In short
SODIUM SELENITE PENTAHYDRATE is being studied in clinical trials for people with advanced carcinoma. These trials look at the best dose, treatment response, and safety, with a focus on finding a dose that works well without causing dose-limiting toxicity.
Key points
- SODIUM SELENITE PENTAHYDRATE is being studied in a Phase 1 trial for people with advanced carcinoma. The study is authorised and plans to enroll 25 patients. Researchers want to find the best dose for a 99-hour intravenous treatment. They will measure tumor response on CT scans using RECIST 1.1 and track toxicity using CTCAE V4.0. The main goal is to find a dose that gives the best response without dose-limiting toxicity.
Trial overview
The trial titled SECAR 1c is studying SODIUM SELENITE PENTAHYDRATE in people with advanced carcinoma. It is an interventional study, which means the research team gives a treatment and then measures the results. The study is in Phase 1, so its main purpose is to find the best dose and check safety in a small group of patients.
Who the trial is for
The source data says the study is for patients with advanced carcinoma. No more detailed entry rules are listed in the trial record provided. This means the available information only confirms the cancer type, not other factors such as age limits or prior treatments.
What researchers are measuring
The main goal is to find the optimal dose, meaning the dose that gives the best clinical response without dose-limiting toxicity. The brief summary says the treatment is a 99-hour intravenous selenite treatment, and the dose is measured as mg/m2/99 hours. Researchers want to identify the dose that leads to the best tumor responses, especially partial response and complete response.
The primary outcome also includes checking toxicity, which means unwanted harmful effects from treatment. Toxicity is measured with the CTCAE V4.0 system, which is a standard way to grade side effects in clinical trials. This helps the researchers compare safety results with previous SECAR studies.
How response and safety are assessed
Tumor response is evaluated using RECIST 1.1 on CT scans taken before and after treatment. RECIST 1.1 is a standard method that shows whether tumors have shrunk, stayed the same, or grown. The study uses these scan results to judge whether the dose is effective enough while still staying safe.
The trial also looks for dose-limiting toxicities, which are side effects serious enough to stop a dose from being used as planned. In simple terms, the researchers are trying to find a dose that helps the cancer most while causing too much harm as rarely as possible.
Trial status and size
The trial status is Authorised. The planned enrollment is 25 patients, which is typical for an early dose-finding study. Because this is a small Phase 1 trial, it is mainly designed to guide future research rather than prove final treatment benefit.
What this means for patients
For patients with advanced carcinoma, this trial is mainly about learning whether SODIUM SELENITE PENTAHYDRATE can be given at a dose that is both useful and tolerable. The study does not yet aim to prove long-term benefit for a large group of patients. Instead, it focuses on early evidence about dose, response, and safety so later studies can be planned more carefully.