A Multi-Center, Open Label, Phase 1/2 Study of CP-383, in Patients With Advanced or Metastatic Solid Tumors
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
Arms & interventions
- DrugCP-383
Novel anti-cancer agent inhibiting pyrimidine synthesis in cancer cells
Outcome measures
Primary
Part 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
Secondary
Part 1: Determine the pharmacokinetics parameters of CP-383
Time frame: From enrollment through study completion, an average of 1 year
Part 1: Determine the pharmacokinetics parameters of CP-383
Time frame: From enrollment through study completion, an average of 1 year
Part 1: Determine the pharmacokinetics parameters of CP-383
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
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
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
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
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
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
Time frame: From enrollment through study completion, an average of 1 year
Eligibility criteria
Study locations (13)
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
Florida Cancer Specialists-Lake Nona
Orlando, Florida, 32827
START Midwest
Grand Rapids, Michigan, 49546
Washington University
St Louis, Missouri, 63110
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
Carolina BioOncology Institute
Huntersville, North Carolina, 28078
Cleveland Clinic
Cleveland, Ohio, 44195
Taylor Cancer Research Center
Maumee, Ohio, 43537
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
NEXT Oncology - Dallas
Dallas, Texas, 75039
START San Antonio
San Antonio, Texas, 78229
START Mountain Region
West Valley City, Utah, 84119
NEXT Virginia
Fairfax, Virginia, 22031