Study of CP-383 in Patients With Advanced or Metastatic Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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 |
Other trials for the same condition
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.
View NCT07030257 on ClinicalTrials.gov ↗ ← All trials in the USA