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Fosrolapitant Combined With Palonosetron to Prevent Trastuzumab Rezetecan Related CINV

ConditionChemotherapy-Induced Nausea and Vomiting (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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Fosrolapitant and Palonosetron Hydrochloride for Injection

    Drug

    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.

Treatment groups

56 Participants
are divided into 1 treatment group
Group A: Antiemetic ProphylaxisExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall Complete Response (CR) Rate

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.

Time frame
0 to 120 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)

Secondary outcomes

1

Complete Response (CR) Rate in Acute Phase (0-24 h)

Percentage of participants with no vomiting and no rescue antiemetics within 0-24 hours post trastuzumab rezetecan

Time frame
0 to 24 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
2

Complete Response (CR) Rate in Delayed Phase (24-120 h)

Percentage of participants with no vomiting and no rescue antiemetics within 24-120 hours post trastuzumab rezetecan

Time frame
24 to 120 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
3

Complete Response (CR) Rate in Very Delayed Phase (120-168 h)

Percentage of participants with no vomiting and no rescue antiemetics within 120-168 hours post trastuzumab rezetecan

Time frame
120 to 168 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
4

Complete Protection (CP) Rate

Proportion of participants without vomiting, no rescue medication, and maximum VAS nausea score \<25 mm during observation period

Time frame
0 to 168 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tianjin Medical University Cancer Institute and Hospital

Lead sponsor

Source ClinicalTrials.gov
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