Fosrolapitant Combined With Palonosetron to Prevent Trastuzumab Rezetecan Related CINV
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTianjin Medical University Cancer Institute and Hospital
About this trial
This study is a prospective, single-arm, multicenter, exploratory clinical trial divided into a screening phase, a treatment phase, and a follow-up phase. The study aims to evaluate the efficacy and safety of foslorapitant palonosetron for injection in preventing nausea and vomiting caused by treatment with recanituzumab. All patients who meet the inclusion criteria and do not meet any exclusion criteria are eligible for enrollment in this study and are scheduled to receive targeted therapy, antiemetic treatment, and follow-up.
Dosage Regimen Eligible subjects will receive a prophylactic antiemetic regimen consisting of foslorapitant and palonosetron.
The dosage regimen is as follows:
Day 1 (D1): Foslorapitant and palonosetron (218 mg foslorapitant and 0.25 mg palonosetron hydrochloride), administered intravenously (IV) 1 hour prior to chemotherapy.
Observe for two treatment cycles (C1-C2); Starting from the first dose, record the patient's daily vomiting frequency, severity of nausea, and medication adherence.
Eligibility criteria
Qualifiers
Sign a written informed consent form and voluntarily enroll in this study;
Be at least 18 years of age; gender is not a restriction;
Be a patient scheduled to receive treatment with Trastuzumab Rezetecan;
Have an ECOG performance status score of 0-2;
Disqualifiers
Allergy to the study drug or its excipients;
Known contraindications to NK-1 receptor antagonists, 5-HT3 receptor antagonists, or dexamethasone;
Nausea or vomiting at the time of enrollment requiring treatment with antiemetics;
Use of medications with antiemetic effects within 2 days prior to the first dose;
Trial design
Treatments tested in this trial
- Fosrolapitant and Palonosetron Hydrochloride for Injection
Treatment groups
56 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov