Foslorapitant with Palonosetron to Help Prevent Nausea and Vomiting from Trastuzumab Rezetecan

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, multicenter Phase 2 trial designed to explore the safety and potential efficacy of a prophylactic antiemetic combination for patients treated with Trastuzumab Rezetecan. Participants receive foslorapitant and palonosetron intravenously one hour before each cycle of treatment, with monitoring of daily vomiting frequency and nausea severity over two treatment cycles. The study includes screening, treatment, and follow-up phases to assess tolerability and preliminary effectiveness in preventing CINV. Eligibility requires adults with good organ function and adequate performance status who are scheduled for Trastuzumab Rezetecan and meet specific health criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Sign a written informed consent form and voluntarily enroll in this study;
2. Be at least 18 years of age; gender is not a restriction;
3. Be a patient scheduled to receive treatment with Trastuzumab Rezetecan;
4. Have an ECOG performance status score of 0-2;
5. No ascites or pleural effusion requiring drainage;
6. No gastrointestinal obstruction, such as pyloric stenosis or intestinal obstruction;
7. Expected survival of ≥12 weeks;
8. 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%
9. Agree to cooperate in completing daily nausea and vomiting logs and scale assessments;
10. 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:

1. Allergy to the study drug or its excipients;
2. Known contraindications to NK-1 receptor antagonists, 5-HT3 receptor antagonists, or dexamethasone;
3. Nausea or vomiting at the time of enrollment requiring treatment with antiemetics;
4. Use of medications with antiemetic effects within 2 days prior to the first dose;
5. Initiation of potent opioid analgesics within 48 hours prior to enrollment (adjustment of the dose of medications already in use is permitted);
6. Presence of conditions affecting the assessment of vomiting, such as gastrointestinal obstruction, gastroparesis, or intestinal obstruction;
7. Patients who are difficult to enroll due to clinically diagnosed psychiatric disorders;
8. Localized or active systemic infections requiring treatment;
9. Pregnant or breastfeeding women, as well as patients of childbearing age who refuse to use appropriate contraceptive measures during the course of this trial;
10. 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);
11. 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.

Where it's running

• Tianjin Cancer Hospital Airport Hospital
  Tianjin, China Recruiting

Study contacts

• Study coordinator: Zhansheng Jiang Tianjin Cancer Hospital Airport Hospital
• Email: zhjiang@tmu.edu.cn
• Phone: 022-23340123

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Neoadjuvant trastuzumab, durvalumab, and FLOT for HER2-positive gastric or GEJ cancer

  This study tests a pre-surgery treatment combining trastuzumab, durvalumab, and FLOT for patients with HER2-positive locally advanced gastric or gastroesophageal junction cancer to see how many achieve complete tumor disappearance.

  Recruiting Phase 2 Samsung Medical Center · Seoul, Gang-Nam · NCT07911280

• HR20013 for preventing nausea and vomiting in cancer patients receiving chemotherapy

  This real-world study tests whether HR20013 helps prevent nausea and vomiting in adults with cancer who are getting chemotherapy.

  Recruiting Sun Yat-sen University · Guangzhou, Guangdong · NCT07874308

• See how nasal ondansetron compares to IV in healthy adults

  This study tests whether a nasal spray form of ondansetron delivers similar blood levels as the IV version in healthy adults.

  Recruiting Phase 1 Nasus Pharma · Jerusalem · NCT07868861

• Neoadjuvant Pyrotinib-to-pertuzumab for HER2-positive early breast cancer

  This trial tests whether a two-step neoadjuvant plan with Pyrotinib plus Trastuzumab and Docetaxel followed by Pertuzumab plus Trastuzumab and Docetaxel works better than four cycles of Pertuzumab plus Trastuzumab and Docetaxel in women with HER2-positive early- to locally advanced breast cancer.

  Recruiting Phase 3 Shanghai Jiao Tong University School of Medicine · Shanghai · NCT07797218

• Trastuzumab Rezetecan and Gemcitabine before surgery for HER2-positive UTUC

  This study tests whether giving trastuzumab deruxtecan with gemcitabine before and around surgery can improve outcomes for people with HER2-positive upper tract urothelial cancer.

  Recruiting at 10 sites Phase 2 Tongji Hospital · Huanggang, Hubei and 9 other locations · NCT07741448

• Auricular point stimulation with dexamethasone versus standard antiemetics for nausea from trastuzumab deruxtecan

  This trial tests whether adding ear acupuncture-style stimulation to dexamethasone can prevent and reduce nausea and vomiting caused by trastuzumab deruxtecan in breast cancer patients, compared with the usual antiemetic regimen.

  Recruiting Phase 3 Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou · NCT07716189

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.