Ph I/II Study of TPX-0005 for ALK/ROS1/NTRK1-3 Rearrangements in Adv Solid Tumors (TRIDENT-1)

UCI Specialty Area: Cancer

Principal Investigator: Misako Nagasaka

Official Title: A Phase I/II, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients with Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)

A Study On:

Brain and Nervous System

Breast

Colon

Kidney

Lip Oral Cavity and Pharynx

Lung

Melanoma skin

Other Digestive Organ

Other Skin

Rectum

Thyroid

Urinary Bladder

Study Description

This study has 2 parts (Phase 1 and Phase 2):

• Phase 1: Phase 1 of this research study is currently ongoing. It was the first time that the study drug, reprotrectinib, was given to humans.

o The purpose of Phase 1 was to determine the dose of repotrectinib to use in Phase 2 of the study. Phase 1 look at the side effects and response of tumors to different doses of repotrectinib. Phase 1 also looked at how different foods affect how repotrectinib gets into the body. Phase 1 includes the following sub-studies:

 Phase 1a, where the study drug is given under fasting conditions. You will need to fast 1 hour before and 2 hours after study drug administration. As of November 5th 2018, this part of the study is completed and will not enroll any new subjects

 Phase 1b is a Food Effect Sub-Study (a study within a study). You may be asked to participate in the Food Effect Sub-Study. The purpose of the Food Effect Sub-Study is to determine the effect of high-fat, high-calorie food on a single dose of repotrectinib (how much and how fast repotrectinib gets into the body after a meal). As of November 5th 2018, this part of the study is completed and will not enroll any new subjects.

 Phase 1 also includes a study of repotrectinib when administered continuously with food, where you will take every dose of the study drug with a standard meal, called Phase 1c.

• Phase 2: You are being asked to participate in Phase 2 of this study (not Phase 1). The purpose of Phase 2 is to determine, more specifically, whether repotrectinib works, especially in groups of subjects who have the various tumor gene rearrangements mentioned above. Phase 2 will also continue to look at the side effects as well as how repotrectinib is absorbed into the body.

The Phase 2 portion of the study will evaluate the anti-cancer activity of repotrectinib at the dose listed below:

• 160 mg once a day for 14 days that may increase to 160 mg twice a day based on the drug’s tolerability

The study doctor will assess and decide if your dose should be increased or decreased.

No study procedures related to this study will be performed until you have signed this Informed Consent Form. A copy of the signed Informed Consent Form will be given to you to keep.

Eligibility

You can participate in this study if you

• Are a male or female subject, 18 years of age or older

• Are able to adhere to the study visit schedule and other protocol requirements

• Have a confirmed diagnosis of locally advanced or metastatic solid tumor that has a specific gene rearrangement

You cannot participate in this study if you

• Are pregnant or breastfeeding, or intending to become pregnant during the study

• Are currently participating in another therapeutic clinical trial

• Have a known active infection (bacterial, fungal, or viral, including human immunodeficiency virus positivity).

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Interested in Participating in this Trial?

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

Please read the information below and ask questions about anything that you do not understand. A
researcher listed above will be available to answer your questions.

You are being asked to participate in a clinical research potential participant database to identify
potential clinical research studies you may be eligible for. Participation in this database is voluntary.
You may choose to skip any question. You may refuse to participate or discontinue your involvement
at any time without penalty or loss of benefits. You are free to withdraw from this database at any
time. If you decide to withdraw from this database you should notify the research team
immediately.

You are eligible to participate in this study if you may be interested in participating in a research trial at UCI Health

We would like to interview you to learn more about your eligibility for current clinical research studies at UCI. The interview will last about 5-30 minutes, depending on the extent of your medical history.

Possible risks/discomforts associated with the database are hearing about potential clinical research studies that may not be of interest to you, invasion of your privacy, or a potential breach of confidentiality.

There are no direct benefits from participation in the database. However, this database may help inform you on clinical research studies that you may be eligible for. Participation in UCI clinical research studies help us gain important data and knowledge that may lead to improved treatment options for people with similar conditions to you in the future.

There are no alternative procedures available. The only alternative is not to participate in this study.

There is no compensation for your participation in this database.

There is no cost to you for participation in this database.

All information collected will be stored confidentially in a world-class securely-hosted application, “RealTime CTMS,” with robust data protections and encryption. This application has HIPAA compliant architecture and application rules to ensure data privacy and regulatory compliance.

Researchers will use your information to assess your eligibility for current and future clinical research studies at UCI. You may opt out at any time.

The research team, authorized UCI personnel, and regulatory entities, may have access to your study records to protect your safety and welfare.

While the research team will make every effort to keep your personal information confidential, it is possible that an unauthorized person might see it. We cannot guarantee total privacy.

Future Research Use
Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information

Data Retention - In accordance with UC Office of the President policy, information will be retained for 10 years after the end of the calendar year in which the research is completed.

If, during the course of this study, significant new information becomes available that may relate to your willingness to continue to participate, this information will be provided to you by the research team listed at the top of the form.

If you have any comments, concerns, or questions regarding the conduct of this research please contact the researchers listed at the top of this form

Please contact the UCI Institutional Review Board by phone, (949) 824-8170, by e-mail at IRB@research.uci.edu or at 160 Aldrich Hall, Irvine, CA 92697-7600 if you are unable to reach the researchers listed at the top of the form and have general questions; have concerns or complaints about the research; have questions about your rights as a research subject; or have general comments or suggestions.

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