Clinical trial: NCT01989546
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: NCT01989546
Section: Confidentiality
Subsections: Will Your 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. 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.  
National Institutes of Health Institutional Review Board.  
Pharmaceutical Collaborator.
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: NCT01989546
Section: Duration of Study Involvement
Subsections: During The Study|When You Are Finished Taking The Drugs|From May 06, 2019 Through May 06, 2020.

If you are accepted and you choose to take part, you will begin receiving talazoparib (BMN 673). You will take talazoparib (BMN 673) by mouth once per day for 28 days. The drug is given in cycles; each cycle is 28 days (4 weeks) long. You can take the drug with or without food. You will be asked to maintain a diary to document the exact time you took the study drug, and to report any side effects that you may have. If you miss or vomit the dose, please make a note of this in your diary and contact your team immediately to receive further instructions. Please bring the study diary with you to each clinic visit. You will also have tests and procedures done because you are in the study to see how talazoparib (BMN 673) is affecting your body. This will include repeating some of the imaging studies (e.g., CT scans, a computerized x-ray examination) every 8 weeks to find out if your cancer has responded. Descriptions of the tests and procedures that will be performed during the study are listed below. Please see the Study Chart below for more details. Clinical Center Visits: We will ask that you come to the Clinical Center at the beginning of cycle 1, and weeks 1, 2, and 3 during cycle 1; and at the beginning of week 1 for all other cycles. While you are at the Clinical Center we will perform study tests and procedures to see how the study drug is affecting your body. If you develop any side effects, you may be asked to visit more often. Standard procedures being done because you are in this study; these may be done more

When you have finished taking talazoparib (BMN 673), your study doctor will watch you carefully for up to 30 days after the last treatment or until another treatment is started. You will need these tests and procedures at that time:
Vital signs and a physical examination Blood tests CT scans or other imaging tests such as ultrasound or MRI
You will be followed for 30 days after taking the last dose of study drugs. We will call you between days 27-30 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 in another study or start receiving standard therapy.

Signature of Investigator Date Signature of Witness Date Print Name Print Name PATIENT IDENTIFICATION CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH
STUDY (Continuation Sheet)
- Adult Patient or •Parent, for Minor Patient NIH-2514-1 (07-09) P.A.: 09-25-0099 File in Section 4: Protocol Consent
Clinical trial: NCT01989546
Section: Participant Responsibilities
Subsections: Complete Medical History.|Birth Control

**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:** A blood test will be done to check for pregnancy in women who are able to become pregnant.  
**CT scans:** of your chest, abdomen, and pelvis to measure your tumor(s). Other imaging tests may be done as needed.

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. 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 30 days after you finish study treatment. Men participating in this study must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 3 months after finishing 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)
vasectomy  tubal ligation 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  
  
  
for 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 NUMBER: 14-C-0015 CONTINUATION: page 7 of 14 pages
Clinical trial: NCT01989546
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.  
The NCI will supply the talazoparib (BMN 673) at no charge while you take part in this study. The NCI does not cover the cost of getting the talazoparib (BMN 673) ready and giving it to you, so you or your insurance company may have to pay for this.  
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  
  
  
Even though it probably won't happen, it is possible that the manufacturer may not continue to provide the talazoparib (BMN 673) to the NCI for some reason. If this would occur, other possible options are: - You might be able to get the talazoparib (BMN 673) from the manufacturer or your pharmacy but you or your insurance company may have to pay for it.  
- If there is no talazoparib (BMN 673) available at all, no one will be able to get more and the study would close.  
If a problem with getting talazoparib (BMN 673) occurs, your study doctor will talk to you about these options.
Clinical trial: NCT01989546
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Often Because You Are In The Study:|Risks Or Discomforts Of Participation What Side Effects Or Risks Can I Expect From Being In This Study?|Risks And Side Effects Related To Talazoparib (Bmn 673) May Include: Common, Some May Be Serious|Occasional, Some May Be Serious|Rare, And Serious|Potential Risks Related To Research-Related Imaging Studies:|Potential Benefits Of Participation Are There Benefits To Taking Part In This Study?

**Clinic visit:** to ask how you are feeling and to evaluate you with a physical examination during weeks 1 and 2 of cycle 1 and week 1 for all subsequent cycles.  
**Vital signs and physical examinations:** will be performed during the clinic visits.
**Blood tests:** Measurement of your white blood cells, red blood cells, platelets, blood sugar, electrolytes, and of how your liver and kidneys work will be done during weeks 1, 2, and 3 of cycle 1; and then at the beginning of all subsequent cycles. Approximately 1 tablespoon (15 mL) of blood will be drawn per visit.  
**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 before the study and every 8 weeks while you are receiving study drugs. This is done so that any benefit of the treatment can be determined, and if your cancer is not responding to the treatment, the study team can tell you and discuss other treatment options (discussed further below).

You may have side effects while on this 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 talazoparib (BMN 673). 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 drug. 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.

In 100 people receiving talazoparib (BMN 673), more than 20 and up to 100 may have:
Anemia which may require blood transfusion Diarrhea, nausea, vomiting Tiredness Bruising, bleeding Headache Hair loss

In 100 people receiving talazoparib (BMN 673), from 4 to 20 may have:
Pain Constipation, heartburn Sores in the mouth which may cause difficulty swallowing Fever Infection, especially when white blood cell count is low Loss of appetite Dizziness

In 100 people receiving talazoparib (BMN 673), 3 or fewer may have:  
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  
  
  
Swelling of the bowels which may require surgery Cancer of bone marrow caused by chemotherapy Damage to the bone marrow (irreversible) which may cause infection, bleeding, may require transfusions A new cancer resulting from treatment of earlier cancer
Because many of the adverse events seen in patients taking talazoparib (BMN 673) were decreased numbers of the cells you need to fight infection, please tell your study team immediately if you have any of the symptoms of a fever, sore throat, or other signs of an infection.

This research study involves exposure to radiation from up to 3 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 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.

Taking part in this study may or may not make your health better. 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  
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  
  
  
  
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: NCT01989546
Section: Procedures
Subsections: Description Of Research Study What Will Happen If You Take Part In This Research Study? Before You Begin The Study|Tests And Procedures That Are Either Being Tested In This Study Or Being Done To See How The Drug Is Affecting Your Body:

You will need to have the following examinations, tests, or procedures to find out if you can be in the study. Most of these examinations, tests, or procedures are part of your regular cancer care and may 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. You will have the examinations, tests, and procedures listed below to see if you can take part in the study (this is called the screening or baseline evaluation).

**Research blood samples:** We will collect blood samples to find out the effects of the drug on any tumor cells in the blood. Blood samples will be collected at the beginning of the study and then several times during cycle 1 and cycle 2, and at the start of all other cycles. Please see the study chart for more details. The total blood for all these tests will be about 7 tablespoons (100 mL).  
**Tumor biopsy:** 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 after you have taken the drug on day 8. We are collecting biopsy samples to study the effects of talazoparib (BMN 673) on your tumor. Biopsies are an important part of this trial and are done for research purposes. Willingness to undergo tumor biopsies is required for taking part in this study. We may also ask you for an optional third biopsy if your disease comes back during treatment. After the first 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. You will be asked to sign a separate consent form for each biopsy procedure. Tumor biopsies are only collected by trained personnel. Biopsies are collected using a small 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. The biopsy to be performed is exclusively for research purposes and will not benefit you. It might help other people in the future. Even if you sign "yes" to have the biopsy 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. I agree to allow biopsies for research purposes: Yes No Initials_________
Clinical trial: NCT01989546
Section: Purpose of Research
Subsections: Why Is This Study Being Done?

We are doing this study to develop better treatments for cancer. In this study, an experimental drug, **talazoparib (BMN 673)**, will be given to you. The purpose of this study is to determine what effects, good and/or bad, this drug may have on you and your cancer. This study will also look at how talazoparib (BMN 673) may affect the levels of certain proteins in your tumor and how well the drugs work against cancer cells by examining cells from a small piece of your tumor taken before the drug is given and again after talazoparib (BMN 673) is given.  
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)  
  
  
Talazoparib (BMN 673) is thought to work by preventing DNA repair in tumor cells. It is an experimental drug that has shown some anti-cancer effects against tumor cells in experimental animals and in patients with defects in their DNA-repair pathways. This drug is in the beginning stages of being tested in humans. About 600 patients have received talazoparib (BMN 673) to date. 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.
Clinical trial: NCT01989546
Section: Voluntary Participation
Subsections: Why Are You Being Asked To Take Part In This Study?

You are being asked to take part in this research study because you have ovarian or primary peritoneal carcinoma, breast carcinoma, or another type of cancer that has progressed after receiving standard treatment, or for which no effective therapy exists, and your tumor has a particular gene variation (a BRCA mutation) that changes how your tumor repairs DNA.
Clinical trial: NCT01989546
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.  
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  
  
  
  
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 agent manufacturer, Pfizer, 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.