Clinical trial: NCT03670030
Section: Alternatives
Subsections: Potential Benefits

You may not receive direct personal or health benefit from taking part in this study. However, the information gained from your participation in this study may be used to help others in the future.
Clinical trial: NCT03670030
Section: Confidentiality
Subsections: Confidentiality|Hipaa Authorization To Release Information For Research|Part In This Study Unless You Agree To This Authorization.|How May Study Information Identify Me?|Why Will This Study Information Be Used And/Or Shared?|How Long Is My Information Kept?

Your identity and your personal records will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available. Confidentiality will be maintained during and after your participation in this study. 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. The results of this research may also be published in scientific journals or presented at medical meetings, but your identity will not be disclosed.

Under federal law (the "Privacy Rule"), your Protected Health Information (PHI) that is created or obtained during this clinical research study cannot be "used" to conduct the research or "disclosed" (given to anyone) for research purposes without your permission. This permission is called an "Authorization". **Therefore, you may not take**

Before you agree to take part in the study, we want to tell you:
How study information may identify you Who may use or share your protected health information Why your protected health information will be used or shared Your rights concerning use and/or sharing of your protected health information

Study information may identify you in the following ways:
Name, address, telephone number Other details about you including your past medical records  
Medical information that identifies you and relates to your participation will be created, and may be used and/or shared, including information obtained from:
Study visits and phone calls Physical examinations, blood and urine tests, x-rays, and other procedures or tests Your response to any study treatments you receive Any other information that you may release to us, including information about your health history.  
Who may use or share my protected health information? The Investigator (study doctor) and research staff may give protected health information to others during and after the study, including:
The study sponsor, including any people or companies working for or with the sponsor or owned by the sponsor.  
Doctors and healthcare professionals taking part in the study Government agencies in the United States and in other countries Ochsner Clinic Foundation
Third party vendors as authorized by Ochsner Clinic Foundation

To carry out the research study To analyze and evaluate the results of the study To conduct internal research compliance reviews To comply with governmental reporting requirements To obtain marketing approval for new products

Ochsner Clinic Foundation policy requires that all files related to a research study are stored for ten (10) years after the research study has been closed at the Ochsner site.  
  
Do not sign this consent form unless you have had a chance to ask questions and have received satisfactory answers to all of your questions. If you agree to participate in this study, you will receive a signed and dated copy of this consent form for your records.
Clinical trial: NCT03670030
Section: Duration of Study Involvement
Subsections: Length Of Study And Number Of Participants|Follow-Up Period

You will remain on study drug until your disease gets worse or you or your doctor decide that the treatment is not right for you. After your last dose of study drug, you will be followed by phone every 3 months until you start a new treatment, withdraw consent, or the study closes. This study will only take place at Ochsner and will enroll 10 subjects.

Post-treatment survival time will be recorded about every 12 weeks (±3 weeks) from the end of treatment visit or more frequently as needed. This information will be recorded until death, withdrawal of consent, new anticancer therapy, or when the study closes, whichever is earliest. This evaluation may be by medical record review and/or telephone contact.
Clinical trial: NCT03670030
Section: Participant's Rights
Subsections: Questions About Your Rights|What Are My Rights Regarding My Health Information?

If you have questions about your rights as a research subject, you may contact:
Ochsner Clinic Foundation Institutional Review Board 1514 Jefferson Highway New Orleans, LA 70121 Telephone: 1-504-842-3535 Email: IRB@ochsner.org The Institutional Review Board (IRB) is a group of people who perform independent review of research for human subject protection. You may contact the IRB to discuss any problems, concerns or questions you have about research. The IRB can assist you in obtaining information about research and encourages input from research subjects.

You have the right to review and copy your health information. However, as a participant in this research study, you would not be allowed to look at or copy your information until after the research is completed.  
You may withdraw or revoke (cancel) your permission to use and disclose your health information at any time. However, unless you revoke your permission by sending written notice to the study doctor, this authorization (permission) will not expire (end) until it is no longer required by the Sponsor.  
When you withdraw your permission, no new health information that might identify you will be gathered after that date. Information that has already been gathered may still be used and given to others. This would be done if it were necessary for the research to be reliable. If you withdraw your permission, you will not be able to continue being in this study. Are there possible limitations on the protection of my health information?  
If your health information is given to the parties listed above and/or to others who are not required to comply with federal privacy laws, your information may no longer be protected, and there is a risk that your information will be released to others without your permission.  
Your personal information may be disclosed if required by law.  
Your records for this study may be sent by facsimile transmission (FAX) or over the Internet. It is possible that your records could be sent to the wrong person.
Clinical trial: NCT03670030
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks Risks From Abi-009, The Study Drug|Risks From The Study Procedures|General / Unforeseeable|Reproductive Risks|Radiation Risks

You may have side effects while you are in the study, but you will be carefully checked by the study doctor for any problems. There may be risks or side effects of the study drug that are unknown at this time. You should tell the study doctor/staff about anything that is bothering you or any side effects you have, even if you do not think they are related to the study drug. The following is a list of the most medically significant or most common side effects reported in previous or ongoing studies and considered to be related to ABI-009. In some cases, side effects can be serious or long-lasting. Some side effects go away soon after you stop the study drug/therapy, and some may take time to resolve. The study doctor may alter the dosage regimen of ABI-009 or give you medicines to help lessen the side effects. This is not a complete list of all side effects that may occur. For more information about risks and side effects, please ask the study doctor. Based on ABI-009 Investigator Brochure v7.0, the most common to uncommon side effects as follows:  
Approved  

Very common (>10% or more chance that this will happen, based on a previous study with ABI-009):
low blood platelets (thrombocytopenia) low blood hemoglobin (anemia)
low white blood cell count (neutropenia)
low potassium levels (hypokalemia) elevated lipid levels (hypertriglyceridemia)
elevated cholesterol (hypercholesterolemia)
elevated blood glucose (hyperglycemia)
diarrhea nausea vomiting constipation inflammation of the mucus membrane (mucosal inflammation)
fatigue decreased liver function (elevated AST) weight decrease rash dermatitis headache infection (including candidiasis, cellulitis, folliculitis, urinary tract)
decreased appetite (anorexia)
altered sense of taste (dysgeusia)
edema Common (between a 1% to less than 10% chance that this will happen):
low blood phosphate levels (hypophosphatemia)
increased amylase increased lipase low magnesium levels (hypomagnesemia) decreased liver function (elevated ALT) elevated creatinine levels low lymphocyte count cough labored breathing (dyspnea)
pneumonitis insomnia epistaxis dry mouth hair loss (alopecia) nail disorder muscle pain (myalgia)  
  
hypertension fever acute kidney injury failure to thrive enteritis (including ileitis, colitis)
weakness, numbness, or tingling in hand and feet (neuropathy) vertigo (dizziness)
Uncommon (between a 0.1 to less than 1% chance that this will happen):
elevated potassium levels (hyperkalemia) low sodium levels (hyponatremia)
low blood albumin levels pancytopenia alkalosis hypothyroidism dehydration odynophagia lip blister infusion site pain thirst suicidal ideas disorientations fast heart rate (tachycardia) transient chest pain (acute coronary syndrome)
ABI-009 contains human serum albumin. Human serum albumin presents a small risk of allergic or anaphylactic type reactions. Tell your doctor if you have ever had a reaction to human serum albumin. Human serum albumin is a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin. Sirolimus, also known as rapamycin, is known to be associated with the following potential risks after long term use:
testicular toxicities pulmonary toxicities (pneumonitis)
increased risk for cancer

Risk with Intravenous (IV) Drug Administration: Temporary irritation and bruising may occur at the infusion site. There may also be discomfort, pain, or bruising from the needle puncture. In rare cases, an infection may also occur at the site of the needle stick. Blood draws: Needle sticks carry some risks such as fainting, bleeding, bruising, discomfort, dizziness, infection and/or pain at the puncture site. CT and MRI Scans: As part of this study, you will have CT and MRI scans. CT scans involve exposure to radiation. Some people may be worried about the amount of radiation they receive during a CT scan. The amount of radiation from this entire study is well below the levels that are thought to result in a significant risk of harmful effects. Radiation exposure from a CT scan can be higher than from a regular x-ray. Some people experience mild itching or hives. Signs of a more serious allergic reaction include shortness of breath and swelling of the throat or other parts of the body, abdominal pain, or vomiting. You should tell the technologist immediately if you experience any of these symptoms, so you can be treated immediately. You may experience discomfort related to lying still in an enclosed space for a prolonged period of time while the CT scan or MRI is being taken.

There may be side effects and discomforts that are not yet known. You should tell your study doctor about any side effects you experience even if you think they are not related. Louisiana law requires us to set forth the known risks of a medical treatment, including the risks, if any, of death, brain damage, quadriplegia (paralysis in all arms and legs), paraplegia (paralysis of both legs), the loss or loss of function of any organ or limb, and disfiguring scars, which might be associated with a necessary procedure. Any clinical study carries with it risks of which we may be unaware at this time, including those listed in this paragraph.

No studies of ABI-009 have been conducted in pregnancy. It is not known if ABI-009 passes into milk during breast feeding Females: If you decide to take part in this study, and are able to have children, you must agree to use medical doctor-approved contraception plus a barrier contraceptive throughout the study, and for 3 months after your last dose of study treatment. In addition, if you have had your tubes tied (tubal ligation) you must also agree to use a second form of birth control. If you become pregnant while receiving study treatment you must tell the study doctor right away. If this happens, your participation in this study treatment will be discontinued. If you become pregnant within 3 months after taking your last dose of study drug you must tell the study doctor right away. The study doctor will follow you and your pregnancy to birth. Males: If you are a man, you will not be able to donate sperm for the length of the trial and for 3 months following treatment. If you have a partner able to have children, you must agree to use a medical doctor-approved form of contraception plus a barrier contraceptive throughout the study and should avoid fathering a child for 3 months after your last dose of study treatment. In addition, if you have had a vasectomy you must also agree to use a second form of birth control. If your partner becomes pregnant during the study or within 3 months after you took your last dose of study treatment, you must tell the study doctor right away. Your study doctor and the sponsor will ask your partner to allow them to collect information about her pregnancy and the health of the baby in a separate consent form. If you or your partner becomes pregnant while participating in this study, you MUST contact your study doctor immediately.

Although you will undergo some tests involving ionizing radiation in this protocol, they are the same you would undergo if you were not in this study, and at the same frequency. Therefore, this study does not involve any additional radiation risk for you.
Clinical trial: NCT03670030
Section: Procedures
Subsections: Procedure|Screening (≤ 28 Days Prior To The First Dose Of Study Drug)|Day 1 Of Every Cycle (Unless Otherwise Stated)|Day 8 Of Every Cycle (Unless Otherwise Stated)|Day 15 Of Cycle 1 And Cycle 2 (These May Be Performed As Needed On Day 15 Of Other Cycles After Cycle 1 And Cycle 2)|End Of Treatment Visit|Response Assessment

Before you can receive study drug, the doctor will perform tests to find out whether you can participate in the study. In this study, you will receive ABI-009 given through a vein (intravenous) once weekly for 2 weeks (on days 1 and 8) followed by a week of rest in a 21-day cycle. If you are found to be eligible by your study doctor, you will receive therapy within 28 days. You will be given this study drug until your disease progresses or depending on how well you tolerate the therapy. After you are finished receiving the study drug, you will be followed by phone calls every 3 months, or more frequently if needed, to see how you are doing, and to collect information on any new anti-cancer treatment you may be taking. Your study doctor or staff will tell you when and where you will go for treatment, tests, exams, and procedures. The study doctor or his/her staff will perform the following procedures during the study:

Approved Demographics (date of birth, sex, race, and ethnicity)
Medical/cancer history, record medications you are taking, and record procedures you have had Physical examination, performance status assessment Vital signs (e.g., blood pressure, pulse, respiration rate, temperature, height, weight)
Blood Tests: chemistry, complete blood count (CBC), differential, platelet count, pregnancy test for women of childbearing potential, fasting lipids and cholesterol CT scans (or MRI, if CT is not possible) Adverse events

Approved Physical examination Vital signs (e.g., blood pressure, pulse, respiration rate, temperature, weight)
Record medications you are taking and procedures you have had Blood samples including complete blood count (CBC), differential, and clinical chemistry panel Blood sample for fasting lipids and cholesterol *(every even cycle)*
Blood sample for sirolimus levels which show the amount of study drug in your body *(cycle 2 only)*
ECOG performance status - an assessment your doctor makes about your disease to help them treat your cancer Adverse events assessment

Physical evaluation  
Blood samples including complete blood count (CBC), differential, and clinical chemistry panel Blood sample for sirolimus levels which show the amount of study drug in your body *(cycle 1 and cycle 2 only)*
Adverse event assessment

Physical evaluation  
Vital signs (e.g., blood pressure, pulse, respiration rate, temperature, weight)
Record medications you are taking and procedures you have had Blood samples including complete blood count (CBC), differential, and clinical chemistry panel Blood sample for sirolimus levels which show the amount of study drug in your body *(cycle 1 and cycle 2 only)*
Adverse event assessment

The EOT Visit is a safety follow-up visit that is to be performed within 1 month after the last dose of ABI-009.  
Physical evaluation including performance status assessment Vital signs (e.g., blood pressure, pulse, respiration rate, temperature, weight)  
Vital signs (e.g., blood pressure, pulse, respiration rate, temperature, weight) Record medications you are taking and procedures you have had Record medications you are taking and procedures you have had Urine pregnancy test for women of childbearing potential Blood samples including complete blood count (CBC), differential, and clinical chemistry panel

Tumor response will be assessed by CT (or MRI, if CT is not possible) scan of the chest, abdomen, and pelvis. CT or MRI scans to be performed at the following frequency:
screening followed by every 9 weeks after the first dose of study drug for the first year; then every 12 weeks until disease progression or unacceptable toxicity. End of Treatment Visit CT (or MRI) should be performed only for those subjects that discontinue treatment for a reason other than disease progression.  
An unscheduled scan for suspected disease progression may be performed at any time.
Clinical trial: NCT03670030
Section: Purpose of Research
Subsections: Purpose

You are being asked to take part in this study because you have been diagnosed with an advanced, malignant neuroendocrine tumor of the lung, gastrointestinal tract and/or pancreas that cannot be removed by surgery. The purpose of this study is to determine whether ABI-009 (study drug) will make your cancer smaller and slow the spread of your cancer. ABI-009, human albumin-bound sirolimus, is an experimental drug. "Experimental" means that the drug has not been approved by the Food and Drug Administration (FDA). Sirolimus, the active part of the drug, prevents a biological pathway that is out of control in neuroendocrine cancer cells. Sirolimus and similar types of drugs have been used in many other tumors, including advanced renal cell carcinoma. The human albumin component of ABI-009 may allow sirolimus to reach cancer cells more effectively. ABI-009 has not been approved for the treatment of advanced, malignant neuroendocrine tumors of the lung, gastrointestinal tract and/or pancreas. There are no drugs currently approved for this. The information from this study might help us identify if ABI-009 is safe and effective in this disease.
Clinical trial: NCT03670030
Section: Voluntary Participation
Subsections: Voluntary Participation

Participation in this study is voluntary. You may decide not to participate in this study or you may withdraw from this study at any time without penalty or loss of benefits to which you are otherwise entitled at this site. If you leave the study before the final regularly scheduled visit, you may be asked by the study doctor to make a final visit for some end of study procedures. Your participation in this study will be entered in your electronic medical record here at Ochsner. You should tell your study doctor about all of your past and present health conditions and allergies of which you are aware, and all drugs and medications which you are presently using.
Clinical trial: NCT03670030
Section: Withdrawal from Study
Subsections: Study Withdrawal

Your participation in this study may be stopped at any time by the study doctor or the sponsor without your consent because:  
You do not meet study criteria the study doctor thinks it necessary for your health or safety; you have not followed study instructions; the sponsor has stopped the study; or administrative reasons require your withdrawal.