Clinical trial: NCT02312622
Section: Alternatives
Subsections: Alternatives

Joel W  MD,  
  
Protocol Title: A Phase II Study of Etirinotecan Pegol (NKTR 102) in Patients with Refractory Brain Metastases and Advanced Lung Cancer or Metastatic Breast Cancer (MBC)
You do not have to be in this study to receive treatment for your lung or breast cancer.  
The Protocol Director will talk to you about other things you can do for you lung or breast cancer, which may include  
Standard treatment Other experimental therapy No further anti-cancer therapy and comfort care only.
Please talk to your regular doctor about these options. You can continue to get care from your doctor even if you do not take part in this study
Clinical trial: NCT02312622
Section: Confidentiality
Subsections: Confidentiality|Authorization To Use Your Health Information For Research Purposes|What Personal Information Will Be Obtained, Used Or Disclosed?|Who May Use Or Disclose The Information?|Who May Receive Or Use The Information?

The results of this research study may be presented at scientific or medical meetings or published in scientific journals. Your identity and/or your personal health information will not be disclosed except as authorized by you or as required by law. However, there is always some risk that even de-identified information might be re-identified. Your research records may be disclosed outside of Stanford, but in this case, you will be identified only by a unique code number. Information about the code will be kept in a secure location and access limited to research study personnel. Patient information may be provided to Federal and other regulatory agencies as required. The Food and Drug Administration (FDA), for example, may inspect research records and learn your identity if this study falls within its jurisdiction. The purpose of this research study is to obtain data or information on the safety and effectiveness of NKTR-102; the results will be provided to the drug manufacturer Nektar  
  
Joel W  MD,
Protocol Title: A Phase II Study of Etirinotecan Pegol (NKTR 102) in Patients with Refractory Brain Metastases and Advanced Lung Cancer or Metastatic Breast Cancer (MBC)
Therapeutics; the Food and Drug Administration (FDA); and other federal and regulatory agencies as required.  
  
Joel W  MD,  
  
  
  
Protocol Title: A Phase II Study of Etirinotecan Pegol (NKTR 102) in Patients with Refractory Brain Metastases and Advanced Lung Cancer or Metastatic Breast Cancer (MBC)

Because information about you and your health is personal and private, it generally cannot be used in this research study without your written authorization. If you sign this form, it will provide that authorization. The form is intended to inform you about how your health information will be used or disclosed in the study. Your information will only be used in accordance with this authorization form and the informed consent form and as required or allowed by law. Please read it carefully before signing it.

Your health information related to this study, may be used or disclosed in connection with this research study, including, but not limited to:
demographic information (name, address, contact information, gender, date of birth, ethnicity), medical condition, medical history, specific blood and urine tests, physical examination measures, diagnostic and medical procedures (x-rays, MRI, CT scan), and any reports such as radiology and pathology reports.

The following parties are authorized to use and/or disclose your health information in connection with this research study:
The Protocol Director, Joel Neal, MD, PhD Research Staff The Stanford University Administrative Panel on Human Subjects in Medical Research and any other unit of Stanford University as necessary

The parties listed in the preceding paragraph may disclose your health information to the following persons and organizations for their use in connection with this research study:
The Office for Human Research Protections in the US Department of Health and Human Services (DHHS)
Nektar Therapeutics, or their representatives The Food and Drug Administration (FDA) and/or other state or international regulatory authorities Your information may be re-disclosed by the recipients described above, if they are not required by law to protect the privacy of the information.
Clinical trial: NCT02312622
Section: Duration of Study Involvement
Subsections: Duration Of Study Involvement|End Of Study:|Follow Up:

Your time in this study will be determined by how well you respond to the treatment. In other words, your time on this study will be counted in treatment cycles. The number of cycles you receive will be based on the side effects you experience, how well your cancer responds to the study treatment and if the study doctor feels it is in your best interest to continue. You can also withdraw your consent at any time. This study will take approximately 36 months to enroll and treat all 27 patients.  
  
Joel W  MD,  
  
Protocol Title: A Phase II Study of Etirinotecan Pegol (NKTR 102) in Patients with Refractory Brain Metastases and Advanced Lung Cancer or Metastatic Breast Cancer (MBC)

Approximately 30 days after your last dose of NKTR-102, you will be asked to return to a final Study Visit. At this visit, you will have the same procedures performed as at a Treatment Visit (described above), except you will not have the NKTR-102 infusion, MRI or CT scan. If you are not able to come into the clinic for the visit, you may be contacted by phone.

After the end of study visit, the Study Team will continue to follow you for survival approximately every 3 months, unless you specifically withdraw your consent for this. This may include information from your continued visits to your doctor; review of your medical record; and/or phone calls to you. Collected information may include any subsequent anti-cancer therapy and disease progression.
Clinical trial: NCT02312622
Section: Participant Responsibilities
Subsections: Participant Responsibilities

As a participant, your responsibilities include:  
Follow the instructions of the Protocol Director and study staff. Be sure to tell the study staff all of your medical history, allergies and any drugs or medications you are taking. You should not take any new medicine while you are on this study unless you first check with the study staff.  
Ask questions as you think of them. Keep your study appointments. If it is necessary to miss an appointment, please contact the Protocol Director or research study staff to reschedule as soon as you know you will miss the appointment.  
Tell the Protocol Director or study team if you change your mind about staying in the study.  
Tell the Protocol Director or research study staff about any side effects, doctor visits, or hospitalizations that you may have.  
Tell the Protocol Director or research staff if you believe you might be pregnant or gotten your partner pregnant.
Clinical trial: NCT02312622
Section: Participant's Rights
Subsections: Participant'S Rights|Experimental Subject'S Bill Of Rights

You should not feel obligated to agree to participate. Your questions should be answered clearly and to your satisfaction. If you decide not to participate, tell the Protocol Director. You can also tell any other member of the study staff. You will be told of any important new information that is learned during the course of this research study, which might affect your condition or your willingness to continue participation in this study.

As a research participant you have the following rights. These rights include but are not limited to the participant's right to:  
Be informed of the nature and purpose of the experiment; Be given an explanation of the procedures to be followed in the medical experiment, and any drug or device to be utilized; Be given a description of any attendant discomforts and risks reasonably expected; Be given an explanation of any benefits to the subject reasonably to be expected, if applicable; Be given a disclosure of any appropriate alternatives, drugs or devices that might be advantageous to the subject, their relative risks and benefits; Be informed of the avenues of medical treatment, if any available to the subject after the experiment if complications should arise; Be given an opportunity to ask questions concerning the experiment or the procedures involved;
Joel W  MD,  
  
  
Protocol Title: A Phase II Study of Etirinotecan Pegol (NKTR 102) in Patients with Refractory Brain Metastases and Advanced Lung Cancer or Metastatic Breast Cancer (MBC)  
Be instructed that consent to participate in the medical experiment may be withdrawn at any time and the subject may discontinue participation without prejudice; Be given a copy of the signed and dated consent form; and Be given the opportunity to decide to consent or not to consent to a medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion or undue influence on the subject's decision.
May we contact you about future studies that may be of interest to you? ___Yes ___No Signing your name means you agree to be in this study and that you are given a copy of this signed and dated consent form. _______________________________________________ Printed Name of Participant _______________________________________________ ____________ Signature of Adult Participant Date
Clinical trial: NCT02312622
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks:|Possible Risks, Discomforts, And Inconveniences|Most Common Side Effects Of The Study Drug Nktr-102

Magnetic fields do not cause harmful effects at the levels used in the MRI machine. However, the MR scanner uses a very strong magnet that will attract some metals and affect some electronic devices. If you have a cardiac pacemaker or any other biomedical device in or on your body, it is very important that you tell the operator/investigator immediately. As metallic objects may experience a strong attraction to the magnet, it is also very important that you notify the operator of any metal objects (especially surgical clips), devices, or implants that are in or on your body before entering the magnet room.  
  
  
Joel W  MD,  
  
  
Protocol Title: A Phase II Study of Etirinotecan Pegol (NKTR 102) in Patients with Refractory Brain Metastases and Advanced Lung Cancer or Metastatic Breast Cancer (MBC)
All such objects must be removed (if possible) before entering the magnet room. In some cases, having those devices means you should not have an MRI scan performed. In addition, watches and credit cards should also be removed as these could be damaged. You will be provided a way to secure these items. If you have any history of head or eye injury involving metal fragments, if you have ever worked in a metal shop, or if you could be pregnant, you should notify the operator/investigator. You should also notify the operator/investigator if you have any tattoos on your body, including eyeliner and other permanent makeup. Tattoos could become warm and irritated during the scan and remain so for several days. If you would prefer not to participate in the MR scan due to the presence of tattoos on your body, please inform a research team member. If you have had a previous reaction to Gadolinium-based contrast agents or a history of severe allergies, please notify the operator/investigator. If you have kidney problems, please tell the operator. It has been observed that deposits of Gadolinium-based contrast agent (GBCA) remain in the brains of some people who undergo four or more contrast enhanced MRI scans, long after the last administration. It is not yet known whether these Gadolinium deposits are harmful or can lead to adverse health effects. You should talk to the study doctor if you have any questions about the use of GBCAs with MRIs

There are risks, discomforts, and inconveniences associated with any research study. These deserve careful thought. You should talk to the Protocol Director if you have any questions. You must tell the Study Doctor or study staff about all side effects that you have. If you are not honest about your side effects, it may not be safe for you to stay in the study.  
Your Study Doctor may give you medications to try to help lessen some of the side effects. All patients in the study will be monitored for side effects.

Severe and/or life-threatening diarrhea has been seen in 18% of patients who were given the study drug NKTR-102. Severe diarrhea resolved within an average of 14 days. It is very important to **avoid the use of any laxatives**, and if you feel you need to take a laxative, you must discuss it with your study doctor first. From the first NKTR-102 treatment onwards, you must have anti-diarrhea medicine, loperamide, available at home. It is very important not to take the anti-diarrhea medicine until you actually have experienced loose stools (diarrhea). More details about the medicine and how to take
Clinical trial: NCT02312622
Section: Procedures
Subsections: Procedures Before You Begin This Study:|During Study Treatment:

You must sign this consent form prior to doing any study specific tests or evaluations. You will need to have certain medical examinations, tests, or procedures to find out if you can be in the study. Some may be part of your regular medical care. If you have had some of these exams, tests or procedures done recently (within 21 days), they may not need to be repeated. The following will be done to see if you are eligible to join the study:
Medical and cancer history  
A review of all the medications you are currently taking, including all prescription and non-prescription medications (vitamins, herbal supplements, over the counter medications)
Physical examination and vital signs Blood (1 tablespoon) and urine samples will be collected for routine tests to evaluate liver, bone marrow, clotting, metabolic and kidney functions If you are a woman capable of having children, your blood will be tested to make sure you are not pregnant Brain MRI (Magnetic Resonance Imaging) and Body CT (Computed Tomography)

You will receive study drug NKTR-102 on Day 1 of each cycle. One cycle is 3 weeks, or 21 days, long. You will need to come to the study center on the first day of every cycle during all cycles to receive the dose of study drug NKTR-102. The study drug NKTR102 will be given through a needle into your vein slowly (intravenous [IV] infusion). This will take about 90 minutes. While you are receiving the study drug, NKTR-102, the study staff will watch you closely for any side effects you may have. If you are experiencing certain side effects, the dose of NKTR-102 may be reduced. Many of these tests are part of regular cancer care, but may be done more often because you are in the study.  
Physical Exam and vital signs Medical history will be reviewed and updated Blood (1 tablespoon) will be collected for routine tests to evaluate liver, bone marrow, metabolic and kidney functions. This may be done up to three days before the infusion
Clinical trial: NCT02312622
Section: Purpose of Research
Subsections: Purpose Of Research|What Is The Purpose Of This Research Study And How Will My Health Information Be Utilized In The Study?

You are invited to participate in a research study for lung and breast cancer that has spread to the brain (brain metastases) using an investigational chemotherapy drug called etirinotecan pegol (NKTR-102). You were selected as a possible participant in this study because your brain metastases are either refractory (grown after prior treatment) or you are not eligible for standard treatment. This research study is being done to see whether NKTR-102 is effective for treating lung and breast cancer with brain metastases. The use of NKTR-102 in this study is investigational. The word "investigational" means that NKTR-102 is not approved by the Food and Drug Administration (FDA) for this indication. However, the FDA is allowing the use of NKTR-102 as part of this research study. If you decide to terminate your participation in this study, you should notify Sophie Bertrand at 650-723-4467. This research study is looking for 27 people with lung cancer or breast cancer that has spread to the brain. This is a single-center study being conducted at Stanford University. This study is being paid for by Nektar Therapeutics, a biopharmaceutical company in San Francisco, California. They will be providing the study drug.

The purpose of this study is to examine the safety and effectiveness of NKTR-102 in lung or breast cancer with brain metastases. Your medical information is information about your physical and/or mental health condition. It includes your previous medical records and information created or collected during the study (for example, the results from various tests or examinations) and the medical information that will be collected from you if you participate in this study.
Clinical trial: NCT02312622
Section: Voluntary Participation
Subsections: Voluntary Participation|Do I Have To Sign This Authorization Form?

Your participation in this study is entirely voluntary. Your decision not to participate will not have any negative effect on you or your medical care. You can decide to participate now, but withdraw your consent later and stop being in the study without any loss of benefits or medical care to which you are entitled.

You do not have to sign this authorization form. But if you do not, you will not be able to participate in this research study, including receiving any research-related treatment.  
Signing the form is not a condition for receiving any medical care outside the study.
Clinical trial: NCT02312622
Section: Withdrawal from Study
Subsections: If You Feel Discomfort At Any Time, Notify The Operator And You Can Discontinue The Exam At Any Time.|Withdrawal From The Study|If I Sign, Can I Revoke It Or Withdraw From The Research Later?

A computed tomography (CT) **scan (an "X-ray")** with or without contrast may be performed according to standard practice. The CT scan will be used to look at the blood flow and the extent and activity of your cancer. This scan is part of your normal medical care. The scan will take about 30 to 60 minutes. You will need to remove all jewelry, piercings, and other metal items. A tourniquet will be applied to your arm or leg to help find a vein, and a contrast agent will be injected into a vein. The entire scan procedure will take about 30 to 60 minutes. You will be asked to lie still on a long narrow bench, or scanner bed, for up to 45 minutes. You will be asked not to move during the scan and to relax and breathe normally. A strap and/or pillows may be placed across your body to prevent movement. You may experience some discomfort or anxiety from being in the confined space. If this bothers you too much, the study team may provide you with a medication to help you stay calm. During the CT scan procedure, the scanner will rotate around you, and make clicking sounds, which is normal. Tell the CT technician immediately if you have any breathing difficulties; sweating; numbness; or heart palpitations.

If you first agree to participate and then you change your mind, you are free to withdraw your consent and discontinue your participation at any time. Your decision will not affect your ability to receive medical care for your disease and you will not lose any benefits to which you would otherwise be entitled. If you decide to withdraw your consent to participate in this study, you should notify Protocol Director Joel W Neal, MD, PhD, at 650-498-6000, or study coordinator Sophie Bertrand at 650-723-4467. To help you safely finish your participation in the study, the Study Doctors may ask you to come into the clinic for an End of Treatment Visit. The Study Doctors may also ask if you wish to take part in the follow-up portion of the study. If you agree, information  
Joel W  MD,  
  
  
Protocol Title: A Phase II Study of Etirinotecan Pegol (NKTR 102) in Patients with Refractory Brain Metastases and Advanced Lung Cancer or Metastatic Breast Cancer (MBC)
about your health will continue to be collected as described above in the Follow Up section The Protocol Director may also withdraw you from the study and the study medication may be stopped, without your consent for one or more of the following reasons:  
Failure to follow the instructions of the Protocol Director and study staff. The Protocol Director decides that continuing your participation could be harmful to you.  
If your tumor worsens (tumor progression).  
If you have serious side effects during treatment with Study Drug.  
You become pregnant.  
You need treatment not allowed in the study. The study is stopped by the drug manufacturer Nektar Therapeutics; the Stanford Institutional Review Board (the IRB, a group of people who review the research to protect your rights), or by a regulatory agency such as the US Food and Drug Administration (FDA).  
Other administrative reasons.  
Unanticipated circumstances.

If you decide to participate, you are free to withdraw your authorization regarding the use and disclosure of your health information (and to discontinue any other participation in the study) at any time. After any revocation, your health information will no longer be used or disclosed in the study, except to the extent that the law allows us to continue using your information (eg, necessary to maintain integrity of research). If you wish to revoke your authorization for the research use or disclosure of your health information in this study, you must write to:  
  
Joel W  MD,  
  
  
  
Protocol Title: A Phase II Study of Etirinotecan Pegol (NKTR 102) in Patients with Refractory Brain Metastases and Advanced Lung Cancer or Metastatic Breast Cancer (MBC)
Joel Neal, MD, PhD
875 Blake Wilbur Dr, Room 2220 Stanford, CA 94305-5826