Clinical trial: NCT02987959
Section: Alternatives
Subsections: What Other Choices Do You Have If You Do Not Take Part In This Research Study?

Your other choices may include: Getting treatment or care for your cancer without being in a study Taking part in another study Getting no treatment Getting comfort care, also called palliative care. This type of care helps reduce pain, tiredness, appetite problems and other problems caused by the cancer. It does not treat the cancer directly, but instead tries to improve how you feel. Comfort care tries to keep you as active and comfortable as possible. Talk to your doctor about your choices before you decide if you will take part in this study.
Clinical trial: NCT02987959
Section: Confidentiality
Subsections: Will Your Medical Information Be Kept Private? Irb: Page 8 Of 10

We will do our best to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used.  
Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include: Fox Chase Cancer Center and affiliated Joint Centers, The Institutional Review Boards of The Fox Chase Cancer Center and Temple University, Temple University, Temple University Health system, Inc., and its affiliates or subsidiaries and other authorized representatives of these organizations.  
Millennium Pharmaceuticals, Inc. The National Cancer Institute (NCI) and other government agencies, like the Food and Drug Administration (FDA), involved in keeping research safe for people
A description of this clinical trial will be available on *http://www.ClinicalTrials.gov*, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time. You will be given a separate form to review regarding the steps we will take to guard your privacy as part of your participation in the research study. By signing that additional authorization, you will be providing your consent to use and disclose information described in that form connected with your participation in this research study.
Clinical trial: NCT02987959
Section: Duration of Study Involvement
Subsections: After You Stop Taking The Study Drug End Of Treatment Follow-Up|Follow-Up|How Long Will You Be In The Research Study?

About 30 days after your last dose of study drug, you will need following exams.  
We will ask you about the medicine you are taking We will do a physical exam which will include weight and vital signs We will ask about your ability to do your daily activities Routine Blood tests (1 tablespoon).  
Routine urine test We will check your heart by performing an EKG. We will ask you about any side effects you may be experiencing We will evaluate your cancer by doing a CT scan or MRI

After you are finished taking the study drug, we would like to follow up with you for the rest of your life to monitor your overall health. We would like to do this by calling you on the telephone every 3 months.

You will be asked to take the study drugs until your disease gets worse or you experience intolerable side effects. After you stop taking TAK-228, the study doctor will follow up with you for the rest of your life to monitor your overall health.
Clinical trial: NCT02987959
Section: Participant's Rights
Subsections: What Are Your Rights If You Take Part In This Research Study?

Taking part in this research study is your choice. You may choose either to take part or not to take part in the research study. If you decide to take part in this study, you may leave the study at any time. No matter what decision you make, there will be no penalty to you and you will not lose any of your regular benefits. Leaving the study will not affect your medical care. You can still get your medical care from our institution. In the case of injury resulting from this study, you do not lose any of your legal rights to seek payment by signing this form.
Clinical trial: NCT02987959
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Side Effects Or Risks Can You Expect From Being In The Research Study?|Other Potential Risks|Radiation Risk For Diagnostic Imaging|Reproductive Risks|Precautions And Restrictions|Are There Benefits To Taking Part In The Study?|What If I Get Hurt Or Sick While I Am In The Study?

You may have side effects while on the research study. Everyone taking part in the research study will be watched carefully for any side effects. However, doctors don't know all the side effects that may happen. Side effects may be mild or very serious. Your health care team may give you medicines to help lessen side effects. Many side effects go away soon after you stop taking Tak-228. In some cases, side effects can be serious, long lasting, or may never go away. There is also a risk of death. Some deaths have occurred in current human studies: one patient receiving TAK-228 died unexpectedly due to ventricular fibrillation (an abnormal heart rhythm) and cardiac arrest (the heart stops working), events that were assessed as related to TAK-228. With the limited experience we have with TAK-228, we have not determined whether TAK-228 is directly associated with these problems. Other patients receiving TAK-228 have died due to problems related to their cancer, which were not related to taking TAK-228. You should talk to your study doctor about any side effects that you have while taking part in the research study. Risks and side effects related to Tak-228 include those which are:  
Most Common (more than **30%)**
High blood sugar (symptoms may include increased hunger, increased thirst, dry mouth and increased urination)
Nausea (feeling sick to your stomach) Vomiting (throwing up) Decreased appetite Diarrhea (increased frequency of bowel movements with loose, watery stools)
Fatigue Irritation to the lining of your mouth, or mouth sores Very Common (between 10% and **30%)**
Skin irritation, including rash and itching Increased weakness Change of taste Headache Anemia (decrease in the number of red blood cells) which may make you feel tired or weak Dry mouth Pain in the stomach Urinary tract infection (symptoms may include pressure, frequency urinating, urgency to urinate, or a burning sensation while urinating)
Constipation (difficulty having a bowel movement)
Fever Back pain Trouble Breathing Dehydration or excessive water loss Increased creatinine (this may or may not be a sign of damage to your kidney) Changes in the electrolytes (such as potassium, magnesium or phosphates) in the blood Weight loss Cough Dizziness (a feeling of light-headedness)

Decreased platelet counts. Platelets are important in stopping bleeding. A low platelet count can increase the time to form a blood clot.  
Increase in liver function tests (this may or may not be a sign of damage to your liver; you may not notice any symptoms) Inflammation (irritation) of the lungs which may cause shortness of breath and low oxygen levels. Your doctor will monitor you for this.

It is unlikely that there will be any harmful effects from the radiation exposure you will receive from participating in this study.  
At high levels of exposure, scientists agree that radiation can cause cancer. At low exposure levels most scientists agree that the risk, if any, is very low. You will have low levels of radiation exposure with diagnostic imaging procedures.  
Risks from exposure to radiation may accumulate over a lifetime.  
Blood Draw **Risks**
Fainting Bleeding Bruising at the place on your arm where the blood was drawn or needle inserted Pain Swelling Infection (rare)

Study treatments may make you sterile (unable to have children).  
The drugs in this study may affect a baby, before or after the baby is born.  
You should not become pregnant or father a baby while on this research study because the drugs you take could possibly hurt an unborn baby.  
If you are pregnant now or if you are breast-feeding now, you may not take part in this research study.  
If you become pregnant while you are on the research study, you may not continue to take part in the research study.  
For women who can become pregnant:
You should not become pregnant while you are in this study. You should not breast-feed your baby while taking drugs for this research study.  
If you are having sex that could lead to pregnancy, you should use birth control during the study and for at least 3 months after the end of study treatment.  
For men:
You should not make a woman pregnant while you are in this study. If you are having sex that could lead to pregnancy, you should use birth control during the study and for at least 4 months after the end of study treatment.  
For women and men:
Check with the study doctor about birth control methods. Some methods might not be approved for use in this study.

The use of live vaccine and close contact with those who received live vaccines should be avoided during treatment with study drug. Examples of live vaccines are: intranasal influenza, measles, mumps, rubella, oral polio, Bacillus Calmette-Guerin, yellow fever, varicella and TY21a typhoid vaccines.

Taking part in this study may or may not make your health better. While doctors hope that Tak228 will be more useful against cancer compared to the usual treatment, there is no proof of this yet. We do know that the information from this study will help doctors learn more about Tak-228 as a treatment for cancer. This information could help future cancer patients.

If you are injured as a result of your participation in this research study, seek immediate medical care. Temple University Health System or its subsidiaries will treat the injury, though there is no commitment to provide monetary compensation or free medical care. Other financial compensation (such as lost wages or pain and suffering) for such injuries is not available. In the case of injury resulting from this study, you do not lose any of your legal rights to seek payment by signing this form.
Clinical trial: NCT02987959
Section: Procedures
Subsections: What Will Happen If You Take Part In This Research Study? Screening Before You Begin The Research Study|During The Research Study|Study Plan

You will need to have the following exams, tests or procedures to find out if you can be in the research study. These exams, tests or procedures are part of regular cancer care and may be done even if you do not join the research study. If you have had some of them recently, they may not need to be repeated. This will be up to your study doctor.  
We will ask you about your medical history and medicine you are taking We will do a physical exam which will include height, weight and vital signs We will ask about your ability to do your daily activities Routine blood tests (1 tablespoon) Routine urine test Blood pregnancy test (2 teaspoon), if you are a female and able to become pregnant. We will evaluate your cancer by doing a CT scan or MRI
o A CT scan is a computerized x-ray that gives your study doctor pictures of the inside of your body.  
o MRI is a test that uses magnetic field and radio waves to take pictures of the inside of your body.  
We will check your heart by performing an EKG.  
o EKG is a test to measure the electrical activity of your heart Perform a biopsy to obtain a tumor tissue sample (this will not be required if you have a sample from a previous biopsy).

If the exams, tests and procedures show that you can be in the research study, and you choose to take part, then you will take study treatment and you will need some tests and procedures.  
You will receive the study drug every day of a 21 day cycle until your disease gets worse.
Note: you will need to take the study drug once daily at approximately the same time each day. You should refrain from eating and drinking (except for water and other prescribed medications that your doctor may have indicated) for 2 hours before and 1 hour after each dose. You should avoid contact with the powder in TAK-228 capsules. Do not crush or chew the TAK-228 capsules. Should TAK-228 powder release from a capsule, avoid contact with your skin, ears, nose, and mouth. The area should be thoroughly washed with water if such contact occurs.  
People taking the study drug are asked to drink plenty of liquids to maintain normal hydration. You should tell your doctor if you are having trouble eating or drinking normally or if you have diarrhea or stomach upset.  
We will ask you about the medicine you are taking We will do a physical exam which will include weight and vital signs We will ask about your ability to do your daily activities Routine Blood tests (1 tablespoon).  
Routine urine test Blood pregnancy test (1 teaspoon), if you are a female and able to become pregnant.  
Home blood glucose monitoring: You will receive a glucometer for monitoring your blood glucose level at home. The study staff will instruct you how to do home glucose monitoring. You will need to measure your pre-dose fasting blood glucose level and record the values in your dairy. If your blood glucose level is more than or equal to 150mg/dL, you need to notify the study staff immediately. There is minimal risk associated with the blood glucose test. There is a chance of infection if you share the finger-stick device with someone else.  
We will check your heart by performing an EKG. We will ask you about any side effects you may be experiencing We will evaluate your cancer by doing a CT scan or MRI

Another way to find out what will happen to you during the research study is to read the chart below. Start reading at the top and read down the list, following the lines and arrows.
Clinical trial: NCT02987959
Section: Purpose of Research
Subsections: Why Is This Research Study Being Done?

The purpose of this research study is to test if TAK-228 is safe and effective in treating patients with soft tissue sarcoma. The study drug, TAK-228 has not been FDA approved but it has been shown to prevent tumor growth in animals and is currently being tested in humans. We do not know if you will benefit from this research study. It is possible that your condition will get better, but it is also possible that there will be no effect on your condition or that your condition will get worse. We can use what we learn from this research study to help other people with the same disease.
Clinical trial: NCT02987959
Section: Withdrawal from Study
Subsections: Can You Stop Being In The Research Study?|Can You Be Removed From This Research Study?

Your participation in this research is completely voluntary. If you agree to participate now and change your mind later, you may withdraw at any time. Tell the study doctor if you are thinking about stopping or decide to stop. He or she will tell you how to stop safely and will discuss with you options for withdrawl such as continuing to provide further data collection from routine medical care. It is important to tell the study doctor if you are thinking about stopping so any risks from the TAK-228 can be evaluated by your doctor. Another reason to tell your doctor that you are thinking about stopping is to discuss what followup care and testing could be most helpful for you.

The study doctor may stop you from taking part in this research study at any time if he/she believes it is in your best interest; if you do not follow the research study rules; or if the research study is stopped.