Clinical trial: NCT03180528
Section: Alternatives
Subsections: Alternatives

You do not have to be in this study to receive treatment for your cancer. Instead of taking part in this study, you may choose to receive treatment with other cancer drugs or have immediate surgical treatment. Your study doctor will discuss the risks and benefits of other treatments with you. The Study Doctors will discuss with you the risks and benefits of these alternatives, including which other treatments might be suitable for you. If you decide that you do not wish to take part in this study and wish to pursue any of these, or other alternatives, this will not change your regular medical care or the other treatment choices in any way.
Clinical trial: NCT03180528
Section: Confidentiality
Subsections: Confidentiality|Certificate Of 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?|When Will My Authorization Expire?|Will Access To My Medical Record Be Limited During The Study?

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. Patient information may be provided to Federal and other regulatory agencies as required. The US 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 Remetinostat; the results will be provided to the sponsor, the Food and Drug Administration and other federal and regulatory agencies as required.

This research is covered by a Certificate of Confidentiality from the National Institutes of Health. The researchers with this Certificate may not disclose or use information, documents, or biospecimens that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a court subpoena, unless you have consented for this use. Information, documents, or biospecimens protected by this Certificate cannot be disclosed to anyone else who is not connected with the research except, if there is a federal, state, or local law that requires disclosure (such as to report child abuse or communicable diseases but not for federal, state, or local civil, criminal, administrative, legislative, or other proceedings, see below); if you have consented to the disclosure, including for your medical treatment; or if it is used for other scientific research, as allowed by federal regulations protecting research subjects.  
  
IRB Use Only  
  
Approval Date: April 15, 2020 Expiration Date: April 15, 2021  
| Protocol Director:   | Kavita Sarin, MD, PhD      |
|----------------------|----------------------------|
| Protocol Title:      | Basal Cell Carcinoma (BCC) |  
Protocol Title:  
A Phase 2 Open label, Single arm Trial to Investigate the Efficacy and Safety of Topical  
Remetinostat Gel as Neoadjuvant Therapy in Patients Undergoing Surgical Resection of  
Basal Cell Carcinoma (BCC)

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 information related to your medical condition, blood tests, pathology, EKG, physical exam, current medications, side effects, and photos of lesions and medical imaging results. The researchers will also get information from your medical record (including hospital records from the Stanford Healthcare and your referring physician's records).

The following parties are authorized to use and/or disclose your health information in connection with this research study:
- The Study Doctor, Kavita Sarin, MD, PhD
- Research Staff - The Stanford University Administrative Panel on Human Subjects in Medical Research; the Stanford Data and Safety Monitoring Committee (DSMC); and/or 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:
- Medivir AB or their representatives
- The American Skin Association
- The Food and Drug Administration (FDA) and/or other state or international regulatory authorities  
  
  
Approval Date: April 15, 2020 Expiration Date: April 15, 2021  
| Expiration Date: April 15, 2021   |                                                                                                                  |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------|
| Protocol Director:                | Kavita Sarin, MD, PhD  A Phase 2 Open label, Single arm Trial to Investigate the Efficacy and Safety of Topical  |
| Protocol Title:                   | Remetinostat Gel as Neoadjuvant Therapy in Patients Undergoing Surgical Resection of  Basal Cell Carcinoma (BCC) |  
- The Office for Human Research Protections (OHRP) in the US Department of Health and Human Services (DHHS)
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.

Your authorization for the use and/or disclosure of your health information will end on 31 December 2032 or when the research project ends, whichever is earlier.

To maintain the integrity of this research study, you may not have access to any health information developed as part of this study until it is completed. At that point, you would have access to such health information if it was used to make a medical or billing decision about you (eg, if included in your official medical record). ___________________________________________ ____________
Signature of Adult Participant Date
___________________________________________ Printed Name of Adult Participant NOTE: If using the Short Form *Consent process for informed consent in another* language pursuant to an "Alteration of HIPAA Authorization," the participant should not sign the HIPAA "Authorization To Use Your Health Information For Research Purposes" above.  
  
  
IRB Use Only  
Approval Date: April 15, 2020  
Expiration Date: April 15, 2021  
| Expiration Date: April 15, 2021   |                                                                                                                  |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------|
| Protocol Director:                | Kavita Sarin, MD, PhD  A Phase 2 Open label, Single arm Trial to Investigate the Efficacy and Safety of Topical  |
| Protocol Title:                   | Remetinostat Gel as Neoadjuvant Therapy in Patients Undergoing Surgical Resection of  Basal Cell Carcinoma (BCC) |
Clinical trial: NCT03180528
Section: Duration of Study Involvement
Subsections: Duration Of Study Involvement

It is planned that each participant will take part in this study for about 8 weeks. This is a 2-year study with 6 weeks of active treatment where we will collect medical information for each participant.
Clinical trial: NCT03180528
Section: Participant Responsibilities
Subsections: Participant Responsibilities

As a participant, your responsibilities include:  
- Follow the instructions of the Study Doctor and study staff.  
- Apply the study drug as instructed. Apply your last dose 30 mins before your BCC(s) is surgically removed.  
- Keep your study appointments. If it is necessary to miss an appointment, please contact the Study Doctor or research study staff to reschedule as soon as you know you will miss the appointment.  
- Tell the Study Doctor or research study staff about any side effects, doctor visits, or hospitalizations that you may have.  
- Tell the Study Doctor or research staff if you believe you might be pregnant or if your partner becomes pregnant.  
- Keep the study drug refrigerated and in a safe place, away from children and for your use only.  
- Ask questions as you think of them.  
- Tell the Study Doctor or research staff if you change your mind about staying in the study.
Women of Childbearing Potential: If you are a woman who is able to become pregnant, it is expected that you will use an effective method of birth control to prevent exposing a fetus to a potentially dangerous agent with unknown risk. If you are pregnant or currently breast feeding, you may not participate in this study. You understand that if you are pregnant, if you become pregnant, or if you are breast-feeding during this study, you or your child may be exposed to an unknown risk. In order to confirm that you are not pregnant (to the extent medically possible), you agree to choose to have a pregnancy test done before beginning this research study. You must agree to avoid sexual intercourse or use a birth control method judged to be effective by the Study Doctor and which will not interfere with the proposed investigation. You must accept the risk that pregnancy could still result despite the responsible use of reliable method of birth control. You agree to notify the Study Doctor as soon as possible of any failure of proper use of your birth control method, or if you become pregnant, either of which may result in your being withdrawn from the study. If you are a man participating in this study and your partner is able to become pregnant, you and your partner must use adequate contraception while you are participating in the study and for 3 months after stopping treatment. Your doctor will discuss with you what methods of birth control are considered adequate. You should inform your study doctor if your partner becomes pregnant during the study or within 3 months of stopping treatment.  
  
  
| Expiration Date: April 15, 2021   |                                                                                                                  |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------|
| Protocol Director:                | Kavita Sarin, MD, PhD  A Phase 2 Open label, Single arm Trial to Investigate the Efficacy and Safety of Topical  |
| Protocol Title:                   | Remetinostat Gel as Neoadjuvant Therapy in Patients Undergoing Surgical Resection of  Basal Cell Carcinoma (BCC) |  
Your doctor will discuss with you whether your preference for birth control is considered adequate.
Clinical trial: NCT03180528
Section: Participant's Rights
Subsections: Participant'S Rights|Do I Have To Sign This Authorization Form?|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 Study Doctor. You will still receive care for your disease and will not lose any benefits to which you would otherwise be entitled. You will be told of any significant 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. After you hear about this information, you have the right to withdraw from the program.

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.

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;
- Be instructed that consent to participate in the medical experiment may be withdrawn at any time and the subject may discontinue participation without prejudice;  
  
  
  
  
Approval Date: April 15, 2020 Expiration Date: April 15, 2021  
MD, PhD  
Protocol Title:
A Phase 2 Open label, Single arm Trial to Investigate the Efficacy and Safety of Topical Remetinostat Gel as Neoadjuvant Therapy in Patients Undergoing Surgical Resection of Basal Cell Carcinoma (BCC)
- 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.
Signing your name means you agree to be in this study and that you will receive a copy of this signed and dated consent form.  
_______________________________________________ Printed Name of Adult Participant  
_______________________________________________ ____________ Signature of Adult Participant Date _______________________________________________ _____________ Signature of Person Obtaining Consent (POC) Date
Clinical trial: NCT03180528
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Possible Risks, Discomforts, And Inconveniences|Risks From Remetinostat (Shp-141)|Risks From Topical Treatments|Allergic Reactions|Risks Of Giving Blood (Venipuncture)|Risks For Women Of Childbearing Potential

There are risks, discomforts, and inconveniences associated with any research study. These deserve careful thought. You should talk with the Study Doctor if you have any questions.

The main remetinostat treatment-related AEs were skin findings including irritation, dermatitis, erythema, dry skin, rash, exfoliation, skin lesion, inflammation, pain, paraesthesia, erythema, pruritus, infection, application site reaction, skin papilloma which resolved on reducing the frequency of remetinostat application or stopping application for short periods of up to 2 weeks. The effect of Remetinostat in pregnancy has not been studied. Similarly, excretion of Remetinostat into breast milk has not been examined. Therefore, pregnant and lactating women are excluded from clinical trials at this time.

Many drugs that are administered topically can cause irritation and/or inflammation of the skin. This may be due to the ingredients the drug is mixed in, or the drug itself.

Sometimes people have allergic reactions to drugs. Although unlikely, especially for an application to a small area of skin, if you have a very bad allergic reaction, you could die. Some things that happen during an allergic reaction that could be a sign or symptom of a life-threatening allergic reaction (anaphylaxis) are:
- Rash  
- Having a hard time breathing (shortness of breath) - Wheezing when you breathe
- Sudden drop in blood pressure
- Swelling around the mouth, throat, or eyes
- Fast pulse
- Sweating
You should get medical help and notify the Study Doctor or study staff if you experience any of these or any other side effects during the study.  
  
IRB Use Only  
Approval Date: April 15, 2020  
Expiration Date: April 15, 2021  
| Expiration Date: April 15, 2021   |                                                                                                                  |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------|
| Protocol Director:                | Kavita Sarin, MD, PhD  A Phase 2 Open label, Single arm Trial to Investigate the Efficacy and Safety of Topical  |
| Protocol Title:                   | Remetinostat Gel as Neoadjuvant Therapy in Patients Undergoing Surgical Resection of  Basal Cell Carcinoma (BCC) |

The Study Doctor or study staff will take your blood by sticking a needle in your arm. Some problems you might have from this are pain, bruising, dizziness and infection.

If you are a woman, you cannot be in this study if you are pregnant. Woman should not breastfeed a baby while in this study. You must not become pregnant during the study or within 3 months of stopping treatment.  
If you are pregnant or nursing while receiving Remetinostat, there may be risks to the fetus or nursing child. Nobody knows what these risks are right now. Some drugs cause premature (early) birth or birth defects. All historically documented and confirmed post-menopausal women (women who no longer have menstrual periods), surgically sterile women, or women using a medically acceptable form of birth control will be considered for participation in the study. All women who can have children will have a serum pregnancy test as part of the screening visit. If you have a positive pregnancy test, you will not be able to enter in the study. The only certain way to prevent pregnancy is to not have sex. If you are a woman who can have children, the study staff will talk to you about birth control you must use during the study. Even if you use a medically proven birth control method, there is a chance you could still become pregnant. Some types of birth control will not work when you are taking certain drugs. If you think you are pregnant during the study or become pregnant within 3 months of stopping treatment, you must tell the Study Doctor immediately. Women who become pregnant during the study will have to leave the study. If you become pregnant, you will be removed from the study. The study doctor or study staff may ask for information about the pregnancy and the birth of the baby. The study doctor will share this information with the sponsor and the IRB (a group of people who review research studies to protect the rights and welfare of research participants).  
  
| Expiration Date: April 15, 2021   |                                                                                                                  |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------|
| Protocol Director:                | Kavita Sarin, MD, PhD  A Phase 2 Open label, Single arm Trial to Investigate the Efficacy and Safety of Topical  |
| Protocol Title:                   | Remetinostat Gel as Neoadjuvant Therapy in Patients Undergoing Surgical Resection of  Basal Cell Carcinoma (BCC) |
Clinical trial: NCT03180528
Section: Procedures
Subsections: Procedures

It may be harmful to enter this study while receiving some medications; therefore, you will be excluded if you are taking certain medications. Your Study Doctor will review your medications and let you know. Research studies are usually dividing into at least 3 parts, typically consisting of:  
1. Testing to see if you are eligible to participate in the study ("Screening"); 2. Testing during study treatment to monitor your health and the effects of the study treatment ("Study Evaluation Procedures"); and  
  
| Expiration Date: April 15, 2021   |                                                                                                                  |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------|
| Protocol Director:                | Kavita Sarin, MD, PhD  A Phase 2 Open label, Single arm Trial to Investigate the Efficacy and Safety of Topical  |
| Protocol Title:                   | Remetinostat Gel as Neoadjuvant Therapy in Patients Undergoing Surgical Resection of  Basal Cell Carcinoma (BCC) |  
3. Testing after your treatment is complete ("Follow-up"). Testing/procedures for each of these parts are described separately below.  
Some of these examinations, tests, or procedures may be part of your regular medical care, and/or and may be done even if you do not join the study. If you have had some of them recently, they may not need to be repeated. Before you join this study, Kavita Sarin, MD, PhD, and her research study team will review this document with you and ask you to sign this informed consent document. After you have signed this document, and received a signed copy, the study will begin with a Screening Visit. All the procedures listed below are research-related and not part of your regular medical care, with the exception of the planned removal of your BCC at week 8 of the study.
Clinical trial: NCT03180528
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?

The study team hopes to learn if there is any beneficial effect of Remetinostat at the doses to be used in this study, and if Remetinostat is safe to use at those doses.  
"Phase 2" means the study will include assessments of how well the Remetinostat works in treating your cancer. The study team hopes to learn if 6 weeks of topical Remetinostat applied 3 times a day will slow the growth of BCCs. We also hope to learn if topical Remetinostat will affect a biomarker called "Gli" that is known to be involved in BCC development. A "biomarker" is a biological marker that we can measure to assess a medical condition or disease such as BCC. It is hoped that Remetinostat could be used in the future to treat or prevent BCCs. Your regular medical care for a BCC would include surgical removal of the site of the cancer. The current standard anti-BCC treatment for your lesion includes drugs like Efudex (also known as Fluorouracil) and Aldara (also known as Imiquimod). Using these therapies, some patients with BCCs receive treatment benefit, but are not cured of their disease. Your regular medical care would also include skin checks every 3 to 6 months;  
  
  
  
| Expiration Date: April 15, 2021   |                                                                                                                  |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------|
| Protocol Director:                | Kavita Sarin, MD, PhD  A Phase 2 Open label, Single arm Trial to Investigate the Efficacy and Safety of Topical  |
| Protocol Title:                   | Remetinostat Gel as Neoadjuvant Therapy in Patients Undergoing Surgical Resection of  Basal Cell Carcinoma (BCC) |  
biopsies of lesions; and surgical removal of additional BCC lesions as they are identified. We are requesting that you delay removal of your BCC lesion by up to 12 weeks while you participate in our study. BCCs are typically slow-growing cancers. Delaying removal by up to 12 weeks should not have a significant effect on your BCC. Regular medical care for BCC would be to schedule the surgery within a week or several weeks. The use of Remetinostat in this research study is investigational ("experimental"). The word "investigational" means that Remetinostat is not approved by the US Food and Drug Administration (FDA) for use in the United States to treat BCCs. This study is being conducted under an application submitted to FDA, called an "Investigational New Drug Application" or "IND." Remetinostat will be provided by the drug manufacturer, Medivir AB. If you decide to terminate your participation in this study, you should notify Dr. Kavita Sarin at xxx-xxx-xxxx This research study is looking for up to 30 people with early stage BCC, of which at least 10 people are planned to participate in the optional biopsy study. Stanford University expects to enroll research study participants until data on 30 tumors has been collected.

The primary purpose of this study is to determine if 6 weeks of topical Remetinostat applied three times daily will suppress Basal Cell Carcinoma. If you choose to participate, the study staff will obtain personal information about you for research purposes. This may include medical and research records that may identify you and that may describe your health. The Study Doctor and research staff may obtain and give out records about your study visits, physical exams, medical history, telephone calls, laboratory results, other test results and response to study treatment including side effects, medications, and study drug you received.
Clinical trial: NCT03180528
Section: Voluntary Participation
Subsections: Voluntary Participation

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.
Clinical trial: NCT03180528
Section: Withdrawal from Study
Subsections: Withdrawal From The Study|If I Sign, Can I Revoke It Or Withdraw From The Research Later?

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 Dr. Kavita Sarin at xxx-xxx-xxxx . If you withdraw after starting treatment with the study drugs, your Study Doctor will need to check on your health status afterwards. If you do not want the Study Doctor to check on your health status after withdrawing from the study, you should say so. Any information collected before you withdraw will be kept and used to complete the research. To help you safely finish your participation in the study, the Study Doctors may ask you to have more tests and you will be asked to come into the clinic for an End-of-Treatment Visit. The Study Doctor will discuss your treatment options with you at this time. If your participation in the study is ended, you must return all study-related supplies, including unused Study Drug. The Study Doctor 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:  
- Your cancer gets worse.  
- Failure to follow the instructions of the Study Doctor and/or study staff. - The Study Doctor decides that continuing your participation could be harmful to you.  
- Pregnancy - You need treatment not allowed in the study. - The study is cancelled. - Other administrative reasons.  
- Unanticipated circumstances.
After you finish the study or stop taking the Study Drug for any other reason, you may continue to be checked regularly (physical exams; blood tests; tumor measurements; X-rays; other scans, etc.) if you continue to have significant side effects from the treatment. This is called follow-up. Your Study Doctor will follow your progress, in accordance with good medical care, for as long as it is felt to be necessary by both you and the Study Doctor, unless you ask otherwise. Many if not all of these procedures will  
  
IRB Use Only  
Approval Date: April 15, 2020  
Expiration Date: April 15, 2021  
| Expiration Date: April 15, 2021   |                                                                                                                  |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------|
| Protocol Director:                | Kavita Sarin, MD, PhD  A Phase 2 Open label, Single arm Trial to Investigate the Efficacy and Safety of Topical  |
| Protocol Title:                   | Remetinostat Gel as Neoadjuvant Therapy in Patients Undergoing Surgical Resection of  Basal Cell Carcinoma (BCC) |  
be part of your regular continued medical care. In addition, further treatment outside the study will be discussed with you.

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  
  
  
  
  
Approval Date: April 15, 2020 Expiration Date: April 15, 2021  
| Expiration Date: April 15, 2021   |                                                                                                                  |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------|
| Protocol Director:                | Kavita Sarin, MD, PhD  A Phase 2 Open label, Single arm Trial to Investigate the Efficacy and Safety of Topical  |
| Protocol Title:                   | Remetinostat Gel as Neoadjuvant Therapy in Patients Undergoing Surgical Resection of  Basal Cell Carcinoma (BCC) |  
revoke your authorization for the research use or disclosure of your health information in this study, you must write to:
Kavita Sarin, MD, PhD Dermatology - North Campus 450 Broadway St Redwood City, CA 94063