Clinical trial: NCT03899467
Section: Alternatives
Subsections: Alternative Treatment

If you decide not to enter this study, there are other treatment choices available to you. Please ask your study doctor to discuss these alternatives with you. You do not need to be in this study to receive treatment for your condition.
Clinical trial: NCT03899467
Section: Confidentiality
Subsections: Authorization To Use And Disclose Information For Research Purposes|Who May Use And Give Out Information About You? The Study Doctor And The Study Staff|Information May Be Given To:|Confidentiality|Authorization To Use And Disclose Personal Health Information

What information may be used and given to others? The study doctor will get your demographic and medical information. For example: 6 **of** 12  
- **Past and present medical records** - **Research records** - **Records about phone calls made as part of this research** - **Records about your study visits**
Study records and source documents must be preserved for at least 15 years after the completion or discontinuation of/withdrawal from the study or 2 years after the last approval of a marketing application in an ICH region, whichever is the longer time period.

Who might get this information? The sponsor of this research will get unidentified medical information under HIPAA. "Sponsor" means any persons or companies that are:
- **working for or with the sponsor, or employee (such as study team) of the sponsor.**

- **The US FDA,** - **Department of Health and Human Services (DHHS) agencies,** - **Governmental agencies to whom certain diseases (reportable diseases) must be reported, and** - **Institutional Review Board.**
Why will this information be used and/or given to others?  
- **to do the research,** - **to study the results, and** - **to see if the research was done right.**
If the results of this study are used or made public, **information that identifies you will not be used**. What if I decide not to give permission to use and give out my health information? Then you will not be able to be in this research study. May I review or copy my information? Yes, but only after the research is over. May I withdraw or revoke (cancel) my permission? Yes, but this permission will not stop automatically. You may withdraw or take away your permission to use and disclose your health information at any time. You do this by sending written notice to the study doctor. If you withdraw your permission, you will not be able to stay in this study or join the study again at a later time. When you withdraw your permission, no new health information will be gathered after that date. Information that has already been gathered may still be used and given to others.

Information from this study will be given to the sponsor. "Sponsor" includes any persons or companies that are contracted by the sponsor to have access to the research information during and after the study.  
7 **of** 12 The information will also be given to the US FDA. Medical records which identify you and the consent form signed by you will be looked at and/or copied for research or regulatory purposes by:  
- **Suzhou Kintor Pharmaceutical, Inc., the sponsor,** - **Syneos Health an agent for the sponsor,**
and may be looked at and/or copied for research or regulatory purposes by:  
- **the FDA,** - **DHHS agencies,** - **governmental agencies in other countries, and** - **Institutional Review Board.**
Absolute confidentiality cannot be guaranteed because of the need to give information to these parties. The results of this research study may be presented at meetings or in publications. Your identity will not be disclosed in those presentations.

The United States government has issued a Privacy Rule to protect the privacy rights of patients. This rule was issued under a law called the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The Privacy Rule is designed to protect the confidentiality of your personal health information. The document you are reading, called an "Authorization," describes your rights and explains how your health information will be used and disclosed (shared). Under federal privacy regulations, you have the right to determine who has access to your personal health information (called "protected health information" or "PHI"). PHI collected in this study may include your medical history, the results of physical exams, laboratory tests, x-ray exams, and other diagnostic and treatment procedures as described in the "Procedures" section of this consent form as well as basic demographic (age, gender, ethnicity) information.  
By signing this form, you allow the study doctor and/or study staff to disclose your information to the sponsor, Suzhou Kintor Pharmaceutical, Inc., and the sponsor's representative(s). The data sent by the study doctor and/or study staff to the sponsor do not include your name, address, or social security number. Your information may be reviewed and/or copied by the sponsor or sponsor's representative(s), FDA, IRB, or by other regulatory agencies in this country or in other countries to ensure the quality of the study or for other uses allowed by law. Federal and state laws require the study doctor and/or study staff to protect the privacy of your information. However, absolute confidentiality cannot be guaranteed because of the need to disclose information as described above. After the study doctor and/or study staff shares your information with the sponsor or others, the law may no longer protect the privacy of the information, and it may be further disclosed.  
You have the right to see and copy your records related to the study for as long as the study doctor has this information in his or her possession. However, by signing this form you agree that you might not be able to review some of your records related to the study until after the study has been completed, at which time your right of access will be restored. This Authorization does not have an expiration date. If you do not revoke (cancel) this Authorization, then it will remain in effect indefinitely. You can revoke (cancel) this Authorization at any time by giving written notice to the study doctor at the address listed on page 1. If you revoke this Authorization, then you will no longer be able to participate in the study, and no new information will be collected for study purposes unless the information concerns an adverse event (a bad effect) related to the study. If an adverse event occurs, your entire medical record may be reviewed. All the information that has been collected prior to revoking the Authorization and any new information about a side effect related to the study may still be used and disclose to the above-mentioned parties. If you withdraw from the study but do not withdraw your Authorization, new personal health information may be collected until this study ends. If you do not sign this Authorization, you cannot participate in this research study or receive study-related treatment. If you withdraw this Authorization in the future, you will no longer be able to participate in this study. Your decision to withdraw your Authorization or not to participate will not involve any penalty or loss of access to treatment or other benefits to which you are entitled.
Clinical trial: NCT03899467
Section: Participant Responsibilities
Subsections: Patient Responsibilities During The Study, You Will Have The Following Responsibilities:

**Report to your study doctor or study nurse immediately if you feel allergic to the study drug,**
fatigue/lethargy, dizziness, pain or edema in hands and feet, loss of appetite, and symptoms that have significant impact on your daily activities. If the study drug dose is deemed too high for you, your doctor may ask you to take a couple of days off or/and reduce the dose of study drug.  
**Attend all scheduled visits.**
**Take the study drug as directed.** **Return any unused study drug and containers as instructed by the study staff.** **Follow the study doctor's instructions about whether you may continue to take your regular**
prescribed medications or over-the-counter medicines during the study period.  
**Tell the study doctor all drugs you are taking, any changes to your current medications, illnesses or**
injuries, unexpected or troublesome side effects, or problems that are not mentioned above.  
**Tell the study doctor if you plan to have an elective surgery or any other medical treatment or**
procedure.  
**You should continue to make regular visits to your primary doctor or any other special doctors**
whom you were seeing before starting the study, since being in the study does not replace regular medical care.  
**Make sure that the study drug is kept out of the reach of children and people who have a limited**
capacity to read or understand. You are the only person who should take the study drug. Contact the study doctor if you find you have any questions about the study after you sign this form.  
**You and/or your partner must use a reliable form of contraception during the study and for at least**
3 months after you are off from the study drug. If your partner becomes pregnant while you are in the study, be sure to tell the study doctor as soon as possible.
Clinical trial: NCT03899467
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Safety Follow-Up|Study Procedure Risks|Potential Risks And Discomforts Associated With Gt0918|Other Risks

You will visit the clinic or be called 30 days after your last dose to check any experimental drug-related side effect you may have.  
Unscheduled Visits Your study doctor may at his/her discretion arrange for you to have an unscheduled visit, especially in the case of disease conditions or/and side effects that require follow-up or considered by study doctor.

Blood Tests For many subjects, needle punctures for blood draws do not cause any serious problems. Some side effects that may be seen are bleeding, bruising, discomfort, infections, dizziness, and/or pain at the needle site.  
Imaging Tests Some imaging techniques that may be used to follow your cancer include CT, MRI, positron emission tomography, and x-rays. These tests will expose you to a moderate to high doses of ionizing radiation. Some people may also get claustrophobic (feel closed in) from being in the imaging machine, which is sometimes in the shape of a tube.

This is an Expanded /Phase 2 study is to find best dosing with less side effects in more number of study subjects. Thus, there may be side effects that are not known at this time. From limited subjects in clinical study that occurred with this study drug and common in patients with cancer, you may expect or experience any of the following adverse events (side effects) during your treatment, possibly, fatigue, lethargy, headache, nausea, vomiting, dizziness, loss of appetite, weight loss, diarrhea, hot flushes, hypercholesterolemia, hyperglycemia, hypertriglyceridemia, peripheral edema, constipation, back pain, anemia, pain in extremities, arthralgia, elevated creatine kinase, transaminase elevation, liver injury, hepatic failure, hepatic cirrhosis. Should any of these side effects occur, you should immediately notify your doctor or/and study staff.  
  
  
As a study subject, you should not get your sexual partner pregnant while taking the study drug. The effects of the study drug on sperm, embryos, or fetuses are not known. If you think that your partner may have gotten pregnant during the study, you must tell your study doctor immediately.

The study drug is a CYP 3A4 inhibitor and has shown some level of drug interactions with CYP 3A4 components in some patients during this trial. For example, several patients on simvastatin 40 mg or higher daily resulted in elevated lab results of ALT, AST, CK, muscle pain, rhabdomyolysis (damage to skeletal muscle), etc. Please discuss with your doctor the list of potential interactions Your condition may not get better or may get worse during this study. Only you should take the study drug. It must be kept out of the reach of children or anyone else who may not be able to read or understand the label.
Clinical trial: NCT03899467
Section: Procedures
Subsections: Procedures

The doctor in charge of this study or a member of the study staff will have discussions with you regarding the requirements for participation in this study. In order to participate in this expanded/phase II study, one of the selection criteria is prior therapy of abiraterone or enzalutamide, not both. As a subject in this study, you will receive active study drug. You should take the study drug by mouth on an empty stomach (or 2-3 hours after a meal).
Clinical trial: NCT03899467
Section: Purpose of Research
Subsections: Purpose Of The Study

You are being asked to take part in this research study as your prostate cancer has not responded to or progressed on hormonal therapy abiraterone or enzalutamide.  
Prostate cancer requires testosterone to grow and spread. Goal of the treatment of prostate cancer is to remove the source of male hormones, either surgically (castration) or by giving drugs to both stop the production of male hormones and to block the effect of male hormones on the prostate cancer.  
The current approved drugs, XTANDI® (enzalutamide), or Zytiga® **(abiraterone) can block the male**
hormone activity; however, the medication does not work for everyone or for all time. Now if your disease gets worse or you have serious side effects from either of these drugs, you may be qualified for this study. There are 2 parts (stages) to this research study and first part of study has finished. This is the second part of the expanded/Phase 2 study. It is to learn if the drug is safe in more patients who are administered the drug and to find the best dose to take with the least side effects. There are 60 patients who will participate in this study and will be randomized (like the flip of a coin) to orally receive study drug at 400 mg, or 500 mg daily. If you are enrolled into the current study, you will be asked to take GT0918 tablets every day by mouth on an empty stomach (or 2-3 hours after a meal) for up to 6 months, have blood drawn, and safety tests performed at multiple times through-out your participation in this study. All participants will be evaluated by the study doctor and the doctor's staff for side effects. While taking the study drug, if your study doctor sees that you are receiving clinical benefits, you may continue on the study after you finish the first 6 months of study drug.
Clinical trial: NCT03899467
Section: Voluntary Participation
Subsections: Voluntary Participation And Withdrawal

Your participation in this study is voluntary. You may decide not to participate, or you may leave the study at any time. Your decision will not result in any penalty or loss of benefits to which you are otherwise entitled. Your participation in this study may be stopped at any time by the study doctor or the sponsor without your consent for any reason, including:  
- **discovery that you do not meet the study requirements** - **if it is in your best interest**
- **if you do not consent to continue in the study after being told of changes in the research that may**
affect you
- **any change in your medical condition that might make continuation in the study harmful to you** - **your failure to follow the study doctor's instructions** - **Cancellation of the study**
If you leave the study before the planned final visit, you may be asked by the study doctor to have some tests or procedures done so that you leave the study safely.
Clinical trial: NCT03899467
Section: Withdrawal from Study
Subsections: End Of Study Or Early Termination

You will visit the clinic after your last dose of study drug, and the study doctor and staff will ask you questions about medications you are taking, how you are doing, and any side effects you may experience since the previous visit. You will also have vital signs taken, a brief physical examination performed, and 4 **of** 12 your physical capability (ECOG) assessed. The study staff will count your pills if not already completed to ensure that you comply with the protocol. You will have blood drawn (about 2 to 3 tablespoons) for hormone and exploratory marker testing. You will be discharged from the clinic after all procedures are completed. If you are unable to attend the End of Study visit in person, a phone call will be made to ask you questions about medications you are taking and any side effects since the previous visit. You may also be asked questions to assess your physical capability (ECOG).