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A Phase III, Multicenter, Randomized, Open-label, Study Evaluating the Efficacy and Safety of Nanvuranlat in Patients with Previously Treated Advanced Biliary Tract Cancer

UCI Specialty Area: Cancer
Principal Investigator: Farshid Dayyani
A Study On:
Liver
Other Digestive Organ

Study Description

This study is designed to 1) select a dose regimen for continued development and 2) evaluate nanvuranlat versus Physicians Best Choice (PBC) (FOLFOX, FOLFIRI, or Best Supportive Care (BSC)) in participants aged 18 years and over with BTC. Participants enrolling in Part A the trial will be randomly assigned to receive 1 of 3 nanvuranlat dose regimens or PBC. In Part B, participants will be randomly assigned to receive nanvuranlat or PBC. Participants will receive treatment every 2 weeks for as long as they do not experience safety issues, or their cancer gets worse, and the study doctor feels they should stop treatment. Health measurements including physical examinations, vital signs, ECGs, and safety laboratory tests will be performed to monitor safety, and tumor imaging will be performed to monitor cancer response to treatment. Other exploratory makers will be measured to better understand how nanvuranlat works.

Eligibility

Inclusion Criteria

  • at least 18 years of age inclusive at the time of signing the informed consent

-Histologic or cytologic diagnosis of Biliary Tract Cancer (BTC)

-Has received 1 prior appropriate platinum (cisplatin, carboplatin, or oxaliplatin)-based therapy for advanced disease (locally advanced or metastatic) with or without a mAB targeting PD-1 or PD-L1.

Exclusion Critieria

-Woman of child bearing potential who is pregnant, lactating, or discontinued lactation less than 12 weeks prior to screening, or who plans to become pregnant or initiate lactation during the study

-Received radiotherapy to metastatic sites within 2 weeks of Cylce 1 Day 1. Patients must have recovered from all radiation-related toxicities and not require corticosteroids. A 1-week washout is permitted for palliative radiation with a limited port less than or equal to 2 weeks of radiotherapy to non-CNS disease

-Underwent major surgery less than 3 weeks before screening and has not recovered adequately from the procedure and/or any complications from the surgery prior to starting study intervention.

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Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Eric Vilain, MD, PhD
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
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  • You are being asked to participate in a clinical research potential participant database to identify
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    You may choose to skip any question. You may refuse to participate or discontinue your involvement
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  • You are eligible to participate in this study if you may be interested in participating in a research trial at UCI Health
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  • 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.
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  • 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
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What is an IRB? An Institutional Review Board (IRB) is a committee made up of scientists and nonscientists. The IRB’s role is to protect the rights and welfare of human subjects involved in research. The IRB also assures that the research complies with applicable regulations, laws, and institutional policies. UCI