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

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

795

The patients who are receiving cisplatin-based chemotherapy were randomized 1:1 to FosNTP 235 mg group or FosAPR 150 mg group both in combination with palonosetron (PALO) 0.75 mg and dexamethasone (DEX).

A total of 795 patients was randomized in the single chemotherapy cycle (S-cycle), of whom 785 received the study drugs (FosNTP or FosAPR). A total of 129 patients was enrolled in the multiple chemotherapy cycles (M-cycles), of whom 126 received FosNTP.

In the S-cycle, treatment-related adverse events (TRAEs) (>= 5%) in either group (FosNTP vs. FosAPR) were constipation (11.2% vs. 13.7%, respectively) and hiccups (4.8% vs. 7.1%, respectively). The proportions of patients who developed TRAEs relevant to injection site reactions (ISRs) were significantly lower with FosNTP vs. FosAPR- 0.3% vs. 3.6% (P < .001), respectively.

In the S-cycle, the overall (0-120 h) complete response (CR; no emetic event and no rescue medication) rate was 75.2% vs. 71.0% with FosNTP vs. FosAPR, respectively. The intergroup difference in the overall CR rate was 4.1% (95% CI, -2.1% to 10.3%), which demonstrated the noninferiority of FosNTP to FosAPR.

The efficacy assessment was continued until 168 h, indicating that all efficacy parameters tended to be higher with FosNTP than with FosAPR in the delayed (24-120 h) and overall phases and in the observational period including 168 h.

The noninferiority of FosNTP to FosAPR was demonstrated in the overall CR rate in patients receiving highly emetogenic chemotherapy (HEC) in combination with PALO and DEX.

Nov. 18, 2021

https://ascopubs.org/doi/10.1200/JCO.21.01315

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/HXGBGuFgd

Taiho Pharmaceutical Co., Ltd.

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toiawaseCD1@taiho.co.jp

Taiho Pharmaceutical Co., Ltd.

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toiawase@taiho.co.jp

completed

Feb. 18, 2019

Interventional

Single-dose part: Central registration, double-blind, randomized, parallel-group, multicenter study Repeated-dose part: Open-label, uncontrolled 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 (cisplatin)
3. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 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 : (Only single-dose part) Fosaprepitant 150 mg should be intravenously administered with drip infusion before the start of administration of HEC.

safety
efficacy
Single-dose part: The CR rate during overall period
Repeated-dose part: The incidence rate of AEs and side effects

safety
efficacy
Efficacy
Safety

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Jan. 09, 2019