Endometrial Cancer Study

Frequently Asked Questions (FAQ)

This section will help answer some of the important questions you may have.

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Why is this clinical study being conducted?

The PIK-201 Study is testing two oral investigational drugs called serabelisib and sapanisertib that are given in combination with a chemotherapy drug, paclitaxel. By combining these oral investigational drugs, researchers hope to shut down cancer growth more effectively. This study is exploring how these investigational drugs work together in people with endometrial cancer.

There is also an optional substudy that includes an insulin-suppressing diet (ISD) to be consumed while on the study treatment instead of your usual diet. The study diet includes meals delivered to your home and personalized coaching with nutrition coaches.

How do the investigational drugs work?

The oral investigational drugs being tested are serabelisib (FTH-001), a PI3K inhibitor, and sapanisertib (FTH-003), an mTOR inhibitor.

Sapanisertib has been shown to block a protein in the body that regulates cell growth. We are testing to see if it may interfere with this protein and possibly slow or stop cancer cells from living and growing.

Serabelisib has been shown to block the activity of a different protein that regulates growth in many different types of tumors. We are testing to see if it may stop tumor cells (cancer cells) from growing and living.

Paclitaxel is a chemotherapy drug widely used in the treatment of many kinds of cancer. It is often combined with other chemotherapy drugs. While it is used extensively to treat endometrial cancer, paclitaxel is not specifically approved by regulatory authorities for this use and therefore is considered an investigational drug in this study. A substudy is also being conducted in up to 50% of participants to see if adding an insulin-suppressing diet will further stop or slow disease return.

How long will my participation in this clinical study last?

This study will be conducted over approximately 5 years in 28-day cycles. That means that the investigational drugs being tested are given in a schedule that repeats every 28 days. The duration of your participation in this study may vary, but your study doctor can answer any questions you have.

You may be able to continue getting the investigational drugs for as long as the study doctor feels it is safe for you to do so, until your cancer comes back, or you decide to stop participating.

Would I have to follow the diet to participate in the study?

No, the diet is part of an optional substudy and will not affect your participation in the main study.

What kind of foods does the study diet contain?

The study diet is low in carbs and high in fat. Instead of foods like bread and pasta, you would have things like meat, cheese, eggs, nuts, and vegetables. Your coach may suggest alternative options from the menu, send meal kits, or help you create a home-cooked version of the diet using your own ingredients.

How do I decide if this clinical study is right for me?

Before you agree to participate, the study team will review all aspects of the clinical study with you. If you decide to participate, you will be given a document called an Informed Consent Form that provides, in writing, information on the clinical study’s purpose, possible benefits and risks, assessments, procedures, and more. No study-related procedures can be done until you sign the Informed Consent Form. You will have the opportunity to ask questions of the study team so you can decide if participating is right for you.

Privacy, Stopping Participation, Costs, and Permission

Can I leave the clinical study early?

Yes, participation in clinical studies is always voluntary. If you decide to participate, you are free to withdraw at any time, for any reason, without any penalty or effect on your future medical care. If you do decide to leave the clinical study early, you should talk to your study doctor about leaving so that they can schedule a final evaluation.

You may also be contacted by the study doctor or study staff by phone to check on you. Data and samples collected from you prior to your withdrawal will continue to be used for the study, but no new data or samples will be collected once you leave the study.

Will I get paid to participate?

No. However, study-related care and the investigational drugs will be provided at no charge. You may qualify for reimbursement related to study visits. The study team can provide more information about this.

Do I need my doctor’s permission to participate?

No, your doctor does not have to give you permission to participate. However, feel free to talk to your doctor about participating in the PIK-201 Study. With your permission, the study doctor will keep your regular doctor updated about your condition during the clinical study.

About Clinical Studies

What is a clinical study?

A clinical study, also known as a research study or clinical trial, is a scientific study that evaluates the safety and efficacy of an investigational drug as well as how your body processes that medicine. Qualified doctors, nurses and other medical professionals are responsible for conducting the clinical study.

It is only through the completion of clinical studies that investigational drugs can be evaluated and, if proven safe and efficacious, approved for a particular use. Different regulatory bodies in different countries (such as the US Food and Drug Administration [FDA]) will provide this approval after a thorough review. In order to ensure that a clinical study is ethical, and that participants’ rights are protected, Institutional Review Boards (IRBs) or Ethics Committees (ECs) review the detailed plans and goals for the clinical study.

What is an investigational drug?

An investigational drug is a medicine that has not been approved for prescription use by regulatory or health authorities, such as the FDA or European Medicines Agency (EMA).

Who can participate in a clinical study?

Only participants who meet all the required eligibility criteria for the clinical study may take part. The study team will review your medical history and current medical status against the eligibility criteria to determine if you are eligible. You may also be asked to provide information from your medical records to help the study team determine whether or not you may be eligible.

What happens to my personal information?

The information you provide will not be shared with anyone who is not directly associated with the PIK-201 Study without your permission, except as required by law or as set forth in the Informed Consent Form, the document you would sign before participating in the clinical study.

Endometrial cancer may be back, but
we’re doing everything we can to make sure it doesn’t win

About the PIK-201 Study

You may be able to participate if you:*

Why participate?

Frequently Asked Questions (FAQ)

Privacy, Stopping Participation, Costs, and Permission

About Clinical Studies

Endometrial cancer may be back, but we’re doing everything we can to make sure it doesn’t win

About the PIK-201 Study

You may be able to participate if you:*

Why participate?

Frequently Asked Questions (FAQ)

Privacy, Stopping Participation, Costs, and Permission

About Clinical Studies

Endometrial cancer may be back, but
we’re doing everything we can to make sure it doesn’t win