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Fosrolapitant and Palonosetron for the Prevention of Antibody-drug Conjugate-induced Nausea and Vomiting

ConditionNausea and Vomiting Induced by Antibody-drug Conjugates (ADCs)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University Cancer Hospital & Institute

About this trial

This study is aimed to evaluate the efficacy and safety of Fosrolapitant and Palonosetron for Antibody-drug conjugate-induced nausea and vomiting

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

18 years of age or older, of either gender

Has a diagnosed malignant tumor

has never been treated with ADCs and is to receive the first course of ADCs

Predicted life expectancy of ≥ 3 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fosrolapitant and Palonosetron for injection

    Drug

    • Experimental: Drug：Fosrolapitant and Palonosetron for injection Drug：Dexamethasone Drug: placebo • Active Comparator: Drug：HR20013 placebo Drug: fosaprepitant dimeglumine for injection Drug：Palonosetron injection Drug: Dexamethasone

Treatment groups

124 Participants
are divided into 2 treatment groups
Group A: Fosrolapitant and Palonosetron + dexamethasone + placeboExperimental treatment 1 intervention
Group B: fosaprepitant dimeglumine for injection+palonosetron hydrochloride injection+dexamethasoneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Complete response rate

Time frame
Within 14 days after ADC administration

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Peking University Cancer Hospital & Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: