臨床研究等提出・公開システム

AN OPEN-LABEL, MULTI-CENTER, EXPANDED ACCESS STUDY OF TRASTUZUMAB DERUXTECAN IN JAPANESE SUBJECTS WITH HER2-POSITIVE ADVANCED GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA

AN OPEN-LABEL, MULTI-CENTER, EXPANDED ACCESS STUDY OF TRASTUZUMAB DERUXTECAN IN JAPANESE SUBJECTS WITH HER2-POSITIVE ADVANCED GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA

64

Sixty-four subjects who were enrolled and received at least one dose of the study drug were included in the safety analysis set. The average age (range) of the safety analysis set was 64.4 (37 to 84) years, and the majority of subjects were male (50 subjects [78.1%]). Fifty-two subjects had gastric adenocarcinoma and 12 subjects had gastroesophageal junction (GEJ) adenocarcinoma. All subjects had received 2 or more prior regimens, and the median was 4.0 (2 to 11). The most common prior regimens included paclitaxel combined with ramucirumab (28 subjects [43.8%]), SOX therapy (tegafur/gimeracil/oteracil + oxaliplatin) combined with trastuzumab (23 subjects [35.9%]), XP therapy (capecitabine + cisplatin) combined with trastuzumab (16 subjects [25.0%]), and XELOX therapy (capecitabine + oxaliplatin) combined with trastuzumab (13 subjects [20.3%]).

Planned enrolled subjects: approximately 100; enrolled subjects: 64; dosed subjects: 64 The reasons for withdrawal were completion of the study in 40 subjects, disease progression per the Response Evaluation Criteria in Solid Tumors (RECIST) ver. 1.1 in 15 subjects, clinical progression in 4 subjects, adverse events in 3 subjects, and death in 2 subjects. The median (range) of study treatment duration was 2.7 (0.7 to 6.2) months and the median (range) of dose number was 3.0 (1 to 9) at the completion of the study.

Among 64 subjects who were included in the safety analysis set, serious adverse events (SAEs) occurred in 17 subjects (26.6%); and in 10 subjects (15.6%) of SAEs, were judged to be related to the study drug. Serious adverse events included febrile neutropenia (6 subjects [9.4%]) and disease progression (5 subjects [7.8%]). All events of serious febrile neutropenia were judged to be related to the study drug. Fatal adverse events occurred in 6 subjects (9.4%). Five of these events occurred due to disease progression, and were judged to be unrelated to the study drug. The cause of death in the 6th subject was due to septicemia and febrile neutropenia which were judged to be related to the study drug. Adverse events leading to study discontinuation occurred in 4 subjects (6.3%). These events included pneumonitis in 2 subjects, disease progression in 1 subject, and sepsis and febrile neutropenia in 1 subject. With the exception of disease progression, all adverse events leading to study discontinuation were judged to be related to the study drug. Potential interstitial lung disease (ILD)/pneumonitis events included ILD in 2 subjects (3.1%) and pneumonitis in 2 subjects (3.1%). Among these 4 subjects, 3 subjects (4.7%) were adjudicated as ILD by the external review board, and these events were judged related to the study drug by investigator. One subject each experienced 1 event of Grade 1, 2 or 3 in severity, respectively. No events of Grade 4 or higher in severity were reported.

The primary endpoint of this study is safety and please refer to "Adverse Events" section.

Not setting in this study.

This study was aimed to provide trastuzumab deruxtecan to patients with This study was aimed to provide trastuzumab deruxtecan to patients with HER2-positive advanced gastric adenocarcinoma or GEJ adenocarcinoma. The collected adverse events and their severity were generally consistent with previous results in other clinical studies in trastuzumab deruxtecan, and no new safety issues were identified.

No

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

DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial@daiichisankyo.co.jp

DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial@daiichisankyo.co.jp

completed

April. 01, 2020

Interventional

An open-label, multi-center, expanded access study

treatment purpose

N/A

1. Has a pathologically documented locally advanced or metastatic adenocarcinoma of gastric or gastroesophageal junction with HER2 positive
2. Has a medical history of at least 2 prior regimens which had to include fluoropyrimidine agent, platinum agent, and trastuzumab
3. Has an ECOG PS of 0 to 1

1. Has a medical history of clinically significant lung disease
2. Has active central nervous system metastases
3. Has had non-gastric or gastroesophageal junction primary malignancies within 3 years

Both

HER2-positive locally advanced or metastatic gastric or
gastroesophageal junction adenocarcinoma

investigational material(s)
Generic name etc : Trastuzumab deruxtecan
INN of investigational material : Trastuzumab deruxtecan
Therapeutic category code : 42- Antineoplastic agents
Dosage and Administration for Investigational material : Intravenous (Once every 3 weeks, 6.4mg/kg)

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

safety
Adverse Event

-

Mar. 10, 2020