Clinical trial: NCT02203513
Section: Alternatives
Subsections: Alternative Approaches Or Treatments What Other Choices Do I Have If I Do Not Take Part In This Study?

Instead of being in this study, you have these options:
Getting treatment or care for your cancer without being in a study Taking part in another study 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. Instead, it tries to improve how you feel. Comfort care tries to keep you as active and comfortable as possible.  
Please talk to your doctor about these and other options.
Clinical trial: NCT02203513
Section: Confidentiality
Subsections: Who Else Besides The Investigators On This Study Will Know The Results Of My Sample Testing?|How Long Will Your Samples Be Stored?|Will Your Medical Information Be Kept Private?|Certificate Of Confidentiality

Once we obtain any of the samples listed above, the investigators take all your personal information off those samples and label them with a study code number. Only the investigators on this study know who the sample came from. The key linking your personal information with the code number is kept in a secure computer data base, with access only to the 2-3 research staff who will be discussing this study with you. Once the sample has been labeled with a code, it is  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099 File in Section 4: Protocol Consent  
STUDY NUMBER: 14-C-0156 CONTINUATION: page 9 of 17 pages sent to a variety of NIH laboratories for storage and testing. No one testing your samples will be able to link the results to you personally. Specimens obtained during your participation in this study may be sent for testing to investigators outside of NCI or the NIH. All samples will be coded to protect your privacy and no personal information will be included. Other investigators on this study will have access to limited clinical and biologic data such as age, gender and disease status.

The samples collected during this study will be stored for as long as the study is open. When this study is closed, we would like to keep the samples for future research. We will request your permission to do so, later in this consent.

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. Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include:  
The National Cancer Institute (NCI) and other government agencies, like the Food and Drug Administration (FDA), which are involved in keeping research safe for people.  
NIH Intramural Institutional Review Board Qualified representatives from Eli Lilly, the pharmaceutical company who produces LY2306368
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.  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099 File in Section 4: Protocol Consent  
STUDY NUMBER: 14-C-0156 CONTINUATION: page 14 of 17 pages

To help us protect your privacy, we have obtained a Certificate of Confidentiality. The researchers can use this Certificate to legally refuse to disclose information that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, for example, if there is a court subpoena. The researchers will use the Certificate to resist any demands for information that would identify you, except as explained below. You should also know that there are several circumstances in which the Certificate does not provide coverage. These include when information:  
will be used for auditing or program evaluation internally by the NIH; or must be disclosed to meet the legal requirements of the federal Food and Drug Administration (FDA).  
is necessary for your medical treatment and you have consented to this disclosure; is for other research.
In addition, identifiable, sensitive information protected by this Certificate cannot be admissible as evidence or used for any purpose in any action, suit, or proceeding without your consent. You should understand that a Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer, or other person obtains your written consent to receive research information, then the researchers will not use the Certificate to withhold that information. The Certificate of Confidentiality will not protect against the required reporting by hospital staff of information on suspected child abuse, reportable communicable diseases, and/or possible threat of harm to self or others.
Clinical trial: NCT02203513
Section: Duration of Study Involvement
Subsections: Before You Begin The Study|During The Study|Day 1|Day 15|Day 28|Cycle 2 And Beyond|When You Are Finished Taking The Drugs (Treatment)

Certain standards (criteria) have been established to ensure that you are a medically appropriate candidate for this trial. These criteria also make sure that the results of this study can be used to help make decisions about treating other patients. We will record your medical history and give you a physical examination. We will review slides of a previous biopsy you have had to confirm your diagnosis. You will undergo standard blood tests including a complete blood count, chemistry  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099 File in Section 4: Protocol Consent  
STUDY NUMBER: 14-C-0156 CONTINUATION: page 3 of 17 pages panel, a pregnancy test, an EKG, and scans and x-rays as part of the NCI Screening Protocol. One test of your immune system will be a blood test that checks for the presence of the human immunodeficiency virus (HIV), the cause of acquired immunodeficiency syndrome (AIDS). HIV infection may disqualify you from this study. If you test positive for HIV, we will tell you what the results mean, how to find care, how to avoid infecting others, and how we report newly diagnosed HIV infection. If you are eligible to participate in this trial and wish to do so, a CT-assisted biopsy of your tumor will be performed for research purposes before you start treatment. If you are in the one of groups 1-3, an additional CT-assisted biopsy may be performed during Cycle 1 if you agree, after your dose of study drug on Day 15 and at the end of your study treatment. If you are in group 5 and respond to the treatment longer than 4 months, an additional CT-assisted biopsy will be performed when your tumor stops shrinking so that researchers can study what made the tumors stop responding to LY2606368. If you are in group 6, you will not have an additional CT-assited biopsy.

During the study, the study doctor and staff will monitor you for any side effects and monitor your cancer. You may receive supportive care during this study. Ask the study doctor or staff if you have questions about supportive care. During Cycle 1, you will receive weekly phone calls to ask about whether there have been any changes to your health and about any other medications that you may be taking. For safety, during Cycle 1, you will also have routine laboratory tests done weekly, then every other week for Cycle 2 and beyond. About 3 tablespoons of blood will be drawn for these tests.

After all of your baseline tests are complete, you will start treatment. On Day1, the study staff will perform a complete physical exam. They will ask if there have been any changes to your physical health and about any medications you have taken since your screening visit. They will check your vital signs and may do some routine laboratory tests. Laboratory tests that were completed within the last 3 days before Cycle 1 Day 1, will not be repeated. Blood will also be drawn for research tests to assess certain cancer markers (about 2 tablespoons). A CT scan of the chest, abdomen, and pelvis will not be repeated if you had one done within 14 days prior to the start of Cycle 1 Day 1.

On Day 15, you will be asked about whether there have any been any changes to your physical health and about any medications you have taken. The study staff will perform a complete physical examination and you will have some routine laboratory tests done for safety. About 3 tablespoons of blood will be drawn for these tests. If you are in the one of groups 1-3, you will be asked if you want to have a second biopsy. This second biopsy, which would be assisted by a CT scan, is for research purposes and it is optional. Even if you do not want to do this second biopsy, you can still continue on the study. You will also be required to have an EKG and about 2 tablespoons of blood will be drawn to assess certain cancer markers.

On Day 28, the first treatment cycle will end. You will be asked about whether there have been any changes to your health and about any other medications you have taken. You will have a complete physical exam and have about 3 tablespoons of blood drawn for routine laboratory tests. You will also be required to have an EKG.

Some tests will be performed every cycle, some will be performed every other cycle, some will be performed every three cycles, and some will be completed in the first cycle only. If you are in the group 5 and on the treatment longer than 4 months, you will be asked about a second biopsy when your tumors start growing on imaging. This second biopsy, which would be assisted by a CT scan, is for research purposes and it is mandatory for the researchers to study what makes tumors become resistance to the treatment. This mandatory second biopsy will not be done if you (group 5) don't respond to the therapy longer than 4 months. The Study Chart below gives more information about the timing of all of the tests needed for this study.

If you or your study doctor decides to stop study treatment, if your cancer has spread, or if you cannot tolerate the study treatment then you will be asked to return for an end of treatment visit. During this visit, the following will be performed:  
You will have a complete physical examination to assess any changes since the last study visit.  
Your vital signs will be measured.  
You will be asked if you want to have another CT-assisted biopsy. It will be your choice whether you want to have this biopsy done.  
Your cancer will be evaluated through CT scans or MRI of the chest, pelvis, and abdomen.  
Male participants may also be evaluated with bone scans. Your tumor will be checked to see if it has grown, shrunk or stayed the same.  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099 File in Section 4: Protocol Consent  
| MEDICAL RECORD   | CONTINUATION SHEET for either:  NIH 2514-1, Consent to Participate in A Clinical Research Study NIH 2514-2, Minor Patient's Assent to Participate In A Clinical Research  Study   |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|  
STUDY NUMBER: 14-C-0156 CONTINUATION: page 5 of 17 pages You will have an EKG. Blood samples (about 3 tablespoons) will be taken for safety laboratory blood tests, including blood counts, blood clotting ability, and liver, and kidney functions.  
A blood sample (about 2 tablespoons) will be collected to assess certain cancer markers.  
You will be asked about any changes in your health and any changes to the medications that you are taking.  
| Study Chart                                                                  | Subsequent  Cycles and  Study  Completion                                                                                      |                                                                  |
|------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Study Procedures                                                             | Day                                                                                                                            | Blood Samples  (amount)                                          |
| Each visit and  phone follow-up  every week during  Cycle 1                  | Day 1 of every  cycle; Study  Completion                                                                                       |                                                                  |
| History and Physical  Examination                                            | Before treatment;  and 30 minutes  before and after  each infusion and  Day 28                                                 | Same for all  cycles; Study  Completion                          |
| Vital Signs                                                                  | Day 1 and Day 15  of every cycle;  plus the every                                                                              |                                                                  |
| Routine Blood Tests                                                          | Each Visit                                                                                                                     | 3 tablespoons each  week during  Cycle 1 only;  Study Completion |
| CT-assisted Biopsy for Research                                              | Before treatment;                                                                                                              | One at Study                                                     |
| Cycle 1 Day 15*                                                              | Completion*  Once in Cycle 2  and then once  every 3 months  before and within  1 hour after each  infusion; Study  Completion |                                                                  |
| Before treatment;  Cycle 1 Days 1 and  15 within 1 hour  after each infusion |                                                                                                                                |                                                                  |
| EKG  PATIENT IDENTIFICATION                                                  | CONTINUATION SHEET for either:  NIH-2514-1 (07-09)  NIH-2514-2 (10-84)  P.A.: 09-25-0099  File in Section 4: Protocol Consent  |                                                                  |  
for NIH 2514-2, Minor Patient's Assent to Participate In A Clinical Research Study STUDY NUMBER: 14-C-0156 CONTINUATION: page 6 of 17 pages  
| Blood Tests for Research                                                                                                                     | Before treatment;  Day 15   | 2 tablespoons each Once at study  Completion  Patients with  breast or ovarian  cancer: at the  beginning of  every other cycle,  starting with  Cycle 3 Day 1, ,  prior to infusion;  Study Completion   |
|----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Before treatment or  Cycle 1 Day 1 if the  screening scan was  done more than 14  days prior to Cycle  1 Day 1                               |                             |                                                                                                                                                                                                           |
| CT Scan of the chest, abdomen,  and pelvis (tumor assessment to  see if it is shrinking, growing, or  staying the same size)  Pregnancy Test | Before treatment            | None                                                                                                                                                                                                      |
| Study Drug Infusion                                                                                                                          | Day 1, Day 15               | Same for all  cycles                                                                                                                                                                                      |  
* Groups 1-3: Biopsies in Cycle 1 Day 15 and at the completion of the study are not necessary for study participation. The post treatment biopsy will only be requested to study why your tumor does not respond the treatment. Group 5: If you are on LY2606368 treatment longer than 4 months, the post-treatment biopsy will only be requested, to study why your tumor does not respond the treatment. If your tumor briefly responds to LY2606368 less than 4 months, the post treatment biopsy will not be asked.
Clinical trial: NCT02203513
Section: Participant's Rights
Subsections: Research Subject'S Rights What Are The Costs Of Taking Part In This Study?

If you choose to take part in the study, the following will apply, in keeping with the NIH policy:  
You will receive study treatment at no charge to you. This may include surgery, medicines, laboratory testing, x-rays or scans done at the Clinical Center, National Institutes of Health (NIH), or arranged for you by the research team to be done outside the Clinical Center, NIH if the study related treatment is not available at the NIH.  
There are limited funds available to cover the cost of some tests and procedures performed outside the Clinical Center, NIH. You may have to pay for these costs if they are not covered by your insurance company.  
Medicines that are not part of the study treatment will not be provided or paid for by the Clinical Center, NIH.  
Once you have completed taking part in the study, medical care will no longer be provided by the Clinical Center, NIH.
Clinical trial: NCT02203513
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Birth Control|Psychological Or Social Risks Associated With Loss Of Privacy|Risks Or Discomforts Of Participation What Side Effects Or Risks Can I Expect **From Being In This Study?** Ly2606368|Less Likely|Serotonin Syndrome|Qtc Prolongation|Risk Of Radiation|Potential Benefits Of Participation Are There Benefits To Taking Part In This Study?

If you are a woman who is breast feeding or pregnant, you may not take part in the study because we don't know how this medicine would affect your baby or your unborn child. All participants of reproductive capability must agree to use both a barrier method and a second method of birth control during the study and for four months after you finish study treatment. If you are a man who is sexually active, you and your female partner must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the study and for 4 months after you finish the study treatment, even if oral contraceptives are also used. If you think that you, or your female partner if you're a man, are 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]  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099 File in Section 4: Protocol Consent  
STUDY NUMBER: 14-C-0156 CONTINUATION: page 7 of 17 pages
- tubal ligation  
- vasectomy

The following general points are indirectly related to your participation in the research study:  
1. Unanticipated medical information: During the course of this investigation, it is possible
(although not likely) that we will obtain unanticipated information about your health or genetic background.  
2. Release of genetic information Your privacy is very important to us and we will use many safety measures to protect your privacy. However, in spite of all of the safety measures that we will use, we cannot guarantee that your identity will never become known. Although your genetic information is unique to you, you do share some genetic information with your children, parents, brothers, sisters, and other blood relatives. Consequently, it may be possible that genetic information from them could be used to help identify you. Similarly, it may be possible that genetic information from you could be used to help identify them.  
Patterns of genetic variation also can be used by law enforcement agencies to identify a person or his/her blood relatives. Therefore, your genetic information potentially could be used in ways that could cause you or your family distress, such as by revealing that you (or a blood relative) carry a genetic disease.  
There also may be other privacy risks that we have not foreseen.
Since some genetic variations can help to predict future health problems for you and your relatives, this information might be of interest to health care providers, life insurance companies, and others. However, Federal and State laws provide some protections against discrimination based on genetic information. For example, the Genetic Information Nondiscrimination Act (GINA) makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. However, GINA does not prevent companies that sell life insurance, disability insurance, or long-term care insurance from using genetic information as a reason to deny coverage or set premiums. GINA also does not apply to members of the United States military, individuals covered by the Indian Health Service, or veterans obtaining health care through the Veteran's Administration. Lastly, GINA does not forbid insurance medical underwriting based on your current health status though the Affordable Care Act limits consideration of pre-existing conditions by insurers.

As with all treatments, there are several side effects or risks from the treatment provided in this study. However, doctors don't know all the side effects that may happen with this drug, so it is important to report any changes that you notice, even if your study team does not ask specifically about them. Side effects may be mild or severe. Your study team will give you medicines to help lessen side effects. Many side effects go away with those medicines and others may go away soon after you stop treatment. In some cases, side effects can be serious, long-lasting, or may never go away. In very rare instances, they could cause death. Just over 100 people have been treated with this study drug. Based on what these people reported the possible side effects are described below: Likely  
Low white blood cell count (which can increase your risk for infections)
Low red blood cell count Low platelet count (increases your risk of bleeding) Nausea Fatigue (feeling tired)

Vomiting Sore mouth Blood in stool  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099 File in Section 4: Protocol Consent  
STUDY NUMBER: 14-C-0156 CONTINUATION: page 10 of 17 pages  
Jaundice (yellowing of the skin) Skin infections Urinary tract infection Fainting Nose bleed Rare but Serious Pneumonia

There is a potential risk of a condition called serotonin syndrome for patients who use certain medications from a class of drugs known as selective serotonin reuptake inhibitors (SSRIs) at the same time they're taking the study drug LY2606368. Serotonin syndrome is a potentially life threatening drug reaction that causes the body to have too much serotonin, a chemical produced by nerve cells. Symptoms may include, but are not limited to, agitation or restlessness, severe diarrhea, a fast heartbeat, and high blood pressure. Patients who use SSRIs will be closely monitored by their study doctor for any signs and symptoms of serotonin syndrome, and they should also be monitored for this condition by their home physician. Treatment and supportive care measures are available to manage serotonin syndrome.

There is a potential risk of developing irregular heartbeats on EKG, a condition called QTc prolongation, for patients who are taking the study drug LY2606368. This EKG change is a potentially life threatening event. People who have QTc prolongation on EKG are at risk of fainting and sudden death. Electrolytes abnormalities increase the risk for developing this change on EKG.  
Your electrolytes and EKG will be closely monitored before and after the study drug LY2606368 during the first two months, and then every 3 months until the end of treatment. Treatment and supportive care measures are available to manage QTc prolongation.  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099 File in Section 4: Protocol Consent  
STUDY NUMBER: 14-C-0156 CONTINUATION: page 11 of 17 pages

This research study involves exposure to radiation from up to 3 CT scans that may be used during your tumor biopsies. This radiation exposure is not required for your medical care and is for research purposes only. The amount of radiation you will receive in this study is 2.4 rem which is below the guideline of 5 rem per year allowed for research subjects by the NIH Radiation Safety Committee. The average person in the United States receives a radiation exposure of 0.3 rem per year from natural sources, such as the sun, outer space, and the earth's air and soil. If you would like more information about radiation, please ask the investigator for a copy of the pamphlet, An Introduction to Radiation for NIH Research Subjects. While there is no direct evidence that the amount of exposure received from participating in this study is harmful, there is indirect evidence it may not be completely safe. There may be a very slight increase in the risk of cancer. Please tell your doctor if you have had any radiation exposure in the past year, either from other research studies or from medical tests or care, so we can make sure that you will not receive too much radiation. Radiation exposure includes x-rays taken in radiology departments, cardiac catheterization, and fluoroscopy as well as nuclear medicine scans in which radioactive materials were injected into your body. If you are pregnant you will not be permitted to participate in this research study. It is best to avoid radiation exposure to unborn infants since they are more sensitive to radiation than adults.

The aim of this study is to see if this LY2606368 will cause your tumors to shrink. We do not know if you will receive personal, medical benefit from taking part in this study. These potential benefits could include shrinking of your tumor or lessening of your symptoms, such as pain, that are caused by the cancer. Because there is not much information about the drug's effect on your cancer, we do not know if you will benefit from taking part in this study, although the knowledge gained from this study may help others in the future who have cancer.
Clinical trial: NCT02203513
Section: Procedures
Subsections: What Will Happen If You Take Part In This Research Study?|Ly260368 Therapy|What Tests Will Be Done On My Samples?|Tumor Biopsy|Blood Sampling

This study consists of the following parts:  
A screening period that may last up to 30 days, during which tests will be done to see if you qualify to take part in the study.  
A treatment period consists of 28 day cycles during which you will be given study drug once every 14 days (day 1 and day 15 of every cycle). This treatment period will continue until up to 2 cycles after your cancer goes away, until your cancer gets worse, or if you are withdrawn from the study. If you cannot tolerate LY2606368, it may also be necessary to end your treatment.  
An end of treatment visit (for safety reasons) will be done after the last dose of study drug.  
If your cancer completely goes away, you will be followed every 4 weeks with noninvasive imaging performed every 12 weeks until your cancer returns, gets worse, or if you are withdrawn from the study.

You will receive the study drug LY260368 through an infusion in your vein over approximately one hour on Day 1 and on Day 15 of each 28-day cycle. Therapy will be continued every 14 days until your cancer goes away, until your cancer gets worse, or until you are withdrawn from the study. Your vital signs will be assessed 30 minutes before and after you have received the study drug. An EKG will be done within 1 hour after you have received the study drug.  
| PATIENT IDENTIFICATION   | CONTINUATION SHEET for either:  NIH-2514-1 (07-09)  NIH-2514-2 (10-84)  P.A.: 09-25-0099  File in Section 4: Protocol Consent   |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------|  
STUDY NUMBER: 14-C-0156 CONTINUATION: page 4 of 17 pages

In addition to the tests that we will conduct to determine whether you are having side effects or if you are responding to the study therapy, we will also collect samples from you for purposes of research only. All of your samples collected for research purposes on this study (such as the tumor and normal tissue) may be used to look for specific changes in the DNA in tumors that could be used to develop new ways of diagnosing and treating cancer. DNA (also called deoxyribonucleic acid) in the cells carries genetic information and passes it from one generation of cells to the next - like an instruction manual. Normal tissue contains the DNA (instructions) that you were born with, DNA in tumor cells has changed - or mutated - and we think that change in the DNA is what causes tumors to form and to grow. To look at your DNA, we may do what is called "whole genome sequencing." This is where we will do special tests in the lab to look at the entire sequence, or order, of how your DNA is put together. This is what makes you unique. To determine which parts of the DNA have mutated, we will compare the DNA in your tumor cells to DNA from your normal cells. We will then analyze the results from similar tumors to see if there are any changes in the DNA that are common to a particular type of tumor. To examine the tumor and normal tissue we may use several different techniques depending on the type of tissue we collect. These could include growing cell lines (cells which keep dividing and growing in the laboratory, sometimes for years allowing us to continually study those cells), xenograft studies (placing or growing cells in another animal, such as mice), and looking in detail at the parts of the genes that produce specific proteins. However, you should know that the analyses that we perform in our laboratory are for research purposes only; they are not nearly as sensitive as the tests that are performed in a laboratory that is certified to perform genetic testing or testing for routine clinical care. For these reasons, we will not give you the results of the research tests done on your research samples in most cases. There may be exceptions to what we share with you. In the unlikely event that we discover a finding that is believed to be clinically important based on medical standards at the time that we first analyze your results, we will contact you. This could be many years in the future. We will ask you to have an additional tube of blood drawn to verify the findings we have seen in our lab. If the results are verified, you will be re-contacted and offered a referral to a genetic healthcare provider to discuss the results. In the event that you are removed from this study before such findings become available, you must be enrolled on a follow-up study in order for us to contact you. This will enable us to maintain updated contact information for you and contact you when such findings become available.  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099 File in Section 4: Protocol Consent  
STUDY NUMBER: 14-C-0156 CONTINUATION: page 8 of 17 pages

If your doctor determines it is safe we will obtain a piece of your tumor (biopsy) using a needle with minimal risk to you. You will be given local anesthesia (numbing medicine) and a sedative prior to the biopsy. The biopsy will be taken through a needle put through the skin into your tumor. Depending upon the location of your tumor, a CT scan may be used to assist the biopsy. After the procedure the nurses will watch your blood pressure and other vital signs. This biopsy is not optional and you cannot participate in this study if you do not agree to the biopsy. If the first biopsy is too difficult or if you experience too much discomfort as a result of it you will be able to continue on the protocol without undergoing the second and third biopsies, which are optional. However, an attempt at the first biopsy is needed to enter this study. There are other studies at NIH which may also be options for you and which do not involve biopsies. For group 5, the second biopsy at progression is mandatory for those who responded to LY2606368 longer than 4 months.

Risks of blood sampling include bruising or bleeding at the needle site; rarely infection. This is treated with bandages, pressure and, if infection, antibiotic medicines. For more information about risks and side effects, ask your study team.  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099 File in Section 4: Protocol Consent  
STUDY NUMBER: 14-C-0156 CONTINUATION: page 12 of 17 pages
Clinical trial: NCT02203513
Section: Purpose of Research
Subsections: Why Is This Study Being Done?

The main purpose of this study is to see whether an investigational drug, LY2606368, will help to shrink tumors in people with certain types of breast and ovarian cancer. LY2606368 is manufactured by Eli Lilly and is not approved by the United States (U.S.) Food and Drug Administration (FDA) to treat any type of breast or ovarian cancer, or any other type of disease. All cells go through cycles which allow them to divide. Cell division is important because it allows all living things to grow, to heal and to reproduce. In normal cells, there are many proteins which help to make sure that cells are dividing correctly. LY2606368 blocks two of these proteins called Chk1 and Chk2. In normal cells, Chk1/2 stop cell division at various points to allow any damage  
PATIENT IDENTIFICATION CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH **STUDY**  
- Adult Patient or - Parent, for Minor Patient  
NIH-2514-1 (07-09)  
P.A.: 09-25-0099  
File in Section 4: Protocol Consent (1)  
STUDY NUMBER: 14-C-0156 CONTINUATION: page 2 of 17 pages to DNA to be repaired and to make sure that chromosomes are lined up correctly. When Chk1/2 are not present, cells stop dividing and eventually die. The researchers in this study hope that by blocking these proteins it will cause tumor cells to die, thereby shrinking tumors.
Clinical trial: NCT02203513
Section: Voluntary Participation
Subsections: Why Are You Being Asked To Take Part In This Study?

You are being asked to participate in this study because you have been diagnosed with:
1) Breast or ovarian cancer and have a mutation in BRCA1/2 genes (BRCAm)  
2) High Grade Serious Ovarian Cancer (HGSOC) OR 3) Triple Negative Breast Cancer (TNBC) OR
4) Recurrent platinum-resistant High Grade Serious Ovarian Cancer (HGSOC) AND  
5) All other standard measures have failed to cure your cancer.
How many people will take part in this study? About 153 people will take part in this research study. Description of Research Study
Clinical trial: NCT02203513
Section: Withdrawal from Study
Subsections: Stopping Therapy

Your doctor may decide to stop your therapy for the following reasons:
if he/she believes that it is in your best interest if your disease comes back during treatment if you have side effects from the treatment that your doctor thinks are too severe if new information shows that another treatment would be better for you If the study drug is no longer available
In this case, you will be informed of the reason therapy is being stopped. You can stop taking part in the study at any time. However, if you decide to stop taking part in the study, we would like you to talk to the study doctor and your regular doctor first. If you decide at any time to withdraw your consent to participate in the trial, we will not collect any additional medical information about you. However, according to FDA guidelines,  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099 File in Section 4: Protocol Consent  
STUDY NUMBER: 14-C-0156 CONTINUATION: page 13 of 17 pages information collected on you up to that point may still be provided to Eli Lilly or designated representatives. If you withdraw your consent and leave the trial, any samples of yours that have been obtained for the study and stored at the NCI can be destroyed upon request. However, any samples and data generated from the samples that have already been distributed to other researchers or placed in the research databases cannot be recalled and destroyed.