Table of Contents
- Clinical trials overview
- NCT05152147: HER2-positive gastroesophageal cancer study
- 2022-502196-31-00: Endometrial cancer study with Loperamide
- Main endpoints and what they mean
- Patient groups and participation focus
- Key trial terms
Clinical trials overview
The source data include two interventional studies, which means the researchers are testing treatments in people rather than only observing them.[1][2] One study is in gastroesophageal cancer and the other is in endometrial cancer.[1][2] 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.[2]
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).[1] The study is comparing zanidatamab plus chemotherapy, with or without tislelizumab, against trastuzumab plus chemotherapy.[1] 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.[1]
The trial is authorised and has an enrollment target of 919 people.[1] 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).[1] 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.[1]
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.[2] The trial record lists Loperamide as one of several interventions, along with placebo and other study drugs such as navtemadlin and ondansetron.[2] The study is marked as completed and includes 306 participants.[2]
The trial has two parts.[2] In Part 1, a safety review committee decides the Phase 3 dose for Part 2 based on safety data.[2] In Part 2, the study compares progression-free survival between navtemadlin and placebo, using review by an independent review committee.[2]
Main endpoints and what they mean
Endpoints are the main results a trial measures to see whether a treatment helps.[1][2] In the gastroesophageal cancer trial, the primary endpoints are progression-free survival and overall survival.[1] In the endometrial cancer trial, the first part focuses on safety review, and the second part measures progression-free survival.[2]
The phrase blinded independent central review means the scan results are checked by outside reviewers who do not know which treatment each person got.[1] The phrase independent review committee means a separate group checks the results in a neutral way.[2] These methods help make the trial results more reliable.[1][2]
Patient groups and participation focus
The first trial focuses on people with HER2-positive gastroesophageal cancer that is unresectable, locally advanced, recurrent, or metastatic.[1] The second trial focuses on people with advanced or recurrent endometrial cancer, and its title highlights TP53WT disease.[2] 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.[2]
Key trial terms
Authorised means the study has approval to proceed in the listed setting.[1]
Completed means the study has finished collecting its planned data.[2]
Placebo means a matching treatment with no active study drug, used for comparison.[2]
Maintenance therapy means treatment given to help keep the disease under control after earlier treatment steps.[2]
