Table of contents

• Trial overview
• Conditions and patient groups
• Trial phases and study designs
• Main endpoints and what they mean
• Selected trial details
• What this means for patients

Trial overview

The trial data show Aprepitant being studied in several interventional studies, which means researchers give a treatment and then measure the results.^[1] In these trials, Aprepitant is usually part of a larger treatment plan, often to help prevent nausea and vomiting during chemotherapy or after surgery.^[4][7]

The studies in the source data include both cancer trials and symptom-control trials, with patient groups ranging from children receiving chemotherapy to adults with different cancers and people having bariatric surgery.^[4][7][8]

Conditions and patient groups

Aprepitant appears in trials for chemotherapy-induced nausea and vomiting, including delayed nausea and vomiting in children and nausea and vomiting in adults with cancer.^[4][7] In these studies, the goal is to see whether Aprepitant helps control symptoms during or after cancer treatment.

It is also included in a trial on postoperative nausea and vomiting after bariatric surgery, where the aim is to lower the chance of nausea and vomiting after an operation.^[8]

Several cancer studies list Aprepitant as part of supportive care while testing another main treatment. These include studies in very high-risk T-lineage acute lymphoblastic leukemia, penis carcinoma, extensive-stage small cell lung cancer, recurrent or persistent uterine serous carcinoma, high-grade serous ovarian cancer, non-metastatic HER2-positive breast cancer, treatment-naïve myelofibrosis, and JAK inhibitor-naïve myelofibrosis with moderate thrombocytopenia.^{[1][2][3][5][6][9][10][11]}

Trial phases and study designs

The Aprepitant-related trials in the source data are in Phase 1, Phase 2, and Phase 3.^{[1][2][3][4][5][6][7][8][9][10][11]} Phase 1 studies mainly focus on safety and how well a treatment is tolerated, while Phase 2 and Phase 3 studies look more closely at whether the treatment works and how it compares with other approaches.

One Phase 3 study in children uses a double-blind placebo-controlled crossover randomized design, which means neither the patient nor the study team knows which treatment is given at the time, a placebo is used for comparison, and each child receives both study approaches in different chemotherapy cycles.^[4] Another Phase 3 study in bariatric surgery compares Aprepitant with placebo to see whether it lowers postoperative nausea and vomiting.^[8]

Main endpoints and what they mean

The main endpoint in the chemotherapy nausea and vomiting studies is usually complete response, which means no vomiting, no retching, and no rescue medication during the study time window.^[4][7] This is a clear way to measure whether symptoms were fully controlled.

In the bariatric surgery trial, the primary outcomes include the incidence of postoperative nausea and vomiting, the severity of symptoms measured by rating scales, and the use of rescue medication.^[8] These outcomes show both how often symptoms happen and how serious they are.

In the cancer studies where Aprepitant is part of supportive care, the main endpoints are mostly cancer response measures. These include MRD negativity after induction in very high-risk T-ALL, survival without locoregional lymph node recurrence in penis carcinoma, dose-limiting toxicities, adverse events, and objective response rate in lung cancer, and pathologic complete response in HER2-positive breast cancer.^[1][2][3][9]

Some myelofibrosis studies measure spleen volume reduction and symptom score changes, which help show whether the treatment improves disease burden and daily symptoms.^[10][11]

Selected trial details

Children with delayed chemotherapy-induced nausea and vomiting. The DAVINCY trial studied whether longer prophylaxis with (fos)Aprepitant could improve delayed nausea and vomiting control in children receiving moderate or highly emetogenic chemotherapy.^[4] The study compared the usual 3-day regimen with a longer regimen during the full chemotherapy course, and the main outcome was complete response in the 24 to 72 hours after the last chemotherapy dose.^[4]

Adults with cancer receiving chemotherapy. Another Phase 2 study tested LY3537021 with other antiemetic treatments and included Aprepitant among the study drugs used for nausea and vomiting control.^[7] Its main outcome was complete response in the delayed phase of chemotherapy-induced nausea and vomiting.^[7]

Patients after bariatric surgery. The postoperative nausea and vomiting trial studied whether Aprepitant can reduce nausea and vomiting after surgery, with outcomes based on how often symptoms occurred, how severe they were, and whether rescue medicine was needed.^[8]

Supportive care in cancer treatment trials. In several oncology studies, Aprepitant is listed alongside other medicines used during treatment, but the main trial question is about the cancer therapy itself.^{[1][2][3][5][6][9][10][11]} For example, the leukemia study measures MRD negativity after induction, and the breast cancer trial measures pathologic complete response after neoadjuvant treatment.^[1][9]

What this means for patients

From the trial records, Aprepitant is being studied mainly as a way to help control nausea and vomiting in people receiving chemotherapy or having surgery.^[4][7][8] The studies cover both younger and older patients, and they use different research designs depending on the condition being treated.

For patients, the most important trial details are the condition being studied, the age group, the study phase, and the main outcome being measured.^[1][4][8] In the source data, Aprepitant is not the main cancer treatment being tested; instead, it is usually part of the supportive treatment plan around the main study drug or surgery.^[1][7][9]