臨床研究等提出・公開システム

MD-110 Phase 3 Study

MD-110 Phase 3 Study

101

The patients were all Asian females. The mean age (SD) was 51.9 (10.5) years. ECOG performance status were zero in all patients. 1.0% (1/101) of patients received neoadjuvant chemotherapy. 5.0% (5/101) of patients had previous radiotherapy.

101 patients were received the study drug. Regarding cancer chemotherapy, of the 93 patients who completed all 4 cycles, 92.5% (86/93) of patients received TC chemotherapy at the standard dose. The percentage of patients whose TC chemotherapy dose was reduced by 20% in cycles 2, 3, and 4 were 5.1% (5/99), 6.1% (6/98), and 7.5% (7/93), respectively. Eight patients withdrew from the study after administering the study drug. The main reasons for discontinuation were "concomitant theapy violation" (4 patients) and "adverse events" (3 patients).

There were no AEs leading to death. Serious AEs (SAEs) occurred in six patients, including urticaria, decreased performance status, diverticulitis, pneumonia, rash, and malaise (one SAE per patient). Among these SAEs, urticaria was the only SAE related to the study drug. However, it did not lead to study withdrawal and recovered with antihistamine treatment and was considered to be caused by the combination of TC chemotherapy and the study drug. Three patients withdrew from the study due to pneumonia, decreased appetite, and urticaria (one AE per patient). Study drug-related AEs of grade 3 or higher were urticaria in two patients and increased alanine aminotransferase in one patient. One case of urticaria was a study drug-related SAE. The remaining two cases were nonserious, did not lead to study withdrawal, and recovered with drug treatment.

The mean (SD) duration of severe neutropenia for MD-110, the primary endpoint, was 0.2 (0.4) days. The upper limit of the two-sided 95% confidence interval for the mean duration of severe neutropenia was 0.2days, below the predefined threshold of 3.0days.

The incidence of febrile neutropenia, the secondary efficacy endpoint, was 6.9% (7/101).

MD-110 was effective against chemotherapy-induced neutropenia. No additional safety concern, compared with the originator, was observed in patients with breast cancer receiving TC chemotherapy.

Oct. 12, 2023

https://pubmed.ncbi.nlm.nih.gov/37824431/

No

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Mochida Pharmaceutical Co., Ltd.

7, Yotsuya 1-chome, Shinjuku-ku, Tokyo 160-8515, Japan

clinical.trials.contact@mochida.co.jp

Mochida Pharmaceutical Co., Ltd.

7, Yotsuya 1-chome, Shinjuku-ku, Tokyo 160-8515, Japan

+81-3-3225-6303

webmaster@mochida.co.jp

completed

May. 01, 2020

Interventional

Multi-center, open-label, non-comparative study

treatment purpose

3

Diagnosed with primary invasive breast cancer, etc.

Double cancer, etc.

Female

Chemotherapy-induced febrile neutropenia

investigational material(s)
Generic name etc : MD-110
INN of investigational material : -
Therapeutic category code : 339 Other agents relating to blood and body fluides
Dosage and Administration for Investigational material : Subcutaneous injection

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

safety
efficacy
Efficacy: The duration of severe neutropenia (DSN)
Safety: Adverse Reactions

efficacy
The rate of febrile neutropenia (FN)

Mar. 24, 2020