Phase II clinical trial evaluating the safety and efficacy of trastuzumab emtansine in patients with advanced HER2-positive extramammary Paget's disease (TEMENOS 2 trial) - TEMENOS2

Funakoshi Takeru0 sites14 target enrollmentNovember 21, 2021

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: HER2-positive advanced paget disease affecting scrotum and Penis
Sponsor: Funakoshi Takeru
Enrollment: 14
Status: Recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

November 21, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Funakoshi Takeru

•(1\) Patients who have received sufficient explanation about the content of the trial and have obtained written consent.
•(2\) Patients whose age at the time of obtaining consent is 20 to 80 years old.
•(3\) Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 to 1\.
•(4\) Patients who have histologically confirmed as extramamary Paget's disease.
•(5\) Patients who have HER2\-positive (IHC 3\+ or ISH\-positive) tumor tissue (primary, recurrent or metastatic lesion) confirmed by central pathological review and ISH analysis.
•(6\) Patients who have unresectable or metastatic extramammary Paget's disease
•(7\) Patients who have one or more measurable lesions (excluding primary lesions) defined in RECIST Guidelines Version 1\.1 by imaging within 14 days prior to enr ollment
•(8\) Patients who have laboratory parameters within Protocol\-defined range. The screening laboratory tests below must be done within 14 days before registration.
•\-Neutrophil count \>\= 1,500/mm3
•\-Platelets \>\= 100,000/mm3

•(1\) Patients who have clinically significant cardiac disease as follows:
•\- Grade 3 (CTCAE 5\.0\) or worse cardiac dysfunction or that specified in New York Heart Association (NYHA) classification class II to IV
•\- unstable angina pectoris, cardiac failure, myocardial infarction, or ventricular arrhythmia requiring medical treatment within the 6 months prior to registration
•(2\) Patients who have uncontrolled hypertension at the time of registration.
•(3\) Patients who have left ventricular ejection fraction (LVEF) of less than 50% by echocardiography within 28 days prior to registration.
•(4\) Patients who had been taken cumulative doxorubicin doses exceeding 500 mg/m2, or patients who had been other anthracycline drugs exceeding the equal cumulative dose (epirubicin: 900 mg / m2 or less, aclarubi cin: 600 mg or less, daunorubicin: 25 mg / kg or less, pirarubicin: 950 mg / m2 or less, mitoxantrone: 160 mg / m2 or less).
•(5\) Patients who have a history of hypersensitivity to the ingredients or additives of the study drug (sodium succinate, sucrose, polysorbate 20\).
•(6\) Patients who have brain metastasis which meet any of the following conditions.
•\- Have untreated or treatment\-required brain metastases at the time of registration.
•\- Have clinical symptoms within 60 days before registration