Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07485569
Brief Summary:
Rationale Patients with advanced thyroid cancer often have very few treatment options, and standard therapies usually cannot cure the disease. Some types grow and spread quickly and do not respond to surgery and radioactive iodine. For patients with other types, existing drugs may slow the disease but can cause strong side effects, limiting their usefulness. This study is testing a new personalized approach that uses genetic tumor information to identify combinations of existing approved drugs that may work better together. The idea is that targeting several connected networks in the tumor at the same time may be more effective than standard treatments that focus on a single target.
Objective The main objective is to study if it is feasible and safe to give patients individualized drug combinations selected based on their tumor genetic profile. The secondary objective is to find out whether these treatments can help control the growth of the patient tumors or stop them from getting worse. Main trial endpoints
* Feasibility: How many patients can start the individualized treatment.
* Safety: How many patients experience side effects from the treatment. Secondary trial endpoints
* Effectiveness: How many patients achieve disease control (stable disease, partial response, or complete response) after three months of treatment.
* Other outcomes (exploratory): additional feasibility outcomes, patient-and caregiver-reported outcomes, other effectivity outcomes, and biological signals in the blood. Trial design This is an exploratory, single-arm phase I umbrella trial. Each patient receives a personalized treatment based on the genetic profile of their tumor. The study focuses on understanding feasibility and safety. Each participant will be in the study for approximately 4 months. The first month is used to examine the tumor of the patient and select the best personalized treatment. Once the treatment is chosen and both the patient and their doctor agree, the patient will receive the treatment for three months. During treatment, patients will have regular check-ups, blood tests, scans, and questionnaires to monitor safety and see how well the treatment is controlling the tumor.
Trial population Inclusion criteria: Up to 10 adult patients (over 18 years) with advanced or metastatic thyroid cancer who have no other standard treatment options. Exclusion criteria: Pregnant women and patients eligible for urgent local treatments.
Interventions
* Tumor samples (from surgery or biopsy) will be analyzed to identify genetic features and potential drug targets.
* A multidisciplinary study board will select an individualized combination of approved drugs that are expected to be safe and potentially effective.
* Patients and their treating physicians will decide together whether to start the treatment.
* Monitoring during treatment includes physical exams, blood tests, imaging scans, and patient questionnaires about symptoms and quality of life
Study:
NCT07485569
Study Brief:
Protocol Section:
NCT07485569