Clinical trial NCT04608409
Conditions: Ovarian Cancer
Keywords: platinum-resistant
Sponsor: Frederick R. Ueland, M.D.
Start date: 2021-03-17; Completion date: 2024-05-17
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This trial will be a phase I dose-escalation study of lapatinib and paclitaxel for platinum-resistant ovarian cancer, which will establish the phase II dose for subsequent efficacy trials.

Detailed description:
While ABCB1 (P-glycoprotein 1) upregulation after paclitaxel administration is well known, there is currently no clinically available method for preventing or overcoming it. To develop a therapy able to prevent ABCB1 upregulation and paclitaxel resistance, several ABCB1 inhibitors have been evaluated in combination with paclitaxel in preclinical model systems. Pulsed-dose lapatinib and paclitaxel are synergistic and inhibition of ABCB1 by lapatinib increases sensitivity to paclitaxel. Lapatinib is FDA approved, orally available, and previously studied in combination with weekly paclitaxel for breast cancer at doses of 1000mg to 1250mg daily (7000-8250mg per week). This trial will use twice-daily dosing of lapatinib at a starting dose of 750 mg for 2 days (1500mg a day and 3000mg weekly dose), which is less than half of the continuous dose and has been shown to achieve plasma concentrations at 48 hours that are associated with synergy. Therefore, these findings can be translated into a novel, well-tolerated, and convenient combination regimen with significant potential for clinical activity. This trial will be a phase I dose-escalation study of lapatinib and paclitaxel for platinum-resistant ovarian cancer, which will establish the phase II dose for subsequent efficacy trials.

Arms: arm 1: Patients in this group will receive Lapatinib (750mg PO BID) and Paclitaxel (80mg/m2). arm 2: Patients in this group will receive Lapatinib (1500mg PO BID) and Paclitaxel (80mg/m2). arm 3: Patients in this group will receive Lapatinib (2000mg PO BID) and Paclitaxel (80mg/m2).
Interventions: intervention 1: Lapatinib and Paclitaxel
Intervention descriptions: intervention 1: Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.

Protocol documents:
Prot_SAP_ICF_000.pdf: 




























































































































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Consent and Authorization to Participate in a Research Study 
 
KEY INFORMATION FOR MCC-20-GYN-06-PMC: A PHASE I DOSE ESCALATION STUDY ON THE 
SAFETY OF LAPATANIB WITH DOSE-DENSE PACLITAXEL IN PATIENTS WITH PLATINUM- 
RESISTANT OVARIAN CANCER 
 
We are asking you to choose whether or not to volunteer for a research study about the good and bad effects of 
using the combination of lapatinib and paclitaxel, at different doses, in the treatment of ovarian cancer that has 
returned after receiving treatment with platinum-based chemotherapy drugs. We are asking you because your 
ovarian cancer has returned after receiving platinum-based chemotherapy. This page is to give you key 
information to help you decide whether to participate. We have included detailed information after this page. Ask 
the research team questions. If you have questions later, the contact information for the research investigator in 
charge of the study is below. 
 
WHAT IS THE STUDY ABOUT AND HOW LONG WILL IT LAST? 
By doing this study, we hope to learn about the good and bad effects of using the combination of lapatinib and 
paclitaxel, at different doses, in the treatment of platinum-resistant ovarian cancer that has returned after 
treatment. 
Lapatinib is FDA approved to be used together with another medication to treat certain types of breast cancer 
that has not responded to the standard treatment. Paclitaxel is FDA approved for the treatment of breast 
cancer, non-small cell lung cancer, and pancreatic cancer. The combination of lapatinib and paclitaxel has not 
been approved for ovarian cancer. However, some studies suggest that Lapatinib may help paclitaxel work 
better. Since twice-daily dosing lapatinib has not been studied in combination with paclitaxel, we are proposing 
this study to learn about whether this combination will improve your health and to learn more about the side 
effects associated with different dosages. 
Your participation in this research will last up to about 1 year and 4 months. That includes about 4 weeks for 
screening and three, 28-day cycles of treatment. In addition, you will be followed for up to one year after 
completing treatment. 
 
WHAT ARE KEY REASONS YOU MIGHT CHOOSE TO VOLUNTEER FOR THIS STUDY? 
Lapatinib may help paclitaxel work better by making tumor cells more sensitive to the drug. Lapatinib may also 
stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving lapatinib 
together with paclitaxel may kill more tumor cells. For a complete description of benefits, refer to the Detailed 
Consent. 
 
WHAT ARE KEY REASONS YOU MIGHT CHOOSE NOT TO VOLUNTEER FOR THIS STUDY? 
We do not know if the combination of lapatinib and paclitaxel will improve your health. The usual approach for 
patients who are not in a study is typically treatment with standard chemotherapy, or other investigational 
chemotherapy or biologic drugs. 
Standard chemotherapy drugs that are already FDA-approved for use in recurrent ovarian, primary peritoneal, 
or fallopian tube cancer include paclitaxel, topotecan, or pegylated liposomal doxorubicin (PLD). Bevacizumab 
in combination with chemotherapy (topotecan, paclitaxel or PLD) is also FDA-approved for women with 
platinum-resistant recurrent cancer listed above who received no more than two prior chemotherapy treatments. 
The study doctor will discuss with you the risks and benefits of the study treatment compared to the standard 
treatment to help you decide whether or not to take part in this study.  
You may not want to participate in this study because of the side effects listed in the detailed consent below. 
For a complete description of risks, refer to the Detailed Consent and/or Appendix. 
 
DO YOU HAVE TO TAKE PART IN THE STUDY? 
If you decide to take part in the study, it should be because you really want to volunteer. You will not lose any 
services, benefits or rights you would normally have if you choose not to volunteer. 
 
 


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WHAT IF YOU HAVE QUESTIONS, SUGGESTIONS OR CONCERNS? 
If you have questions, suggestions, or concerns regarding this study or you want to withdraw from the study 
contact Frederick Ueland, MD of the University of Kentucky, Department of Medicine at (859) 257-1613 or 
via email at fuela0@uky.edu.  If you have any concerns or questions about your rights as a volunteer in this 
research, contact staff in the University of Kentucky (UK) Office of Research Integrity (ORI) between the 
business hours of 8am and 5pm EST, Monday-Friday at 859-257-9428 or toll free at 1-866-400-9428. 
 
DETAILED CONSENT: 
 
ARE THERE REASONS WHY YOU WOULD NOT QUALIFY FOR THIS STUDY? 
You should not participate in this study if you are: 
 
• Under the age of 18; 
• Pregnant, lactating, or intend to get pregnant during the study; 
• Currently taking any other investigational agents; 
• Currently taking other medications or foods (e.g. grapefruit/grapefruit juice) which are not allowed while on this 
study. The study doctor will review your usage of these items and discuss them with you. 
• Unwilling/unable to commit to the amount of time needed to take part in this study
• There are other criteria that must be met to take part in this study that your study doctor will review with you. 
 
WHERE WILL THE STUDY TAKE PLACE AND WHAT IS THE TOTAL AMOUNT OF TIME INVOLVED? 
The research procedures will be conducted at University of Kentucky Medical Center and Markey Cancer Center 
facilities. You will need to come in 14 times during the study. Most visits will take between 1- 2 hours. The visits 
on the days you receive drug via infusion (days 1, 8, 15) during cycles 1-3, will take between 4-6 hours. The total 
amount of time you will be asked to volunteer for this study is about 55 hours. The amount of time will vary 
depending on how you respond to treatment. 
 
WHAT WILL YOU BE ASKED TO DO? 
 
You will be asked if you are interested in taking part in this research study. If you are interested, you will be asked 
to read this informed consent form and ask any questions you may have and decide whether you want to take 
part in the study. If you agree to be in the study, you will be asked to sign and date the last page of this form. 
 
Pre-study Screening (completed within 4 weeks prior to initiation of treatment) 
 
In order to find out if you can take part in the study, the following procedures will be done: 
 
The study doctor will ask you about your medical history, including any medicines, herbal/natural remedies, 
vitamins, or other over-the-counter (e.g., aspirin) items that you have taken in the last 90 days or are taking now. 
 
The study doctor will collect demographic information. 
 
You will have a full physical examination performed by a medical doctor to check your health status. He or she will 
evaluate your performance status (a measure of your general well-being and your abilities to carry out activities of 
daily life) 
 
Your blood pressure, heart rate, the number of times you breathe per minute, your body temperature (known as 
vital signs), and your height and weight will be measured. You will also have an Electrocardiogram (EKG) to 
evaluate your heart’s functioning. 
 
You will be asked to provide a sample of your blood (about 3 tablespoons, or 45 milliliters) via venipuncture and 
urine to check your heart, blood, liver, thyroid, and kidney functions. You will also be asked to provide a blood 
sample to test for the amount of CA 125 (cancer antigen 125) in your blood. 
 
If you are a woman who might be able to get pregnant, you will be required to have a urine test to check for 
pregnancy before you start the study. If you are currently pregnant or have immediate plans to become pregnant, 
you may not take part in this study. Both men and women of childbearing potential who take part in the study 


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must agree to use an effective form of birth control (such as an intrauterine device (women only) and/or condoms) 
during the study, as well as 90 days after the last dose of study treatment. You should discuss birth control 
options for you and your partner with your study doctor prior to starting the study. 
 
You may be asked to undergo some imaging (PET/CT scan, bone scan and/or CT of the chest, abdomen and pelvis) 
as per standard treatment. A computed tomography (CT) scan combines a series of X-ray images taken from 
different angles around your body and uses computer processing to create cross-sectional images (slices) of the 
bones, blood vessels and soft tissues inside your body. A Positron Emission tomography or commonly called PET 
scan is an imaging test that utilizes a specifically designed camera to view the internal organs of the body. It is done 
by injecting a radioactive tracer intravenously through the arm. Tracer is a chemical in liquid form that emits 
positrons that can be identified and modified into a picture of your organs and soft tissue.
All lab tests and radiographic (imaging) studies should be completed within 4 weeks prior to registration/initiation 
of treatment. 
 
During Cycles 1-3, on Days 1, 8, 15
 
The study doctor will ask you about any medicines, herbal/natural remedies, vitamins, or other over-the-counter 
(e.g., aspirin) items that you have taken in the last 90 days or are taking now. 
 
The study doctor will collect demographic information. 
 
You will have a full physical examination performed by a medical doctor to check your health status. He or she will 
evaluate your performance status (a measure of your general well-being and your abilities to carry out activities of 
daily life). 
 
Your blood pressure, heart rate, the number of times you breathe per minute, your body temperature (known as 
vital signs), and your height and weight will be measured. 
 
You will be asked to provide a sample of your blood (about 3 tablespoons, or 45 milliliters) via venipuncture and 
urine to check your heart, blood, liver, thyroid, and kidney functions. You will also be asked to provide a blood 
sample to test for the amount of CA 125 (cancer antigen 125) in your blood. Some of this blood will also be used 
to learn more about how your body handles the study drugs and to test for genetic biomarkers. 
 
You will receive paclitaxel intravenously (in your vein). The study team will monitor you during the infusion for side 
effects. After the infusion, you will be provided lapatinib to be taken later, at home, as per the doctor’s instructions. 
 
During Cycles 1 -3, on Days 6, 7, 13, 14 
 
You will take the lapatinib tablets, by mouth, as per the study doctor’s instructions. 
 
The study doctor will ask you about any medicines, herbal/natural remedies, vitamins, or other over-the-counter 
(e.g., aspirin) items that you have taken in the last 90 days or are taking now. 
 
You will be asked to provide a sample of your blood (about 3 tablespoons, or 45 milliliters) via venipuncture and 
urine to check your heart, blood, liver, thyroid, and kidney functions. 
 
You will be provided with a medication diary. In it, you will be asked to keep track of the study drug you have take 
since the last visit. 
 
Visit 4 weeks after start of treatment +/- 2 weeks 
 
You will also be asked about any side effects you have experienced since your last visit. Depending on the type 
and severity of your side effects, your next treatment may be delayed until they have resolved. In some cases you 
may come off study treatment. 
 
You will have a full physical examination performed by a medical doctor to check your health status. He or she will 


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evaluate your performance status (a measure of your general well-being and your abilities to carry out activities of 
daily life) 
 
The study team will review your medication diary and you will return any unused medication. 
After 3 cycles +/-21 days 
 
Once you are enrolled on-study, you may be asked to undergo imaging (PET/CT scan, bone scan and/or CT of 
the chest, abdomen and pelvis) as per standard treatment, based on clinical indicators such as a rising CA-125 
and/or other clinical symptoms. They will occur approximately every 3 to 6 months and at one year. 
 
Off-Treatment Visit 
You will be asked to complete an off-treatment visit on the last day of your treatment or if you go off treatment 
because your disease progresses (worsens), if you experience side effects of certain types or severities, because 
you decide to no longer take part in the study or for other reasons that your doctor will discuss with you. 
 
During this visit, you will also be asked about any side effects you have experienced since your last visit. You may 
be asked to undergo imaging (PET/CT scan, bone scan and/or CT of the chest, abdomen and pelvis) as per 
standard treatment, based on clinical indicators such as a rising CA-125 and/or other clinical symptoms. 
 
12-Month Post-Treatment Visit/Off-Study 
 
You will be asked to come in for a follow up visit 12 months after completing study treatment. During this visit, you 
will also be asked about any side effects you have experienced since your last visit. You may be asked to 
undergo imaging (PET/CT scan, bone scan and/or CT of the chest, abdomen and pelvis) as per standard 
treatment, based on clinical indicators such as a rising CA-125 and/or other clinical symptoms. 
 
WHAT ARE THE POSSIBLE RISKS AND DISCOMFORTS? 
 
There are risks to taking part in any research study. One risk is that you may get a study drug(s) that do not help 
treat your disease or that makes your condition or disease worse. Another risk is that there may be side effects. 
Everyone taking part in the study will be watched carefully for any side effects. However, researchers do not know 
all the side effects that may happen. 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 soon after you stop receiving the treatment. 
In some cases, side effects can be serious, long lasting, or may never go away. 
 
In a research study, all of the risks or side effects may not be known before you start the study. You should tell 
your doctor or a member of the study team immediately if you experience any side effects. 
Lapatinib Side-Effects 
The following side effects are common (occurring in greater than 30%) for patients taking lapatinib (with other 
commercial agent being administered): 
• 
Diarrhea 
• 
Hand-foot syndrome (Palmar-plantar erythrodysesthesia or PPE) -skin rash, swelling, redness, pain 
and/or peeling of the skin on the palms of hands and soles of feet. Usually mild, has started as early as 2 
weeks after start of treatment. May require reductions in the dose of the medication. 
• 
Low red blood cell count (anemia) 
• 
Nausea and vomiting. 
• 
Elevated liver enzymes (increased AST, ALT, and bilirubin levels). 
 
These are less common side effects for patients receiving lapatinib (with other commercial agent being 
administered): 
• 
Rash 
• 
Low blood counts. Your white blood cells and platelets may temporarily decrease. This can put you at 
increased risk for infection, and/or bleeding. 
• 
Fatigue, tiredness 
• 
Abdominal pain 


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• 
Mouth sores 
•
Heartburn
•
Pain in arms, legs, back
• 
Shortness of breath 
• 
Difficulty sleeping 
 
Dry skin 
 
 
These are rare but serious side effects of lapatinib (with other commercial agent being administered): 
 
 
Heart problems including decreased pumping of blood from the heart, or abnormal heartbeat can occur 
rarely. 
Severe diarrhea, which may lead to dehydration.
 
Paclitaxel Side-Effects 
The following Paclitaxel side effects are common (occurring in greater than 30%) for patients taking Paclitaxel: 
• 
Low blood counts. Your white and red blood cells and platelets may temporarily decrease. This can put 
you at increased risk for infection, anemia and/or bleeding. 
• 
Hair loss 
•
Arthralgias and myalgias, pain in the joints and muscles. Usually temporary occurring 2 to 3 days after 
Paclitaxel, and resolve within a few days. 
• 
Peripheral neuropathy (numbness and tingling of the hands and feet) 
• 
Nausea and vomiting (usually mild) 
• 
Diarrhea 
• 
Mouth sores 
• 
Hypersensitivity reaction - fever, facial flushing, chills, shortness of breath, or hives after Paclitaxel is 
given. The majority of these reactions occur within the first 10 minutes of an infusion. Notify your 
healthcare provider immediately (premedication regimen has significantly decreased the incidence of this 
reaction). 
 
The following are less common side effects (occurring in 10-29%) for patients receiving Paclitaxel: 
 
Swelling of the feet or ankles (edema). 
 
Increases in blood tests measuring liver function. These return to normal once treatment is discontinued 
(see liver problems). 
Low blood pressure (occurring during the first 3 hours of infusion). 
 
Darkening of the skin where previous radiation treatment has been given (radiation recall - see skin 
reactions). 
Nail changes (discoloration of nail beds - rare) (see skin reactions).
 
Side Effects Associated with 
Lapatinib in combination with paclitaxel 
Likely (>20%) 
Less Likely (<=20%) 
Rare but Serious (<3%)
BLOOD AND LYMPHATIC SYSTEM DISORDERS
Anemia (low red blood 
cells)
 
Febrile neutropenia (Fever) 
Neutropenia (Too few neutrophils, a type of 
white blood cells) 
Thrombocytopenia (low level of platelets) 
CARDIAC (HEART) DISORDERS 
 
Left ventricular systolic dysfunction 
ECG abnormality 
(Paclitaxel) 
 
GASTROINTESTINAL (STOMACH AND INTESTINES) DISORDERS
Abdominal distension (swelling)


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Abdominal pain 
Diarrhea
 
Dyspepsia (indigestion)
Flatulence (Gas) 
Mucositis (Pain and inflammation of 
the body's mucous membrane.)
 
Stomatitis (inflammation of the mouth 
and lips) 
 
Nausea
 
 
Vomiting 
 
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS 
Fatigue 
Flu-like symptoms 
 
HEPATOBILIARY LIVER) DISORDERS 
 
Hepatic (liver) failure 
IMMUNE SYSTEM DISORDERS 
 
Allergic reaction 
INVESTIGATIONS 
Alanine aminotransferase increased 
(could indicate liver damage) 
 
Aspartate aminotransferase increased 
(could indicate liver damage) 
 
Blood bilirubin increased (could 
indicate liver damage) 
 
 
Electrocardiogram QT corrected interval 
prolonged (your heart takes longer than 
usual to recover after each beat) 
METABOLISM AND NUTRITION DISORDERS 
Anorexia (low body weight)
 
Dehydration
 
NERVOUS SYSTEM DISORDERS
 
Central Nervous System Toxicity (any) 
Peripheral neuropathy 
(weakness, numbness and 
pain)
 
 
Dysgeusia (distortion of the sense of taste) 
Headache 
 
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Pneumonitis
Dyspnea 
 
SKIN AND SUBCUTANEOUS TISSUE DISORDERS 
Palmar-plantar erythrodysesthesia 
(burning or tingling discomfort in the 
hands 
and the soles of the feet) 
 
Alopecia (hair loss) 
 
Nail loss 
 
Pruritus (itchy skin)
 
Rash acneiform (eruptions on the skin)  
Rash maculo-papular (flat, 
red areas on the skin) 
 
 
VASCULAR DISORDERS 
Flushing (skin redness)
 


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CT scan risks: 
Each CT scan will give a radiation dose greater than that from typical natural background exposure, but less than 
the limit for radiation workers and well below the levels that are considered to be a significant risk of any harmful 
effects. 
EKG risks: 
With the echocardiogram, you may feel some discomfort when the technician pulls the electrodes off your chest 
similar to a Band-Aid. 
Blood Tests: 
For most people, needle punctures for blood tests do not cause any serious problems. However, they may cause 
fainting, bleeding, bruising, soreness, discomfort, dizziness, infections and/or pain at the injection site. There can 
be mild pain, soreness or some bleeding or bruising when blood is drawn. Rarely, an infection can happen where 
the needle was placed. Feeling dizzy or fainting can also happen, but may only last a few minutes after blood is 
drawn. If you take the blood thinner warfarin or Coumadin, you may have an increased risk of bleeding from the 
needle used to draw your blood. 
 
 
Reproductive risks: 
You should not become pregnant while on this study because the drug in this study could affect an unborn child. It 
is not known if the drugs used in this study are harmful to an unborn or breastfed baby. If you become pregnant 
while receiving these drugs, potential risks could include complications such as miscarriage or birth defects. It is 
not known if the study drugs are transferred to breast milk. Potential subjects who are breastfeeding will be 
required to discontinue nursing during treatment and for an additional 30 days following treatment. 
The drugs used in this study may cause fetal harm when administered to pregnant women. Animal studies have 
revealed evidence of harm to an unborn baby as well as birth defects. There are no controlled data in human 
pregnancy. If you are a female subject and you become pregnant while receiving this drug, potential risks could 
include complications such as miscarriage or birth defects. 
If you are of childbearing potential, you must use contraception during and for 30 days after the last dose of study 
drug. Examples of contraceptive methods with a failure rate of less than 1% per year include tubal ligation, male 
sterilization, hormonal implants, established, proper use of combined oral or injected hormonal contraceptives, 
and certain intrauterine devices. Alternatively, two methods (e.g., two barrier methods such as a condom and a 
cervical cap) may be combined to achieve a failure rate of less than 1% per year. Barrier methods must always be 
supplemented with the use of a spermicide. 
 
For more information about risks and side effects, ask your study doctor. 
 
There is always a chance that any medical treatment can harm you. The research treatments/procedures in this 
study are no different. In addition to risks described in this consent, you may experience a previously unknown 
risk or side effect. 
 
WILL YOU BENEFIT FROM TAKING PART IN THIS STUDY? 
We do not know if you will get any benefit from taking part in this study. Resistance to cancer chemotherapy is an 
obstacle to successful treatment of ovarian cancer. Lapatinib may decrease your body’s resistance to paclitaxel 
and enable the drug to better treat your ovarian cancer. If you take part in this study, information learned may help 
others with your condition. 
 
IF YOU DON’T WANT TO TAKE PART IN THE STUDY, ARE THERE OTHER CHOICES? 
If you do not want to take part in the study there are several standard chemotherapy treatments available. Standard 
chemotherapy drugs that are already FDA-approved for use in recurrent ovarian, primary peritoneal, or fallopian tube 
cancer include paclitaxel, topotecan, or pegylated liposomal doxorubicin (PLD). Bevacizumab in combination with 
chemotherapy (topotecan, paclitaxel or PLD) is also FDA-approved for women with platinum-resistant recurrent 
cancer listed above who received no more than two prior chemotherapy treatments. The study doctor will discuss 
the risks and benefits of the study treatment and the standard treatment options with you when you are deciding 


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whether or not to take part in this study. 
 
WHAT WILL IT COST YOU TO PARTICIPATE? 
You and/or your insurance company, Medicare, or Medicaid will be responsible for the costs of all care and 
treatment that you would normally receive for any conditions you may have. These are costs that are considered 
medically necessary and will be part of the care you receive even if you do not take part in this study. Your 
insurer, Medicare, or Medicaid, may agree to pay for the costs. However, a co-payment or deductible may be 
needed from you. The amount of this co-payment or deductible may be costly. 
The University of Kentucky may not be allowed to bill your insurance company, Medicare, or Medicaid for the 
medical procedures done strictly for research. 
Therefore, the sponsor, Markey Cancer Center, will pay for the following: 
 
Lapatinib tablets 
Blood testing for Pharmacokinetic and genetic analysis
 
 
WHO WILL SEE THE INFORMATION THAT YOU GIVE? 
When we write about or share the results from the study, we will write about the combined information. We will 
keep your name and other identifying information private. 
We will make every effort to prevent anyone who is not on the research team from knowing that you gave us 
information, or what that information is. At the University of Kentucky, data is stored at the Markey Cancer Center 
in locked facilities, and with limited access to records by designated research staff. The study doctor will assign 
you a unique code consisting of a series of numbers and only your unique code and your initials, and nothing that 
could identify you personally, will be entered into the study report forms. 
You should know that in some cases we may have to show your information to other people. For example, the law 
may require us to share your information with: 
 
a court or agencies, if you have a reportable disease/condition; 
 
authorities, if you report information about a child being abused; or if you pose a danger to yourself or 
someone else. 
 
To ensure the study Is conducted properly, Officials of the Food and Drug Administration, the National Cancer 
Institute, the University of Kentucky or its agents may look at or copy pertinent portions of records that identify 
you. 
 
CAN YOU CHOOSE TO WITHDRAW FROM THE STUDY EARLY? 
You can choose to leave the study at any time. You will not be treated differently if you decide to stop taking part 
in the study. 
If you choose to leave the study early, data collected until that point will remain in the study database and may not 
be removed. 
The investigators conducting the study may need to remove you from the study. You may be removed from the 
study if: 
you are not able to follow the directions, 
we find that your participation in the study is more risk than benefit to you, or 
the agency paying for the study chooses to stop the study early for a number of scientific reasons. 
The study intervention, medication, and/or device will no longer be provided to you and may not be available for 
purchase. This may occur for a number of reasons. 
 
ARE YOU PARTICIPATING, OR CAN YOU PARTICIPATE, IN ANOTHER RESEARCH STUDY AT THE SAME 
TIME AS PARTICIPATING IN THIS ONE? 
You may not take part in this study if you are currently involved in another research study. It is important to let the 


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investigator/your doctor know if you are in another research study. You should discuss this with the 
investigator/your doctor before you agree to participate in another research study while you are in this study. 
 
WHAT HAPPENS IF YOU GET HURT OR SICK DURING THE STUDY? 
If you believe you are hurt or if you get sick because of something that is due to the study, you should call 
Frederick Ueland, M.D. at 859-257-1613 (during business hours) or at 859-323-5321 (evenings and weekends) 
immediately. Frederick Ueland, M.D. will determine what type of treatment, if any, is best for you at that time. 
It is important for you to understand that the University of Kentucky does not have funds set aside to pay for the 
cost of any care or treatment that might be necessary because you get hurt or sick while taking part in this study. 
Also, the University of Kentucky will not pay for any wages you may lose if you are harmed by this study. 
 
Medical costs related to your care and treatment because of study-related harm will be your responsibility or may 
be paid by Medicare or Medicaid if you are covered by Medicare or Medicaid (If you have any questions regarding 
Medicare/Medicaid coverage you should contact Medicare by calling 1-800-Medicare (1-800-633-4227) or 
Medicaid 1-800-635-2570). 
 
A co-payment/deductible may be needed by your insurer or Medicare/Medicaid even if your insurer or 
Medicare/Medicaid has agreed to pay the costs. The amount of this co-payment/deductible may be costly. 
 
You do not give up your legal rights by signing this form. 
 
WILL YOU RECEIVE ANY REWARDS FOR TAKING PART IN THIS STUDY? 
You will not receive any rewards or payment for taking part in the study. 
 
WHAT IF NEW INFORMATION IS LEARNED DURING THE STUDY THAT MIGHT AFFECT YOUR DECISION 
TO PARTICIPATE? 
We will tell you if we learn new information that could change your mind about staying in the study. We may ask 
you to sign a new consent form if the information is provided to you after you have joined the study. 
 
WILL YOU BE GIVEN INDIVIDUAL RESULTS FROM THE RESEARCH TESTS? 
Generally, tests done for research purposes are not meant to provide clinical information. We will not provide 
you with individual research results. 
Do you give permission for us to contact you about research results or incidental findings that are determined to 
be important to you/your family’s health? (Incidental findings are unforeseen findings discovered during the 
course of the research that may affect you or your family’s health). 
Yes 
 No __________________ Initials 
You may also withdraw your consent to be contacted with information about research results or incidental 
findings by sending a written request to Frederick Ueland, M.D., Clinical Research Organization, 800 Rose 
Street, CC140 Roach Building, Lexington, KY 40536. 
 
WHAT ELSE DO YOU NEED TO KNOW? 
If you volunteer to take part in this study, you will be one of about 15 people to do so at the University of 
Kentucky. 
The Markey Cancer Center is providing financial support and/or material for this study. 
The information or specimens that you are providing will no longer belong to you. The research may lead to new 
clinical or educational knowledge, tests, treatments, or products. These products could have some financial value. 
There are no plans to provide financial payment to you or your relatives if this occurs. 
A description of this clinical trial will be available on ClinicalTrials.gov as required by U.S. Law. This website will 
not include information that can identify you. At most, the website will include a summary of the results. You can 
search this website at any time. 


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WILL YOUR INFORMATION (OR SPECIMEN SAMPLES) BE USED FOR FUTURE RESEARCH? 
Your information or samples collected for this study will NOT be used or shared for future research studies, 
even if we remove the identifiable information like your name, medical record number, or date of birth. 
 
AUTHORIZATION TO USE OR DISCLOSE YOUR IDENTIFIABLE HEALTH INFORMATION 
The privacy law, HIPAA (Health Insurance Portability and Accountability Act), requires researchers to protect your 
health information. The following sections of the form describe how researchers may use your health information. 
Your health information that may be accessed, used and/or released includes: 
• Demographic Information (your name, sex, race & age.)
• Your social security number 
• History and diagnosis of your disease 
• Specific information about treatments you have received 
• Past and present medical records pertaining to your health condition 
• Your entire research record 
• Your medical records held at the University of Kentucky that pertain to your health condition 
• Information about other medical conditions that may affect your treatment 
• Medical data, including physical examinations, laboratory test results, pathology results, and pregnancy 
test results 
• Information on side effects (adverse events) you may experience, and how these were treated 
• Long-term information about your general health status and the status of your disease 
• Tissue and/or blood samples, associated data related to the analysis of the samples
The Researchers may use and share your health information with: 
 
• The University of Kentucky’s Institutional Review Board/Office of Research Integrity. 
• Law enforcement agencies when required by law. 
• Authorized representatives of the University of Kentucky, UK Hospital, and Markey Cancer Center 
• Representatives of the Kentucky Cancer Registry 
• Representatives of the U.S. Food and Drug Administration (FDA) 
• The National Institutes of Health and its affiliates including the for Human Research Protections (OHRP) 
and the NCI (National Cancer Institute) and their affiliates 
• If necessary, your other healthcare providers who are not part of the study 
If you become pregnant anytime during the study or within 30 days after stopping the study drug, you must inform 
the study doctor. The study doctor must then report the outcome of your pregnancy to the Sponsor (and/or the 
FDA). 
You may not be allowed to participate in the research study if you do not sign this form. If you decide not to sign 
this form, it will not affect your: 
 
Current or future healthcare at the University of Kentucky; 
Current or future payments to the University of Kentucky; 
Ability to enroll in any health plans (if applicable); or 
Eligibility for benefits (if applicable). 
After signing the form, you can change your mind and NOT let the researcher(s) collect or release your 
health information (revoke the Authorization). If you revoke the authorization: 
 
You will send a written letter to Dr. Frederick Ueland c/o University of Kentucky / Department of 
Gynecologic Oncology / CRO / CC140 Roach Building / 800 Rose Street / Lexington, KY 40536-0293 to 
inform him of your decision. 
Researchers may use and release your health information already collected for this research study. 
 
Your protected health information may still be used and released should you have a bad reaction 
(adverse event). 
You will not be allowed to review the information collected for this research study until after the study is 
completed. When the study is over, you may have the right to access the information. 


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The use and sharing of your information has no time limit.
If you have not already received a copy of the Privacy Notice, you may request one. If you have any 
questions about your privacy rights, you should contact the University of Kentucky’s Privacy Officer 
between the business hours of 8am and 5pm EST, Monday-Friday at (859) 323-1184.
INFORMED CONSENT SIGNATURES
This consent includes the following:
Key Information Page
Detailed Consent
You will receive a copy of this consent form after it has been signed.
Signature of Principal Investigator orSub/Co-Investigator
_ 
Date
_
Printed name of [authorized] person obtaining informedconsent and
HIPAA authorization
Printed name of research subject
Signature of research subject