Evidence map›Paper›PMID 40866861›Full record

ArticleBMC medicine2025

Pharmacokinetics, safety, and efficacy of mixed formulation of fosrolapitant and palonosetron (HR20013) in combination with dexamethasone in patients with solid tumors scheduled for highly emetogenic cisplatin-based chemotherapy: a phase I trial.

Yuanyuan Zhao, Yuxiang Ma, Tengrui Yin, Zhiquan Qin, Linlin Liu, Guoqiang Kong, Ranran Zhang, Yuanyuan Huang, Li Zhang, Hongyun Zhao

Registry-linked trialAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05465681 (A Phase I Clinical Study of Safety and Pharmacokinetics of Single-dose HR20013 for Injection Combined With Dexamethasone in Patients With Malignant Solid Tumors Receiving Cisplatin-based Chemotherapy), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05465681 phase1completednot on this map

A Phase I Clinical Study of Safety and Pharmacokinetics of Single-dose HR20013 for Injection Combined With Dexamethasone in Patients With Malignant Solid Tumors Receiving Cisplatin-based Chemotherapy

TypeinterventionalSponsorFujian Shengdi Pharmaceutical Co., Ltd.Ran2022 to 2023Enrolled24ConditionsPrevention of Nausea and Vomiting Caused by Highly Emetogenic ChemotherapyArmsHR20013 for injection；dexamethason
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Yuanyuan Zhao *Department of Medical oncology, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, 510060, China.
Yuxiang Ma *Department of Clinical Research, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-Sen University Cancer Center, Guangzhou, 510060, China.
Tengrui Yin *Department of Clinical Pharmacology, Fujian Shengdi Pharmaceutical Co., Ltd., Shanghai, 200000, China.
Zhiquan QinDepartment of Medical Oncology, Zhejiang Provincial People's Hospital (Affiliated People's Hospital, Hangzhou Medical College), Hangzhou, 310000, China.
Linlin LiuPhase I Clinical Laboratory, China-Japan Union Hospital of Jilin University, Changchun, 130000, China.
Guoqiang KongDepartment of Surgery, The First Affiliated Hospital and Clinical Medical College of Henan University of Science and Technology, Luoyang, 471003, China.
Ranran ZhangDepartment of Clinical Pharmacology, Fujian Shengdi Pharmaceutical Co., Ltd., Shanghai, 200000, China.
Yuanyuan HuangDepartment of Clinical Pharmacology, Fujian Shengdi Pharmaceutical Co., Ltd., Shanghai, 200000, China.
Li ZhangDepartment of Medical oncology, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, 510060, China. zhangli@sysucc.org.cn.
Hongyun ZhaoDepartment of Clinical Research, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-Sen University Cancer Center, Guangzhou, 510060, China. zhaohy@sysucc.org.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis phase I trial aimed to assess the pharmacokinetics (PK), safety, and preliminary efficacy of a single dose of HR20013 (mixed formulation of fosrolapitant and palonosetron) plus dexamethasone in patients with malignant solid tumors.

methodsSolid tumor patients who were naive to cisplatin-based chemotherapy and scheduled to receive the single-day cisplatin-based chemotherapy were enrolled. Patients would receive a single intravenous infusion of HR20013 (Day 1) before cisplatin-based chemotherapy, alongside oral dexamethasone (Day 1, 12 mg, once a day; Day 2-4, 3.75 mg, twice a day). Primary endpoints were PK parameters of fosrolapitant, rolapitant, M19 (a major active metabolite of rolapitant), palonosetron, and dexamethasone.

resultsTwenty-four patients were enrolled, and 22 received study treatment. Fosrolapitant reached maximum plasma concentration (C

conclusionsHR20013 plus dexamethasone had a favorable PK profile, manageable safety, and durable antiemetic efficacy.

trial registrationClinicalTrials.gov, NCT05465681.

Indexed as

AntiemeticsCisplatinDexamethasoneIsoquinolinesNeoplasmsPyrrolesQuinuclidinesAdultAgedAntineoplastic AgentsFemaleHumansMaleMiddle AgedMorpholinesNauseaAntiemeticsAntineoplastic AgentsCisplatinDexamethasonefosaprepitantIsoquinolinesMorpholinesPalonosetronPyrrolesQuinuclidinesAntiemeticDexamethasoneHR20013Mixed formulationPharmacokinetics

Identifiers

PMID40866861
PMCPMC12392532

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.