This trial aims to test the effectiveness of a new drug called RRx-001 in patients with small cell carcinoma. The main outcome measured will be how long the patients go without cancer growing or spreading (progression-free survival). The study is being conducted in the United States, Orange City, Florida.
RRx-001 is a new experimental drug. It is a class of drug called a “checkpoint inhibitor.” It is thought that using this type of drug will make the body less resistant to other types of medicine. This is especially for medicine that targets the immune system. It is not known if adding RRx-001 to standard treatment for small cell carcinoma will be beneficial.
This trial aims to find out if adding RRx-001 to standard chemotherapy for small cell carcinomas] is better than just using standard chemotherapy alone. The outcomes measured will be progression-free survival overall survival and overall response rate.
Who are they looking for?
120 participants with confirmed small cell carcinoma are needed. To be included in this trial, patients must have been treated with a platinum-based chemotherapy before.
Patients cannot be in the trial if they have symptoms from cancer in the brain. Patients cannot be in the trial if they have another severe illness like an infection, uncontrolled diabetes, mental conditions, or heart problems. Patients will be excluded from the trial if they have previously been allergic to any of the study medication. Patients in the trial cannot be pregnant or breastfeeding.
How will it work
This trial will consist of two groups. One group will receive treatment with carboplatin (Paraplatin) or cisplatin (Platinol) plus etoposide (Etopophos; Toposar). This will go on for up to 4 cycles of three weeks. The second group will receive treatment with RRx-001 for three weeks. This group will then go on to receive the same treatment as the first group.
Patients will be followed up to 12 months. Survival without cancer growing or spreading, overall survival and overall response will be the main outcomes evaluated.