- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07726433
Fosrolapitant Combined With Palonosetron to Prevent Trastuzumab Rezetecan Related CINV
A Multicenter, Exploratory Clinical Study of the Efficacy and Safety of Phentolamine and Palonosetron for the Prevention of Nausea and Vomiting Associated With Recom-Trastuzumab Therapy
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Zhansheng Jiang Tianjin Cancer Hospital Airport Hospital
- Telefonnummer: 022-23340123
- E-mail: zhjiang@tmu.edu.cn
Studiesteder
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Tianjin, Kina
- Rekruttering
- Tianjin Cancer Hospital Airport Hospital
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Kontakt:
- Zhansheng Jiang Tianjin Cancer Hospital Airport Hospital
- Telefonnummer: 022-23340123
- E-mail: zhjiang@tmu.edu.cn
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- 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;
- No ascites or pleural effusion requiring drainage;
- No gastrointestinal obstruction, such as pyloric stenosis or intestinal obstruction;
- Expected survival of ≥12 weeks;
Good organ and bone marrow function, defined as follows:
Hematologic System (No blood transfusions or treatment with hematopoietic growth factors within the past 14 days)
- Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹/L
- Platelets (PLT) ≥ 100×10⁹/L
- Hemoglobin (Hb) ≥ 90 g/L Liver Function
- Total Bilirubin (TBIL) ≤ 1.5×ULN (For patients with Gilbert's syndrome: ≤ 3×ULN)
- Alanine Aminotransferase (ALT) ≤ 2.5×ULN (Patients with liver metastases: ≤ 5×ULN)
- Aspartate Aminotransferase (AST) ≤ 2.5×ULN (Patients with liver metastases: ≤ 5×ULN)
- Albumin (ALB) ≥ 30 g/L Renal Function
- Creatinine (Cr) ≤ 1.5×ULN
- Creatinine Clearance (Ccr)
- (Calculated only when creatinine > 1.5×ULN) Endogenous creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula) Cardiac Function
- 12-lead electrocardiogram No severe arrhythmias, and a mean Fridericia-corrected QT interval (QTc) of <450 ms (males) or <470 ms (females)
- Echocardiogram Left ventricular ejection fraction (LVEF) ≥ 50%
- Agree to cooperate in completing daily nausea and vomiting logs and scale assessments;
- Understand the nature of this study; the patient and/or legal guardian voluntarily agree to participate in this trial and sign the informed consent form.
Exclusion Criteria:
- 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;
- Initiation of potent opioid analgesics within 48 hours prior to enrollment (adjustment of the dose of medications already in use is permitted);
- Presence of conditions affecting the assessment of vomiting, such as gastrointestinal obstruction, gastroparesis, or intestinal obstruction;
- Patients who are difficult to enroll due to clinically diagnosed psychiatric disorders;
- Localized or active systemic infections requiring treatment;
- Pregnant or breastfeeding women, as well as patients of childbearing age who refuse to use appropriate contraceptive measures during the course of this trial;
- Patients who have participated in other clinical trials within 30 days prior to the first dose of the study drug (patients who failed screening for other clinical trials may be enrolled in this study);
- Patients with other factors deemed by the investigator to be unsuitable for participation in this study, such as any physiological or psychological conditions that may increase study risks, affect patient adherence to the protocol, or interfere with the patient's ability to complete the trial.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Antiemetic Prophylaxis
All subjects who meet the inclusion criteria will receive prophylactic antiemetic treatment with Fosrolapitant and Palonosetron Hydrochloride to receiving an infusion of Trastuzumab Rezetecan.
During follow-up, investigators will collect data on nausea, vomiting, use of rescue medication, and adverse events to evaluate the efficacy and safety of this hormone-free antiemetic regimen.
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D1: Fosrolapitant and Palonosetron Hydrochloride for Injection (218 mg of pholorapitant and 0.25 mg of palonosetron hydrochloride), IV, administered 1 hour before 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Overall Complete Response (CR) Rate
Tidsramme: 0 to 120 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
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The proportion of participants without any vomiting episodes and without receiving rescue antiemetic medication during the overall 0-120 hour period after trastuzumab rezetecan infusion.
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0 to 120 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Complete Response (CR) Rate in Acute Phase (0-24 h)
Tidsramme: 0 to 24 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
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Percentage of participants with no vomiting and no rescue antiemetics within 0-24 hours post trastuzumab rezetecan
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0 to 24 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
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Complete Response (CR) Rate in Delayed Phase (24-120 h)
Tidsramme: 24 to 120 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
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Percentage of participants with no vomiting and no rescue antiemetics within 24-120 hours post trastuzumab rezetecan
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24 to 120 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
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Complete Response (CR) Rate in Very Delayed Phase (120-168 h)
Tidsramme: 120 to 168 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
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Percentage of participants with no vomiting and no rescue antiemetics within 120-168 hours post trastuzumab rezetecan
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120 to 168 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
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Complete Protection (CP) Rate
Tidsramme: 0 to 168 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
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Proportion of participants without vomiting, no rescue medication, and maximum VAS nausea score <25 mm during observation period
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0 to 168 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
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Complete Control (TC) Rate
Tidsramme: 0 to 168 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
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Proportion of participants without vomiting, no rescue medication, and maximum VAS nausea score <5 mm during observation period
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0 to 168 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
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No Nausea Rate & No Vomiting Rate & No Rescue Medication Rate
Tidsramme: 0 to 168 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
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No nausea rate: participants with maximum VAS nausea score <5 mm; No vomiting rate: participants with zero vomiting episodes (rescue use allowed); No rescue medication rate: participants who never use rescue antiemetics
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0 to 168 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
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Rate of Trastuzumab Rezetecan Dose Delay or Reduction Due to Nausea and Vomiting
Tidsramme: ntire duration of Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
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Percentage of subjects whose trastuzumab rezetecan dose is delayed or reduced caused by treatment-induced nausea and vomiting
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ntire duration of Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
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Safety Endpoints (Adverse Events, Serious Adverse Events)
Tidsramme: From informed consent signing to 30 days after last study drug administration
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Incidence, severity (graded per CTCAE v5.0) and relatedness of all adverse events (AEs), treatment-related AEs, ≥3 grade AEs and serious adverse events (SAEs); changes in vital signs and laboratory parameters
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From informed consent signing to 30 days after last study drug administration
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Tegn og symptomer, fordøjelsessystemet
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Opkastning
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ring
- Terapeutik
- Lægemiddeladministrationsruter
- Lægemiddelterapi
- Heterocykliske forbindelser, bro-ring
- Isoquinoliner
- Quinuclidiner
- Palonosetron
- Injektioner
Andre undersøgelses-id-numre
- CINV-2026-001
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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