臨床研究等提出・公開システム

A randomized, double-blind, multicenter, phase III study of Pro-NETU for the prevention of chemotherapy induced nausea and vomiting (CINV) in patients receiving AC/EC based highly emetogenic chemotherapy

A randomized, double-blind, multicenter, phase III study of Pro-NETU for the prevention of chemotherapy induced nausea and vomiting (CINV) in patients receiving AC/EC based highly emetogenic chemotherapy

102

The patients who are receiving doxorubicin-cyclophosphamide or epirubicin-cyclophosphamide (AC/EC) chemotherapy were randomized to Fosnetupitant (FosNTP) 235 mg group or Fosaprepitant (FosAPR) 150 mg group both in combination with intravenous palonosetron (PALO) 0.75 mg and dexamethasone (DEX) 9.9 mg.

A total of 102 patients was randomized. Of these, 52 patients were assigned to the FosNTP group and 50 to the FosAPR group, and all patients received the study drug.

In the FosNTP group, treatment-related adverse events (TRAEs) (>= 5%) were headache, diarrhea, urticaria, malaise, and decreased appetite (5.8%). In the FosAPR group, TRAEs (>= 5%) were constipation (6.0%) and injection site pain (8.0%). TRAEs relevant to injection site reactions (ISRs) were observed in 0% in the FosNTP group and 10.0% in the FosAPR group.

The incidence of TRAEs (Primary endpoint) was 21.2% (11/52 patients; 95% CI, 11.1%-34.7%) in the FosNTP group compared with 22.0% (11/50 patients; 95% CI, 11.5% 36.0%) in the FosAPR group.

The overall (0-120 h) complete response (CR; no emetic event and no rescue medication) rate was 45.9% (23/51 patients; 95% CI, 33.2%-58.6%) in the FosNTP group and 51.3% (25/49 patients; 95% CI, 37.3%-65.2%) in the FosAPR group.

FosNTP administered as a single intravenous dose in combination with PALO and DEX showed a good safety profile in patients receiving AC/EC.

Jan. 20, 2022

https://acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.34088

Yes

Taiho Group (Taiho) provides a platform for accepting researchers requests for sharing anonymized, patient-level, analyzable datasets from articles published in peer-reviewed journals about the primary results from Taiho-sponsored interventional clinical trials in patients in which the medicine and the indication has received marketing approval from regulatory authorities in the United States, the European Union, and/or Japan on or after January 15, 2018. Access to the clinical trial data is contingent upon approval of a proposed study protocol by an independent review panel and the execution of a data-sharing agreement with the researcher. See: https://www.taiho.co.jp/en/science/policy/clinical_trial_information_disclosure_policy/index.html

https://www.clinicaltrials.jp/file/UKYLPuFgd

Taiho Pharmaceutical Co., Ltd.

-

toiawaseCD1@taiho.co.jp

Taiho Pharmaceutical Co., Ltd.

-

-

toiawase@taiho.co.jp

completed

April. 18, 2019

Interventional

Central registration, double-blind, randomized, parallel-group, multicenter study

prevention purpose

3

1. Patients who have provided written informed consent
2. Patients who are scheduled to be received cancer chemotherapy including the HEC agents (AC/EC)
3. ECOG performance status score of 0 to 1

1. Patients with infection, diabetes mellitus, or other disease with difficultly to administer of dexamethasone, which is defined in the protocol
2. Patients who are unable or unwilling to cooperate in the implementation of study procedures (eg; writing a study report)

Both

Chemotherapy-induced nausea and vomiting

investigational material(s)
Generic name etc : Pro-NETU
INN of investigational material : fosnetupitant
Therapeutic category code : 239 Other agents affecting digestive organs
Dosage and Administration for Investigational material : Pro-NETU 235 mg should be intravenously administered with drip infusion before the start of administration of highly emetogenic chemotherapy (HEC).

control material(s)
Generic name etc : Fosaprepitant
INN of investigational material : Fosaprepitant
Therapeutic category code : 239 Other agents affecting digestive organs
Dosage and Administration for Investigational material : Fosaprepitant 150 mg should be intravenously administered with drip infusion before the start of administration of HEC.

safety
The incidence of side effect

safety
efficacy
Efficacy, Safety

+81-3-3784-8305

Mar. 20, 2019