A Multi-Center, Open Label, Phase I/II Study of CP-383, in Patients With Advanced or Metastatic Solid Tumors

Study Identifier:
TAS-CP383-01
CT.gov Identifier:
NCT07030257
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

The goal of this clinical trial is to learn if an investigational drug CP-383 works to treat advanced cancer. It will also learn about the safety of CP-383. The main questions if aims to answer are:

  • Does CP-383 slow or stop the growth of cancer in patients with advanced cancer
  • What medical problems do participants have when taking CP-383 Researchers will test CP-383 in all kinds of cancers at various dose levels to determine what the best dose is to study further. Researchers will also see if certain cancers that have gene mutations respond better to CP-383

Participants will:

  • Take CP-383 every day by mouth until the researcher learns whether CP-383 is helping slow or reduce the cancer growth
  • Visit the clinic weekly for the first 6 weeks for checkups and tests
  • Visit the clinic every 3 weeks thereafter for checkups and tests
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
  • Bowel (Colorectal)
  • Small Cell Lung
  • Head & Neck
  • Bladder
  • Non-Small Cell Lung Cancer
  • Pancreas
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Dose Level 1
    • Read More
  • Drug: Experimental: Dose Level 2
  • Drug: Experimental: Dose Level 3
  • Drug: Experimental: Dose Level 4
  • Drug: Experimental: Dose Level 5
  • Drug: Experimental: Expansion Arm 1
  • Drug: Experimental: Expansion Arm 2
  • Drug: Experimental: Expansion Arm 3
  • Drug: Experimental: Expansion Arm 4
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • * Measurable or non measurable cancer that the research can assess for changes
    • * Not eligible or able to take existing standard therapies for cancer
    • * Availability of a part of a tumor for laboratory testing or willing to have a safe biopsy taken from a tumor
    • * Diagnosed with locally advanced, recurrent or metastatic incurable disease
    • * Part 1: any solid tumor (with the exception of brain cancer) that has progressed, standard therapy is no longer or has not helped the cancer, or is too toxic and for whom a clinical trial is an option for continued treatment
    • * Part 1: specific advanced, metastatic tumor types will also be enrolled: colorectal cancer, small cell lung cancer, head and neck cancer, non-small cell lung cancer, pancreatic cancer, bladder cancer - some of these will have a specific gene mutation in the cancer
    • * Part 1: selected solid tumor cancer types (with the exception of brain cancers) that have a specific gene mutation in the cancer
    • * Part 2: specific advanced, metastatic tumor types will also be enrolled: colorectal cancer, small cell lung cancer, head and neck cancer - some of these will have a specific gene mutation in the cancer
    • _ Part 2: selected solid tumor cancer types (with the exception of brain cancers) that have a specific gene mutation in the cancer
    • * Adequate blood and urine lab tests
    • * Women and men of childbearing potential with adequate contraception
    • * Provides written informed consent
    • * Willing to comply with the requirements of the protocol
    Exclusion criteria
    • * Inability to swallow pills
    • * Known history of HIV, HCV, HBV unless cured, controlled with undetectable viral load
    • * Active tumor in the brain
    • * Clinically significant liver disease
    • * Significant gastrointestinal diseases
    • * History of other cancer within past 5 years with certain exceptions for cancers that are likely cured
    • * Significant cardiac disease
    • * Other diseases that are not well controlled that could make taking the drug unsafe
    • * pregnant or lactating females
    • * Exposure to certain anti-cancer or other drugs within a certain period before the start of study drug

    Clinical Study Information for Healthcare Providers

    By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Kyriakos Papadopoulos
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Bowel (Colorectal)
    Small Cell Lung
    Head & Neck
    Bladder
    Non-Small Cell Lung Cancer
    Pancreas
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Sreenivasa Chandana
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Bowel (Colorectal)
    Small Cell Lung
    Head & Neck
    Bladder
    Non-Small Cell Lung Cancer
    Pancreas
    Location
    START Mountain Region
    West Valley City, UT, United States, 84119
    Investigator
    William McKean
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Bowel (Colorectal)
    Small Cell Lung
    Head & Neck
    Bladder
    Non-Small Cell Lung Cancer
    Pancreas