Table of contents
- Trial overview
- Who the trial is for
- What researchers are measuring
- How response and safety are assessed
- Trial status and size
- What this means for patients
Trial overview
The trial titled SECAR 1c is studying SODIUM SELENITE PENTAHYDRATE in people with advanced carcinoma.[1] It is an interventional study, which means the research team gives a treatment and then measures the results.[1] 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.[1]
Who the trial is for
The source data says the study is for patients with advanced carcinoma.[1] No more detailed entry rules are listed in the trial record provided.[1] This means the available information only confirms the cancer type, not other factors such as age limits or prior treatments.[1]
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.[1] The brief summary says the treatment is a 99-hour intravenous selenite treatment, and the dose is measured as mg/m2/99 hours.[1] Researchers want to identify the dose that leads to the best tumor responses, especially partial response and complete response.[1]
The primary outcome also includes checking toxicity, which means unwanted harmful effects from treatment.[1] Toxicity is measured with the CTCAE V4.0 system, which is a standard way to grade side effects in clinical trials.[1] This helps the researchers compare safety results with previous SECAR studies.[1]
How response and safety are assessed
Tumor response is evaluated using RECIST 1.1 on CT scans taken before and after treatment.[1] RECIST 1.1 is a standard method that shows whether tumors have shrunk, stayed the same, or grown.[1] The study uses these scan results to judge whether the dose is effective enough while still staying safe.[1]
The trial also looks for dose-limiting toxicities, which are side effects serious enough to stop a dose from being used as planned.[1] 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.[1]
Trial status and size
The trial status is Authorised.[1] The planned enrollment is 25 patients, which is typical for an early dose-finding study.[1] Because this is a small Phase 1 trial, it is mainly designed to guide future research rather than prove final treatment benefit.[1]
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.[1] The study does not yet aim to prove long-term benefit for a large group of patients.[1] Instead, it focuses on early evidence about dose, response, and safety so later studies can be planned more carefully.[1]
