Norton Cancer Institute offers a large portfolio of clinical trials. Patients seeking access to cutting-edge trials come from out of state or even internationally, recognizing Louisville, Kentucky, as a hub for the advanced therapies. Norton Cancer Institute has been at the forefront of research. The institute has participated in many trials resulting in treatments approved by the Food and Drug Administration (FDA) and has delivered significant breakthroughs and life-altering results for enrolled participants.

According to ClinicalTrials.gov, which is a comprehensive resource for clinical trial information, Phase 1 trials constitute about 10% to 20% of all cancer-related trials. The proportion of Phase 1 trials among all clinical trials for cancer can vary, based on the types of therapies being developed and the current research focus. However, Phase 1 trials typically represent a significant portion of the total cancer clinical trials landscape.

Phase 1 trials play a critical role in cancer care for several reasons, despite being the earliest stage of clinical testing. Phase 1 trials provide an opportunity for:

• Safety and dosage determination: An early phase clinical trial, also known as a Phase 1 or sometimes Phase 1/2 trial, is the first step in testing a new drug or treatment in humans after it has shown promise in preclinical studies. They help identify adverse effects and establish a safety profile. Phase 1 trials investigate how the drug is absorbed, distributed, metabolized and excreted in the body. These trials also study the drug’s biological effects and mechanism of action. This helps in understanding how the drug works at the molecular and cellular levels.
  • Access to new treatments: Participation in Phase 1 trials can provide patients with access to therapies that are not yet available outside the clinical trial setting. Phase 1 trials often include patients with advanced cancer who have exhausted standard treatments. This can offer a potential therapeutic option for these patients.
  • Treatment innovation: While not the primary focus, Phase 1 trials sometimes provide early indications of efficacy. In cancer care, observing even limited responses can be promising and guide further development. These trials are particularly important for the development of innovative cancer treatments, such as targeted therapies, immunotherapies and combination therapies. The data collected in Phase 1 trials is critical for designing Phase 2 and 3 trials. It helps in refining the study protocols, selecting appropriate endpoints and ensuring patient safety. Phase 1 trial data is essential for gaining regulatory approval to proceed to later phases of clinical testing.

Your involvement in an early phase trial not only offers hope for improved treatments but also contributes to advancement in cancer care for future generations.

Phase 1 Trials Frequently Asked Questions