臨床研究等提出・公開システム

A phase II study of Pro-NETU in patients receiving highly emetogenic chemotherapy (HEC)

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594

The patients who are receiving cisplatin-based chemotherapy were randomized to placebo group or FosNTP 81 mg group or FosNTP 235 mg group both in combination with palonosetron (PALO) 0.75 mg and dexamethasone (DEX).

A total of 594 patients was randomized. Seven patients did not receive the study drug.

The incident rate of adverse events (AEs) and treatment-related AEs were similar between the 3 groups. There was no tendency noted for the rates of AEs to increase in a dose-dependent manner. Treatment-related AEs (>=5%) were constipation (13.8%, 14.2%, and 16.4%, respectively, in the placebo and FosNTP 81 mg and 235 mg groups) and hiccups (4.6%, 7.1%, and 5.6%, respectively, in the placebo and FosNTP 81 mg and 235 mg groups). Injection site reactions (ISRs)-related AEs were all grade 1 or 2, there was no tendency noted for the rate to increase in a dose-dependent manner (5.7%, 10.8%, and 7.9%, respectively, in the placebo and FosNTP 81 mg and 235 mg groups).

The overall (0-120 h) complete response (CR; no emetic event and no rescue medication) rates were 54.7%, 63.8%, and 76.8%, respectively, in the placebo, FosNTP 81 mg, and 235-mg groups. The overall CR rate in the FosNTP 235 mg group was statistically superior to that in the placebo group (adjusted difference, 22.0%; 97.5% CI, 11.7% to 32.3% [P < .001; 2-sided significance level = .025]). There was not a statistically significant difference noted between the FosNTP 81 mg and placebo groups (adjusted difference, 9.1%; 95% CI, -0.4% to 18.6% [P = .061; 2-sided significance level = .05]).

The rates of all secondary efficacy endpoints were higher in the FosNTP 235 mg group compared with the placebo group.

FosNTP 235 mg group showed superior prevention of chemotherapy-induced nausea and vomiting among patients receiving cisplatin-based chemotherapy compared with the placebo group, and with a satisfactory safety profile.

Mar. 28, 2022

https://acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.32429

No

Data will not be shared according to the Sponsor policy on data sharing. Taiho policy on data sharing may be found at https://www.taiho.co.jp/en/science/policy/clinical_trial_information_disclosure_policy/index.html.

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

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

Sept. 05, 2016

Interventional

Central registration, multicenter, double-blind, placebo-controlled, randomized, parallel-group, comparative study

prevention purpose

2

- Patients who are scheduled to receive cancer chemotherapy including the HEC agents
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 1
- Patients who have provided written informed consent

- Patients with infection, diabetes mellitus, or other disease to whom it difficult to administer of DEX, which is defined in the protocol
- Patients who are unable or unwilling to cooperate in the implementation of study procedures

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 (either 90 mg, 260 mg or Placebo) should be intravenously administered to each subject before the start of administration of HEC.

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

efficacy
CR rate during the first 120 hours after the start of administration of an HEC

safety
efficacy
pharmacokinetics
- Efficacy
- Safety
- Pharmacokinetics

+81-11-706-7061

Aug. 30, 2016