Clinical trial: NCT03040986
Section: Alternatives
Subsections: What Are My Other Choices If I Do Not Take Part In This Study?

If you decide not to take part in this study, you have other choices. For example:  
- you may choose to have the usual approach described above
- you may choose to take part in a different study, if one is available - or you may choose not to be treated for cancer but you may want to receive comfort care to relieve symptoms.
Clinical trial: NCT03040986
Section: Confidentiality
Subsections: Who Will See My Medical Information?|How Will Information About Me Be Kept Private?

Your privacy is very important to us and the researchers will make every effort to protect it. Your information may be given out if required by law. For example, certain states require doctors to report to health boards if they find a disease like tuberculosis. However, the researchers will do their best to make sure that any information that is released will not identify you. Some of your health information, and/or information about your specimen, from this study will be kept in a central database for research. Your name or contact information will not be put in the database. There are organizations that may inspect your records. These organizations are required to make sure your information is kept private, unless required by law to provide information. Some of these organizations are:
- The study sponsor, CTEP and any drug company supporting the study.  
- The Institutional Review Board, IRB, is a group of people who review the research with the goal of protecting the people who take part in the study.  
- The Food and Drug Administration and the National Cancer Institute in the U.S., and similar ones if other countries are involved in the study.

Your privacy is very important to the researchers and they will make every effort to protect it. Here are just a few of the steps they will take:  
1) When your samples are sent to the researchers, no information identifying you (such as your name) will be sent. Samples will be identified by a unique code only.  
2) The list that links the unique code to your name will be kept separate from your sample and health information.  
3) Researchers to whom the Biobank sends your sample and information will not know who you are.  
4) Information that identifies you will not be given to anyone, unless required by law. 5) If research results are published, your name and other personal information will not be used.
Clinical trial: NCT03040986
Section: Duration of Study Involvement
Subsections: How Long Will I Be In This Study?

The screening phase of this study can take up to 2 weeks for archival tumor samples, and up to 3 weeks if a biopsy is needed test for the KRAS G12R genetic change or no time at all if you already have test result of KRAS mutation ststus. For participants having a tumor with the KRAS G12R genetic change, you will receive the selumetinib for as long as you are able to tolerate the study drug and it keeps your cancer from further growing for up to 27 cycles which is about two years. After you finish the study drug, your study team will call you every two months for up to one year to follow your condition. If you have any side effects from the study drug after you finish the study, your doctor will follow you until your symptoms get better.
Clinical trial: NCT03040986
Section: Participant's Rights
Subsections: What Are My Rights In This Study?

Taking part in this study is your choice. No matter what decision you make, and even if your decision changes, there will be no penalty to you. You will not lose medical care or any legal rights. For questions about your rights while in this study, contact the National Cancer Central Institute Institutional Review Board (NCI CIRB) at 888-657-3711
Clinical trial: NCT03040986
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: A Study Calendar That Shows How Often These Tests And Procedures Will Be Done Is Attached. What Possible Risks Can I Expect From Taking Part In This Study?|Possible Side Effects Of Selumetinib (Azd6244)|Research Procedure Risks: Blood Draw|Reproductive Risks:|Other Risks:|What Possible Benefits Can I Expect From Taking Part In This Study?|What Are The Costs Of Taking Part In This Study?|What Happens If I Am Injured Or Hurt Because I Took Part In This Study?|What Are The Possible Risks?|What Are The Possible Benefits?|Are There Any Costs Or Payments?

If you choose to take part in this study, there is a risk that:
- You may lose time at work or home and spend more time in the hospital or doctor's office than usual  
- You may be asked sensitive or private questions which you normally do not discuss
- There is a risk someone could get access to the personal information in your medical records or other information researchers have kept about you. Someone might be able to trace this information back to you. The researchers believe the chance that someone will identify you is very small, but the risk may change in the future as people come up with new ways of tracing information. In some cases, this information could be used to make it harder for you to get or keep a job. There are laws against misuse of genetic information,
but they may not give full protection. The researchers believe the chance these things will happen is very small, but cannot promise that they will not occur.  
- There can also be a risk in finding out new genetic information about you. New health information about inherited traits that might affect you or your blood relatives could be found during a study.
The selumetinib used in this study may affect how different parts of your body work such as your liver, kidneys, heart, and blood. The study doctor will be testing your blood and will let you know if changes occur that may affect your health. There is also a risk that you could have side effects from the study drug(s)/study approach. Here are important points about side effects:  
- The study doctors do not know who will or will not have side effects.  
- Some side effects may go away soon, some may last a long time, or some may never go away.  
- Some side effects may interfere with your ability to have children. - Some side effects may be serious and may even result in death.
Here are important points about how you and the study doctor can make side effects less of a problem:  
- Tell the study doctor if you notice or feel anything different so they can see if you are having a side effect.  
- The study doctor may be able to treat some side effects. - The study doctor may adjust the study drugs to try to reduce side effects.  
- The study doctor will provide you with information about other drugs you may need to avoid while receiving the study drug.
The tables below show the most common and the most serious side effects that researchers know about. There might be other side effects that researchers do not yet know about. If important new side effects are found, the study doctor will discuss these with you.

COMMON, SOME MAY BE SERIOUS
In 100 people receiving selumetinib (AZD6244), more than 20 and up to 100 may have:
- Diarrhea, nausea - Swelling of the body - Tiredness  
| - Acne, rash   |
|----------------|  
OCCASIONAL, SOME MAY BE SERIOUS
In 100 people receiving selumetinib (AZD6244), from 4 to 20 may have:
- Anemia which may require blood transfusion - Pain
- Constipation, vomiting - Dry mouth, skin
- Sores in mouth which may cause difficulty swallowing - Fever - Bruising, bleeding - Infection, especially when white blood cell count is low - Loss of appetite
- Dizziness, headache
- Cough, shortness of breath
- Hair loss, itching
- High blood pressure which may cause headaches, dizziness, blurred vision RARE, AND SERIOUS
In 100 people receiving selumetinib (AZD6244), 3 or fewer may have:
- Heart failure which may cause shortness of breath, swelling of ankles, and tiredness

Side effects of blood draws include pain and bruising in the area where the needle was placed, lightheadedness, and rarely, fainting. When large amounts of blood are collected, low red blood cell count (anemia) can develop.

You should not get pregnant, breastfeed, or father a baby while in this study. The selumetinib used in this study could be very damaging to an unborn baby. Check with the study doctor about what types of birth control, or pregnancy prevention, to use while in this study. If you are a woman who can become pregnant, or are the partner of a woman who can become pregnant, you will need to practice an effective form of birth control before starting study drug, during taking study drug, and for up to 4 weeks (female patients) or 12 weeks (male patients) after you finish study drug. If you think that you or your partner is pregnant, you should tell your study doctor or nurse at once. Effective forms of birth control include:
- abstinence  
- intrauterine device (IUD)
- hormonal [birth control pills, injections, or implants]
- tubal ligation
- vasectomy

- In case of diarrhea you can have additional tests to address the need for immediate, aggressive treatment of diarrhea such as measurement of blood pressure and heart rate, urine and blood tests to check your organ functions.  
- Please, avoid excessive sun exposure and use adequate sun protection measures.

This study has only a small chance of helping you because we do not know if the study drug/study approach is effective. This study may help researchers learn things that may help other people in the future.

The study drug will be supplied at no charge while you take part in this study. The cost of getting the study drug ready and giving it to you, however, is not paid by the study sponsor so you or your insurance company may have to pay for this. It is possible that the study drug may not continue to be supplied while you are on the study. Although not likely, if this occurs, your study doctor will talk to you about your options. You and/or your health plan/insurance company will need to pay for all of the other costs of treating your cancer while in this study, including the cost of tests, procedures, or medicines to manage any side effects, unless you are told that certain tests are supplied at no charge. Before you decide to be in the study, you should check with your health plan or insurance company to find out exactly what they will pay for.  
You will not be paid for taking part in this study.

If you are injured or hurt as a result of taking part in this study and need medical treatment, please tell your study doctor. The study sponsors will not offer to pay for medical treatment for injury. Your insurance company may not be willing to pay for study-related injury. If you have no insurance, you would be responsible for any costs. If you feel this injury was a result of medical error, you keep all your legal rights to receive payment for this even though you are in a study.

1) There is a risk that someone could get access to the personal information in your medical records or other information researchers have stored about you.  
2) There is a risk that someone could trace the information in a central database back to you. Even without your name or other identifiers, your genetic information is unique to you. The researchers believe the chance that someone will identify you is very small, but the risk may change in the future as people come up with new ways of tracing information.  
3) In some cases, this information could be used to make it harder for you to get or keep a job or insurance. There are laws against the misuse of genetic information, but they may not give full protection. There can also be a risk in knowing genetic information. New health information about inherited traits that might affect you or your blood relatives could be found during a study. The researchers believe the chance these things will happen is very small, but cannot promise that they will not occur.  
4) There is a risk that the sample used for unspecified future research could be needed to determine if you are eligible for other treatments or clinical trials.

You will not benefit from taking part. Your samples may be helpful to research. The researchers, using the samples from you and others, might make discoveries that could help people in the future.

There are no costs to you or your insurance. You will not be paid for taking part. If any of the research leads to new tests, drugs, or other commercial products, you will not share in any profits.
Clinical trial: NCT03040986
Section: Procedures
Subsections: What Are The Study Groups?|What Extra Tests And Procedures Will I Have If I Take Part In This Study?|What Is Involved?

This study has two phases. Everyone who agrees to take part in the study will be in Group 1. Only patients with a tumor sample testing positive for the KRAS G12R genetic change will continue to the Group 2 phase of the study. Group 1 (Screening Phase). All participants must provide a test result from CLIA certified laboratory, confirming somatic KRAS G12R mutation or tumor sample to test for the KRAS G12R genetic change. The tumor sample can be from:
- Archival tumor sample that was previously acquired at diagnosis (no biopsy required)  
- Or a biopsy (if the archival sample is not available).
*The tumor sample is then tested for the KRAS G12R genetic change. It is expected that for every 100 patients with pancreas cancer, about 15 samples of the tumor will be positive for the KRAS G12R genetic change. The risks of this genetic test are further explained below in "What extra tests and procedures will I have if I take part in this study?" If the test is negative for the KRAS G12R genetic change you are then taken off study. Group 2 (Testing Phase) All participants having a tumor with the KRAS G12R genetic change will get selumetinib as a capsule at a dose of 75 mg to be taken twice a day. The study doctor might lower the dose if you have serious side effects. The study drug is given over 4-week periods of time called cycles. The 4-week cycle will be repeated as long as you are tolerating the study drug and your cancer is either stable or getting better. No other therapy for pancreas cancer will be given while you are on study. You will be given a Patient's Pill Diary that explains how to take the study drug and to record when you take the capsules at home. You will also be given a study drug handout and wallet card as a resource for yourself, caregivers and other health care providers.

Most of the exams, tests, and procedures you will have are part of the usual approach for your cancer. However, there are some extra tests that you will need to have if you take part in this study.

If you agree to take part in biobanking, here is what will happen next:  
1) Your left over samples and some related health information may be stored in the Biobank, along with samples and information from other people who take part. The samples will be kept until they are used up. Information from your medical record will be updated from time to time.  
2) Qualified researchers can submit a request to use the materials stored in the Biobank.  
There will also be an ethics review to ensure that the request is necessary and proper. Researchers will not be given your name or any other information that could directly identify you.  
3) You will not be notified when future studies will be conducted or given reports or other information about any research that is done using your samples.  
4) Some of your genetic and health information may also be placed in central databases that may be public, along with information from many other people. Information that could directly identify you will not be included.
Clinical trial: NCT03040986
Section: Purpose of Research
Subsections: Why Is This Study Being Done?

The purpose of this study is to test any good and bad effects of the study drug called selumetinib (AZD6244). Selumetinib could shrink your cancer but it could also cause side effects.. Researchers hope to learn if the study drug will shrink the cancer by at least 30 %. Selumetinib has not been approved by the U.S. Food and Drug Administration (FDA) in the treatment of any cancer. It has not been tested in pancreatic cancer, but has shrunk tumors in patients with lung tumor, thyroid cancers, or in patients with a certain eye tumors. Up to 60 people will take part in the screening study described in Group 1 below. Of those people, up to 25 people will have the KRAS G12R genetic change that is needed to take part in the testing of the study drug selumetinib (Group 2 below).
Clinical trial: NCT03040986
Section: Voluntary Participation
Subsections: My Signature Agreeing To Take Part In The Main Study

I have read this consent form or had it read to me. I have discussed it with the study doctor and my questions have been answered. I will be given a signed copy of this form. I agree to take part in the main study and any additional studies where I circled 'yes'.  
Participant's signature________________________________ Date of signature_____________________________________ Signature of person(s) conducting the informed consent discussion___________________________________ Date of signature_____________________________________
Clinical trial: NCT03040986
Section: Withdrawal from Study
Subsections: Can I Stop Taking Part In This Study?|What If I Change My Mind?

Yes. You can decide to stop at any time. If you decide to stop for any reason, it is important to let the study doctor know as soon as possible so you can stop safely. If you stop, you can decide whether or not to let the study doctor continue to provide your medical information to the organization running the study. The study doctor will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study. The study doctor may take you off study drug:
- If your health changes and the study is no longer in your best interest  
- If you become pregnant
- If new information becomes available
- If you do not follow the study rules - If the study is stopped by the sponsor, IRB or FDA.  
- If the drug is no longer available.

If you decide you no longer want your samples to be used, you can call the study doctor, Udo Rudloff, MD at 240-760-6238 who will let the researchers know. Then, any sample that remains in the bank will no longer be used and related health information will no longer be collected. Samples or related information that have already been given to or used by researchers will not be returned.