In short
Clinical trials are investigating Loperamide as part of studies in cancer care. These trials look at safety and effectiveness in specific patient groups, including people with gastroesophageal adenocarcinoma and people with advanced or recurrent endometrial cancer. The studies also measure outcomes such as progression-free survival and overall survival.
Key points
- Clinical trials involving Loperamide are listed in two cancer studies. One trial is a Phase 3 study in people with HER2-positive advanced or metastatic gastroesophageal adenocarcinoma. The other is a Phase 2/3 study in advanced or recurrent endometrial cancer and includes a Part 1 safety review and a Part 2 efficacy comparison. The main outcomes include progression-free survival, overall survival, and safety review results. One trial is authorised and the other is completed. The available data show that Loperamide appears as one intervention in the endometrial cancer study.
Clinical trials overview
The source data include two interventional studies, which means the researchers are testing treatments in people rather than only observing them. One study is in gastroesophageal cancer and the other is in endometrial cancer. Loperamide is listed as an intervention in the endometrial cancer study, but the trial focus is on the study design and outcomes rather than on Loperamide alone.
NCT05152147: HER2-positive gastroesophageal cancer study
This is a Phase 3 trial in people with HER2-positive advanced gastric and esophageal cancers, also called gastroesophageal adenocarcinoma (GEA). The study is comparing zanidatamab plus chemotherapy, with or without tislelizumab, against trastuzumab plus chemotherapy. The target group includes people with unresectable, locally advanced, recurrent, or metastatic disease, which means the cancer cannot be removed by surgery, has come back, or has spread.
The trial is authorised and has an enrollment target of 919 people. Its main goals are to compare progression-free survival (time without the cancer getting worse) and overall survival (how long people live after treatment starts). Progression-free survival is measured by RECIST 1.1 and reviewed by a blinded independent central review, which means experts assess scans without knowing which treatment a person received.
2022-502196-31-00: Endometrial cancer study with Loperamide
This study is in people with advanced or recurrent endometrial cancer, and the title says it is a Phase 2/3 study of navtemadlin as maintenance therapy in TP53WT disease. The trial record lists Loperamide as one of several interventions, along with placebo and other study drugs such as navtemadlin and ondansetron. The study is marked as completed and includes 306 participants.
The trial has two parts. In Part 1, a safety review committee decides the Phase 3 dose for Part 2 based on safety data. In Part 2, the study compares progression-free survival between navtemadlin and placebo, using review by an independent review committee.
Main endpoints and what they mean
Endpoints are the main results a trial measures to see whether a treatment helps. In the gastroesophageal cancer trial, the primary endpoints are progression-free survival and overall survival. In the endometrial cancer trial, the first part focuses on safety review, and the second part measures progression-free survival.
The phrase blinded independent central review means the scan results are checked by outside reviewers who do not know which treatment each person got. The phrase independent review committee means a separate group checks the results in a neutral way. These methods help make the trial results more reliable.
Patient groups and participation focus
The first trial focuses on people with HER2-positive gastroesophageal cancer that is unresectable, locally advanced, recurrent, or metastatic. The second trial focuses on people with advanced or recurrent endometrial cancer, and its title highlights TP53WT disease. Together, these studies show that Loperamide appears in trial data connected to cancer research, especially in a study that also tests other medicines and placebo.
Key trial terms
- Authorised means the study has approval to proceed in the listed setting.
- Completed means the study has finished collecting its planned data.
- Placebo means a matching treatment with no active study drug, used for comparison.
- Maintenance therapy means treatment given to help keep the disease under control after earlier treatment steps.