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Tests treatment safety and results for Chemotherapy-induced Nausea and Vomiting
Official title An Exploratory Study on Efficacy and Safety of Fosaprepitant and Palonosetron Hydrochloride for Injection in Preventing CINV From Multi-Agent HEC
ClinicalTrials.gov ID: NCT07482891
What this study is testing
What is Fosrolapitant and Palonosetron Hydrochloride for Injection?
Fosrolapitant and Palonosetron Hydrochloride for Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for chemotherapy-induced nausea and vomiting.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This prospective, multicenter, non-comparative, open-label trial design aims to evaluate the efficacy and safety of Fosrolapitant and Palonosetron Hydrochloride for Injection in preventing nausea and vomiting induced by hyperemetic chemotherapy (HEC) over multiple days. Eligible subjects were screened and assigned to Arm 1 or Arm 2 according to medical protocol.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Aged 18-75 years, any gender, voluntarily signed informed consent form (ICF), with good compliance;
- Histologically or cytologically confirmed malignant solid tumour;
- No prior exposure to any chemotherapeutic agents;
- First-time participants with malignant solid tumours scheduled to receive a treatment regimen based on multi-day HEC chemotherapy (HEC refers to the...
- No impairment in speech, hearing, or comprehension;
You likely can't join if
- people with symptomatic brain metastases or any symptoms suggestive of brain metastases or intracranial hypertension;
- people who have received radiotherapy within 7 days prior to enrolment, extensive radiotherapy (e.g., whole-chest or whole-abdomen radiotherapy)...
- Administration within 2 days prior to enrolment of medications with potential antiemetic effects: first-generation 5-HT3 receptor antagonists (e.g...
- Initiation of benzodiazepine or opioid therapy within 2 days prior to enrolment (excluding zolpidem, temazepam, or midazolam administered alone...
- people who commenced morphine use within 7 days prior to enrolment (excluding those on stable doses);
- Systemic corticosteroid therapy (including but not limited to dexamethasone, hydrocortisone, methylprednisolone, or prednisolone) or sedating...
See the full eligibility criteria
- Aged 18-75 years, any gender, voluntarily signed informed consent form (ICF), with good compliance;
- Histologically or cytologically confirmed malignant solid tumour;
- No prior exposure to any chemotherapeutic agents;
- First-time participants with malignant solid tumours scheduled to receive a treatment regimen based on multi-day HEC chemotherapy (HEC refers to the risk of anti-tumour drug-induced nausea and vomiting as defined in the...
- No impairment in speech, hearing, or comprehension;
- Expected survival ≥ 3 months;
- ECOG : 0-1;
- Organ function must be adequate and meet the following criteria:
- Neutrophil count ≥ 1.5 × 10⁹/L;
- Haemoglobin ≥ 90 g/L;
- Platelet count ≥ 100 × 10⁹/L;
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN);
- In patients without known liver metastases, aspartate aminotransferase ≤ 2.5 × ULN and/or alanine aminotransferase ≤ 2.5 × ULN (for patients with liver metastases, may be relaxed to ≤ 5 × ULN);
- Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 ml/min;
- Electrocardiogram: QTc ≤ 450 ms (males), QTc ≤ 470 ms (females);
- Echocardiogram: LVEF (left ventricular ejection fraction) ≥ 50%.
- Female people of childbearing potential, and male people with female partners of childbearing potential, must use one form of effective contraception from the time of signing the informed consent form until 6 months...
- people with symptomatic brain metastases or any symptoms suggestive of brain metastases or intracranial hypertension;
- people who have received radiotherapy within 7 days prior to enrolment, extensive radiotherapy (e.g., whole-chest or whole-abdomen radiotherapy) within 3 months prior to enrolment, local palliative radiotherapy (e.g...
- Administration within 2 days prior to enrolment of medications with potential antiemetic effects: first-generation 5-HT3 receptor antagonists (e.g., ondansetron), phenothiazines (e.g., prochlorperazine), butyrophenones...
- Initiation of benzodiazepine or opioid therapy within 2 days prior to enrolment (excluding zolpidem, temazepam, or midazolam administered alone daily);
- people who commenced morphine use within 7 days prior to enrolment (excluding those on stable doses);
- Systemic corticosteroid therapy (including but not limited to dexamethasone, hydrocortisone, methylprednisolone, or prednisolone) or sedating antihistamines (e.g., diphenhydramine) administered within 7 days prior to...
- Use of palonosetron within 14 days prior to enrolment;
- Use of NK-1 receptor antagonists within 28 days prior to enrolment;
- Vomiting and/or retching, nausea occurring within 24 hours prior to enrolment;
- Presence of poorly controlled serosal effusions, including pleural effusion, ascites, pericardial effusion (exclusion may be waived if controlled by treatment and stable for ≥2 weeks);
- Severe cardiovascular disease within 3 months prior to enrolment, including but not limited to acute myocardial infarction, unstable angina pectoris, significant valvular or pericardial disease, history of ventricular...
- Concurrent active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10⁴ copies/mL), active hepatitis C (HCV-Ab positive with HCV-RNA ≥ ULN), known acquired immunodeficiency syndrome (AIDS) or HIV-positive status, or...
- Concurrent conditions precluding dexamethasone administration, such as active infections (e.g., pneumonia) or uncontrolled conditions (e.g., diabetic ketoacidosis, intestinal obstruction);
- Known contraindications and/or allergies to study medications;
- Participation in another clinical trial within 30 days prior to enrolment (as determined by the use of study medication);
- people deemed by the investigator to have other conditions rendering them unsuitable for this study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.