Clinical trial: NCT01468922
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: NCT01468922
Section: Confidentiality
Subsections: Will My Medical Information Be Kept Private?

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, including research 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), involved in keeping research safe for people.  
- Qualified representatives from the pharmaceutical collaborator may also review the medical records.  
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: 12-C-0009 CONTINUATION: page 19 of 22 pages 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.
Clinical trial: NCT01468922
Section: Duration of Study Involvement
Subsections: During The Study|The Expansion Phase Will Start Only After The Dose Escalation Phase Has Been Completed. Your Study Doctor Will Tell You Which Phase Of The Study You Will Be In.|Follow-Up

After you are accepted for this study and you choose to take part, you will begin taking the study drugs pazopanib and ARQ 197. Pazopanib and ARQ 197 are taken by mouth. The study drugs will be given in cycles. All cycles are 4 weeks (28 days) long. This study has two parts, a dose escalation phase and an expansion phase. In the dose escalation phase, the doses of pazopanib and ARQ 197 will be escalated (increased) until the highest doses that can be safely given to humans are determined. These are the doses of study drugs will be given to patients in  
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: 12-C-0009 CONTINUATION: page 4 of 22 pages the expansion phase. Patients enrolled in the expansion phase will be given pazopanib alone for 1 week and then both drugs together.

If you are in the dose escalation phase, you will take pazopanib once a day and ARQ 197 twice a day about 12 hours apart, every day. You will receive a different dose based on when you entered the study. If you are in the expansion phase, you will take pazopanib only for the first week, and then both drugs together for the rest of the study. The study doctor may decrease your dose of study drug if you are not tolerating it well. Food may change the way your body handles pazopanib, so pazopanib should be taken with water at least 1 hour before or 2 hours after a meal. ARQ 197 should be taken with a meal. For example, on days when both drugs are taken, you should take pazopanib with only water when you wake up, then take the morning dose of ARQ 197 1 hour later with breakfast. Each day that you take study drugs, you will be asked to fill in a diary to show when you took the study drugs, how many pills you took, and report any side effects you may have had. For some study procedures we will need you to come to the Clinical Center. You will also have tests performed because you are in the study to see how the study drugs are affecting your body and to find out how your body handles the study drugs. This will include imaging studies (for example, CT scans) every 2 cycles (every 8 weeks) to find out if your cancer has responded.  
Clinical Center Visits: We will ask that you come to the Clinical Center for at least 3 days during the first cycle, and then at the beginning of each cycle. If you are enrolled in the dose escalation phase and choose to have a tumor biopsy, you will need to come to the Clinical Center for one more day during Cycle 1. During the first cycle only, you will be admitted to the Clinical Center for the first 2 days of drug administration to make it easier to collect research blood samples. For patients who have been on study for six or more cycles and are tolerating treatment well, clinic visits may be performed once every 2 cycles (every 2 months). Please see the study chart for more details. Standard procedures being done because you are in this study; these may be done more often because you are in the study:
- **Clinic visit** to ask how you are feeling and to evaluate you with a physical examination on multiple days during the first cycle and on the first day of each cycle from then on (cycles are 4 weeks long). For patients who have been on study for six or more cycles and are tolerating treatment well, clinic visits may be performed once every 2 cycles (every 2 months). Please see the study chart for more details.  
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: 12-C-0009 CONTINUATION: page 5 of 22 pages
- **Vital signs:** You will need to have your vital signs measured each time you are seen in the outpatient clinic.  
We will ask that you buy a blood pressure monitor (the cost of may be reimbursed to you; discuss with your study team) and measure your own blood pressure at home at least once a day (preferably twice a day) throughout the study. You will record the readings in a diary. If your systolic blood pressure (top number) is ever more than 150 or your diastolic blood pressure (bottom number) more than 90, you should re-measure your blood pressure 1 to 4 hours later. If your systolic pressure is still greater than 150 or your diastolic blood pressure is still greater than 90, please contact your study team for instructions. You should also call the research team if you experience any symptoms of high blood pressure, such as chest pain, shortness of breath, headache, blood in the urine, or double vision.  
- **Blood tests:** Measurement of your white blood cells, red blood cells and platelets, and measurements of your blood sugar and electrolytes and of how your liver and kidneys work will be done each time you are seen in the outpatient clinic. You may need blood tests more often if the study doctor thinks they are needed to check for signs of possible damage to your liver. All of these blood tests combined will require 1-2 tablespoons (2030 mL) of blood each time.  
- **Urine test** to check urine protein will be done during the first cycle and then before you start each new cycle. For patients who have been on study for six or more cycles and are tolerating treatment well, urine tests may be performed once every 2 cycles (every 2 months). Please see the study chart for more details. You may need it more frequently if the study doctor thinks it is needed to check for signs of possible damage to your kidneys. Depending on the results of urine tests, you may be asked to collect your urine for 24 hours for further testing.  
- **EKG** to check your heart will be done on multiple days during the first cycle. Some patients will have EKG on day 1 of Cycle 2. Please see the study chart for more details. You may need it more frequently if the study doctor thinks it is needed to check for signs of possible damage to your heart.  
- **CT scans** or other imaging tests such as ultrasound (an examination using sound waves)
or MRI (an examination using magnetic field and radio waves) that detect your tumor will be done every 2 cycles (about every 8 weeks) while you are receiving treatment. This is done so that any benefit of the treatment can be determined, and so that if your cancer is not responding to the treatment, the study team can tell you and help you move to a different treatment program (discussed further below).  
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: 12-C-0009 CONTINUATION: page 6 of 22 pages Tests and procedures that are either being tested in this study or being done to see how the study is affecting your body:
- Measurement of pazopanib and ARQ 197 **in your blood:** You will be admitted to the Clinical Center for the first 2 days of drug administration to make it easier to collect research blood samples. This will help us find out how your body handles the drugs. Blood will be collected during Cycle 1 at multiple time points. Please see the study chart for more details. The total blood for these tests will be about 4-5 tablespoons (about 50-66 mL). These research blood tests are mandatory and will be required for every patient.  
- Measurements **of the drugs' effects in your blood:** We will collect blood samples to examine the effects of the study drugs on targets in your blood at multiple time points during Cycle 1 and once before Cycle 2. Please see the study chart for more details. The total blood for all research tests will be less than 2 tablespoons (about 20 mL). These research blood tests are mandatory and will be required for every patient.  
- **Other research blood samples:** We will also collect a small amount of blood (10 mL) to test whether you have a variation in a certain gene and see if this has an effect on how your body handles the drugs. This research blood test is mandatory and will be required for every patient.  
- **Tumor biopsies:** During the dose escalation phase, tumor biopsies will be optional; however, in the expansion phase, patients will be required to undergo research tumor biopsies to take part in the study. Your study doctor will discuss this with you. Only if you have disease that in the opinion of your study doctor can be safely biopsied, will you be eligible to take part in the expansion phase. We will tell you if biopsies are required before you decide to take part in the study.  
After you are accepted to take part in the study, you will be asked to undergo imaging-directed biopsy of your tumor (removal of a small bit of tissue for microscopic examination) once before you receive the study drug and a second time after you receive the study drug on day 7 or 8 of Cycle 1. Biopsies are a very important part of this trial and are done for research purposes.  
Evaluating the tumor biopsies will help your study doctors understand how the drug works on tumor cells. Tumor biopsies are optional during the dose escalation phase. In the expansion phase, after the initial biopsy, if you decide not to have further biopsies, you will still receive study drugs and have other tests that are part of the study. Trained personnel will perform these biopsies. If any complication occurs, we will offer medical care. If upon attempting the first biopsy procedure, no tissue can be obtained or it has caused you harm, the second biopsy procedure will not be done. After you are enrolled in this study, if for any reason the biopsies cannot be done safely, you can still receive the study drugs but the biopsies will not be performed.  
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: 12-C-0009 CONTINUATION: page 7 of 22 pages Biopsies will be done using a small bore needle under imaging guidance (CT, MRI, or ultrasound as deemed appropriate by the interventional radiologist performing the biopsy). Imaging helps the specialized radiologist know that the needle has been placed into the tumor mass. You will be given an anesthetic to numb the area around where the needle is placed. Typical risks of such procedures include, but are not limited to, bleeding, infection, pain, and scarring. You will be counseled in more detail about the procedure, and you will be asked to sign a separate consent form that will describe the procedure and its risks at that time. Your safety is the most important thing at all times. The biopsies are for research purposes and will not benefit you. They might help other people in the future. Even if you sign "yes" to have biopsies, you can change your mind at any time. Please read the sentence below and think about your choice. After reading the sentence, circle and initial the answer that is right for you.  
1) Have you been informed that you will be in the dose escalation phase in this study? Yes No Initials_________ I agree to have the tumor biopsies for the escalation phase of the research study (optional).  
Yes No Initials_________
2) Have you been informed that you will be in the expansion phase in this study? Yes No Initials_________ I agree to have the tumor biopsies for the expansion phase of the research study (mandatory).  
Yes No Initials_________  
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: 12-C-0009 CONTINUATION: page 8 of 22 pages

You will be followed for 30 days after taking the last dose of study drug. We will call you after about 30 days to ask about any side effects that were ongoing when you stopped therapy, or any new side effects that might be related to the study therapy. If you have side effects that might be related to the study drugs that have not gotten better after 30 days, we will call you every 2 weeks until the side effects have become stable or gotten better. The follow-up period will end if you enroll on another protocol or start receiving standard therapy.
Clinical trial: NCT01468922
Section: Participant's Rights
Subsections: Research Subject'S Rights What Are My Rights If I Take Part In This Study?

Taking part in this study is your choice. You may choose either to take part or not to take part in this study. If you decide to take part, 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 if you are eligible and choose to participate in another trial. We will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study. 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: NCT01468922
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks Or Discomforts Of Participation What Side Effects Or Risks Can I Expect From Being In This Study?|Common, Some May Be Serious|Rare, And Serious|Occasional, Some May Be Serious|Reproductive Risks:|Side Effects Of Blood Draw:|Potential Risks Related To Research-Related Imaging Studies:|Potential Benefits Of Participation Are There Benefits To Taking Part In This Study?

You may have side effects while on the study. Everyone taking part in the study will be watched carefully for any side effects. But, doctors do not know all the side effects that may happen when taking pazopanib and ARQ 197 together. There may be other side effects that we cannot predict. 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 with those medicines, and others can go away soon after you stop taking the study drugs. In some cases, side effects can be serious, long lasting, may never go away, or may result in death. You should talk to your study team about all side effects that you have while taking part in the study. High blood pressure is one common side effect of pazopanib. Your blood pressure will be closely watched while you are taking pazopanib. This will include having your blood pressure measured every 2 weeks by a health care provider for the first 2 cycles in the dose escalation phase, or on day 1 and day 8 of cycle 1 in the expansion phase, then at least every cycle for the duration of treatment. You will also be checking your blood pressure at home at least once a day (preferable twice a day) for the entire study. If you have high blood pressure while taking pazopanib, your study doctor may recommend follow-up with your primary care physician and/or starting or increasing medication to lower blood pressure. Grapefruit juice has been shown to affect how the body handles some drugs by blocking the activity of the body's cytochrome P450 (CYP450) system. CYP450 is important in breaking  
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: 12-C-0009 CONTINUATION: page 13 of 22 pages down substances in the body, including pazopanib and many other drugs. Therefore, please avoid grapefruit juice or grapefruit while taking pazopanib. Acetaminophen and the herbal supplement St. John's wort can also affect blood levels of drugs such as pazopanib, so these should be avoided. Taking pazopanib can increase blood levels of drugs used to lower blood sugar. If you are taking medicine to lower your blood sugar, discuss with this your study doctor. You should check your blood sugar regularly during the study and contact the study team if your blood sugar is too low or if you have symptoms of low blood sugar. We do not know if taking pazopanib will cause other drugs you may be taking to work differently. It is very important that you talk to a member of the research team before beginning any new drugs, over-thecounter medications, vitamins, or alternative therapies.  
Risks and side effects related to **pazopanib** may include:

In 100 people receiving pazopanib, more than 20 may have:
- Diarrhea, nausea, vomiting
- Tiredness - Bruising, bleeding
- Infection, especially when white blood cell count is low
- Loss of appetite
- Change in hair color
- High blood pressure which may cause blurred vision OCCASIONAL, SOME MAY BE SERIOUS
In 100 people receiving pazopanib, from 4 to 20 may have:
- Anemia which may require blood transfusion
- Abnormal heartbeat
- Pain
- Constipation, heartburn
- Sores in mouth which may cause difficulty swallowing - Swelling of arms, legs
- Fever
- Weight loss - Dehydration
- Dizziness, headache
- Changes in taste - Cough, shortness of breath
- Internal bleeding which may cause coughing up blood, black tarry stool, or blood in vomit
- Bleeding from multiple sites including the nose - Hair loss, rash, skin changes
- Redness, pain or peeling of palms and soles  
| -                      | Hair loss, rash, skin changes                                                                                             |
|------------------------|---------------------------------------------------------------------------------------------------------------------------|
| -                      | Redness, pain or peeling of palms and soles                                                                               |
| 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: 12-C-0009 CONTINUATION: page 14 of 22 pages

In 100 people receiving pazopanib, 3 or fewer may have:
- Anemia, kidney problems which may require dialysis
- Blood clot which may cause confusion, paralysis, swelling, pain, or shortness of breath
- Heart failure, heart attack which may cause shortness of breath, swelling of ankles, and tiredness
- A tear or hole in internal organs that may require surgery
- Liver damage which may cause yellowing of eyes and skin
- Change in the heart rhythm
- Brain damage which may cause headache, seizure, blindness (also known as Reversible Posterior Leukoencephalopathy Syndrome)
- Kidney damage which may require dialysis
- Swelling or scarring of the lungs which may cause shortness of breath Risks and side effects related to **ARQ-197** so far include:

In 100 people receiving ARQ 197, from 4 to 20 may have
- Anemia which may require blood transfusion - Abnormal heartbeat - Diarrhea, nausea, vomiting
- Tiredness
- Infection, especially when white blood cell count is low
- Loss of appetite
- Rash RARE, AND SERIOUS
In 100 people receiving ARQ 197, 3 or fewer may have
- Redness, pain or peeling of palms and soles  
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: 12-C-0009 CONTINUATION: page 15 of 22 pages

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 the combination of these medicines would affect your baby or your unborn child. 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 treatment, during study treatment, and for 2 months after you finish study treatment. 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)
- tubal ligation - vasectomy
- hormonal [injections, or implants]: estrogen containing pills are not allowed due to the risk of blood clotting

Infrequent (occurs in 1 to 10 out of 100 people): persistent pain and discomfort at the injection or needle insertion site as well as possible infection, bleeding, bruising, and soreness.

This research study involves exposure to radiation from up to 2 CT scans (used in biopsy collections). 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 0.29 rem, which is below the guideline of 5 rem (or 0.5 rem in children) 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.  
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: 12-C-0009 CONTINUATION: page 16 of 22 pages

Taking part in this study may or may not make your health better. We hope that you will get personal medical benefit from taking part in this study, but there is no proof of this yet. These potential benefits could include shrinking of your tumor or lessening of your symptoms, such as pain, that are caused by the cancer. You should discuss other treatment options with the study team and your home doctor before deciding to take part in this study. We do know that information from this study will help doctors learn more about these study drugs. This information will also help future cancer patients.
Clinical trial: NCT01468922
Section: Procedures
Subsections: - **Complete Medical History.**

- **Physical examination,** including height, weight, blood pressure, pulse, and temperature.  
- **Standard blood** tests (requiring about 1 tablespoon of blood in total), which include measurement of your white blood cells, red blood cells, platelets, blood sugar and electrolytes, how your liver and kidneys work, and how well your **blood** clots.  
- **Pregnancy test** in women who are able to become pregnant.  
- **Urine tests:** A urine test will be done to check the level of protein excreted by your kidneys. Depending on the results of blood tests, you may be asked to collect your urine for 24 hours for further testing.  
- EKG and echocardiogram or MUGA scan to check your heart.  
- **CT scans** of your chest, abdomen, and pelvis to measure your tumor(s). Other imaging tests may be done as needed.
Clinical trial: NCT01468922
Section: Purpose of Research
Subsections: Why Is This Study Being Done?|Why Are You Being Asked To Take Part In This Study?|Description Of Research Study

We are studying two drugs in this trial, **pazopanib** and **ARQ 197**. The use of pazopanib and ARQ 197 together is experimental. Pazopanib works by blocking the formation of new blood vessels in tumors, a process called angiogenesis. New blood vessels provide oxygen and nutrients to growing cancers, and blocking this process can cause cancer cells or the supporting blood vessels to stop growing. Pazopanib is approved by the United States Food and Drug  
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: 12-C-0009 CONTINUATION: page 2 of 22 pages Administration (FDA) for treating patients with renal cell carcinoma. ARQ 197 (tivantinib) is an experimental drug that has shown some effects against tumor cells in the laboratory and in experimental animals. This drug works by blocking a protein called c-MET needed for cancer cells to grow and survive. In laboratory studies, some drugs that block angiogenesis increase the production of c-MET in tumors, which helps cancer cells adapt to not having enough oxygen, so the tumor can keep growing. Blocking both angiogenesis and c-MET with pazopanib and ARQ 197 together may limit cancer cells' ability to survive. The purpose of this study is to test the safety of the combination of pazopanib and ARQ 197, and find out the doses of these drugs that can be safely given to humans. We are trying to understand how these drugs work in humans. For that, this study will look at how pazopanib and ARQ 197 may affect the levels of certain proteins in your tumor. To do this, we will look at cells from a small piece of tumor in some of the patients on this study before and after giving study drugs. Discuss with your study doctor whether you need to undergo tumor biopsies as part of this study. Although we hope this experimental therapy will decrease the size of your tumor, we cannot promise or predict the benefits of the treatment at this time. The drugs used in this study have known side effects that will be reviewed with you by your medical team before you sign the consent form.

You are being asked to take part in this study because there are no standard treatments that are very effective for the cancer you have. We hope that this combination of study drugs will slow down the growth of your cancer.

What will happen if you take part in this research study? Before you begin the study You will need to have the following examinations, tests, or procedures to find out if you can be in the study. These tests are part of your regular cancer care and should be done by your health care team even if you do not join the study. If you have had them recently, they may not need to be repeated. This will be up to your study doctor. If you decide that you would like to participate in this study, you will be asked to sign this consent form. You will then have the examinations, tests, and procedures listed below done to see if you can take part in the study (this is called the screening/baseline evaluation).
Clinical trial: NCT01468922
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 too many patients in the study experience severe side effects
- if you become pregnant
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, information collected on you up to that point may still be provided to the Cancer Therapy Evaluation Program (CTEP) at the National Cancer Institute (NCI) 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.  
STUDY NUMBER: 12-C-0009 CONTINUATION: page 18 of 22 pages