called ATR-101 and determine the highest safe dose that can be administered in adult participants with adrenocortical cancer that have failed standard chemotherapy.
What is involved?A participant in a Phase I clinical study has completed approved therapies for their cancer, and may be a candidate for participation in an experimental study. A potential participant for this study will need to be evaluated by a University of Michigan medical oncologist, and assessed for eligibility for this study. This study has strict criteria for participation with limited enrollment.If you are eligible you will return to UM for study treatment.Study treatment is administered in 4 week cycles.ATR-101 is taken by mouth once a day in the morning every day on an empty stomach.You should not eat for 2 hours before and for at least 1 hour after your ATR-101 dose;you may drink moderate amounts of water or other clear liquids.The number of ATR-101 capsules you take will depend on the dose level determined by the sponsor and will not change during your study participation.You will take your ATR-101 dose whole with water and will not break or chew the capsules.You will be given a pill diary to record the date and time you take your dose of ATR-101 and will bring it with you to every UM visit.You will be required to return to UM to undergo tests and evaluations during treatment.During Cycle 1 you will visit UM 7-8 times;2 visits will last 8-9 hours, 2 visits will last about 1-2 hours, and 3 visits will last about 3-4 hours.During Cycles 2 and 3 you will visit UM 3 times;1 will last about 1 hour, 1 will last about 2-3 hours, and one will last about 3-4 hours.During all subsequent cycles you will visit UM 2 times;one visit for about 1 hour, and 1 visit for about 3-4 hours.You will return to UM for a Final Visit Evaluation that will last about 2-3 hours.Your participation in this study will continue as long as your cancer is stable or improving, you do not have medically unacceptable effects from ATR-101, you follow study instructions, you volunteer to continue, your study doctor determines continuation appropriate, and you do not become pregnant.
CompensationThere may be some travel expenses covered during your study treatment.Your study doctor can give you the exact details of the expenses covered.You will not be paid to participate in this research study.
It is very important for you to keep every appointment, and should only consider participation if you are willing to do so.This is the first study to administer ATR-101 in humans and therefore the risks and side effects of ATR-101 in humans are not known.Side effects may be mild or very serious, and in some cases maybe very serious, long-lasting, or may never go away.Your study doctor may order other medications to make side effects less severe or to make you feel more comfortable.There is also risk of death.You may not receive any personal benefits from being in this study.Your participation in this study may help the investigators better understand ATR-101;this information may benefit others with adrenocortical cancer in the future.IRB number: HUM00074054 Study posted on: 08/27/2014 Posting will be taken down on: 08/31/2016
Study TeamPrincipal Investigator: Smith, David CDepartment: Internal Medicine - Hematology & Oncology