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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
Florida Cancer Specialists-Lake Nona
Orlando, Florida, United States
RECRUITINGSTART Midwest
Grand Rapids, Michigan, United States
RECRUITINGWashington University
St Louis, Missouri, United States
RECRUITINGNebraska Cancer Specialists
Omaha, Nebraska, United States
RECRUITINGCarolina BioOncology Institute
Huntersville, North Carolina, United States
RECRUITINGTaylor Cancer Research Center
Maumee, Ohio, United States
RECRUITINGNEXT Oncology - Dallas
Dallas, Texas, United States
RECRUITINGSTART San Antonio
San Antonio, Texas, United States
RECRUITINGSTART Mountain Region
West Valley City, Utah, United States
RECRUITINGNEXT Virginia
Fairfax, Virginia, United States
RECRUITINGPart 1: Determine the maximum tolerated dose (MTD)
Determine the MTD of CP-383 in subjects with advanced solid tumors
Time frame: 21 days
Part 2: Evaluate the efficacy of CP-383 at the recommended phase 2 dose in selected tumor types
Objective response rate assessed by the investigator according to RECIST
Time frame: From enrollment through study completion, an average of 1 year
Part 1: Determine the pharmacokinetics parameters of CP-383
Assess standard PK parameters including Cmax
Time frame: From enrollment through study completion, an average of 1 year
Part 1: Determine the pharmacokinetics parameters of CP-383
Assess standard PK parameters including tmax
Time frame: From enrollment through study completion, an average of 1 year
Part 1: Determine the pharmacokinetics parameters of CP-383
Assess standard PK parameters including AUC
Time frame: From enrollment through study completion, an average of 1 year
Part 1: Assess safety and tolerability of CP-383 in participants with advanced solid tumors
Incidence and severity of Adverse events and changes in test results
Time frame: From enrollment through study completion, an average of 1 year
Part 2: Evaluate safety and tolerability of CP-383 at the recommended Phase 2 dose in selected tumor types
Incidence of AEs and changes in test results
Time frame: From enrollment through study completion, an average of 1 year
Part 2: Evaluate the efficacy of CP-383 at the recommended phase 2 dose in selected tumor types
Evaluate duration of response
Time frame: From enrollment through study completion, an average of 1 year
Part 2: Evaluate the efficacy of CP-383 at the recommended phase 2 dose in selected tumor types
Evaluate disease control as determined by Objective response of CR, PR or SD for at least 6 months
Time frame: From enrollment through study completion, an average of 1 year
Part 2: Evaluate the efficacy of CP-383 at the recommended phase 2 dose in selected tumor types
Evaluate progression free survival
Time frame: From enrollment through study completion, an average of 1 year
Part 2: Evaluate the efficacy of CP-383 at the recommended phase 2 dose in selected tumor types
Evaluate overall survival
Time frame: From enrollment through study completion, an average of 1 year
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