Solid Tumor MalignanciesColorectal CarcinomaSmall Cell Lung Cancer ( SCLC )Head and Neck (HNSCC)Bladder CancerNon-Small Cell Lung CancerPancreatic Cancer, Advanced or Metastatic
Investigational drug(s) / intervention(s)
CP-383
CP-383: Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
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
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Part 1: Determine the maximum tolerated dose (MTD) — 21 days Determine the MTD of CP-383 in subjects with advanced solid tumors
Part 2: Evaluate the efficacy of CP-383 at the recommended phase 2 dose in selected tumor types — From enrollment through study completion, an average of 1 year Objective response rate assessed by the investigator according to RECIST
Trial sites (13)
Facility
City
Region
Status
Sarah Cannon Research Institute at HealthONE
Denver
Colorado
Recruiting
Florida Cancer Specialists-Lake Nona
Orlando
Florida
Recruiting
START Midwest
Grand Rapids
Michigan
Recruiting
Washington University
St Louis
Missouri
Recruiting
Nebraska Cancer Specialists
Omaha
Nebraska
Recruiting
Carolina BioOncology Institute
Huntersville
North Carolina
Recruiting
Cleveland Clinic
Cleveland
Ohio
Recruiting
Taylor Cancer Research Center
Maumee
Ohio
Recruiting
University of Pennsylvania
Philadelphia
Pennsylvania
Recruiting
NEXT Oncology - Dallas
Dallas
Texas
Recruiting
START San Antonio
San Antonio
Texas
Recruiting
START Mountain Region
West Valley City
Utah
Recruiting
NEXT Virginia
Fairfax
Virginia
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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