Trastuzumab Emtansine in patients with advanced HER2-positive extramammary Paget's disease: a phase ll trial

Phase 2

Recruiting

• Conditions: HER2-positive advanced extramammary Paget's disease; Other disease of skin or skin tissue

• Registration Number: JPRN-jRCTs031200064
• Lead Sponsor: Funakoshi Takeru

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-03
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1) Have histologically confirmed as extramammary Paget's disease.
2) Have unresectable or metastatic extramammary Paget's disease.
3) Have a HER2-positive (immunohistochemistry 3+, immunohistochemistry 2+ and in-situ hybridisation-positive) confirmed by central pathological review and ISH analysis.
4) Have been treated by trastuzumab.
5) Have no prior treatment with trastuzumab emtansine.
6) Have an Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
7) Have laboratory parameters within Protocol-defined range. The screening laboratory tests below must be done within 14 days before registration.
-White blood cell count >= 2,000/mm3, absolute neutrophil count >= 1,500/mm3
-Platelets >= 100,000/mm3
-Hemoglobin >= 9.0g/dl
-Aspartate aminotransferase (AST), alanine aminotransferase (ALT) <= 3X upper limit of normal (ULN)
-Total bilirubin <= 1.5X ULN
-Serum creatinine <= 1.5mg/dl
-Left ventricular ejection fraction (LVEF) >= 50%
8) Have no abnormality in electrocardiogram within 4 weeks prior to registration.
9) Be aged 20 years or older.
10) Have the presence of at least one measurable lesion by image per RECIST 1.1.
11) Agreed to use an adequate method of contraception (non-pregnant women in reproductive age and men), or refrain from breast-feeding (mothers), after giving IC and until 210 days after the last dose of the study treatment.
12) Provide written informed consent for the study.

Exclusion Criteria

1) Has serious complication.
2) Seropositivity to HBsAg or HCVAb.
3) Has known history of HIV.
4) Has active interstitial pneumonia.
5) Has intractable pleural and pericardical effusion, or ascites.
6) Has known no active central nervous system (CNS) metastases
7) Has a known additional malignancy that is progressing or requires active treatment.
8) Has New York Heart Association (NYHA) Class II, III, IV, or grade 3 or worse cardiac disorders (CTCAE v4.0).
9) Has a history of myocardial infarction, angina pectoris, cardiac failure, or arrhythmia requiring medical treatment within the 6 months prior to registration
10) Has intractable hypertension.
11) Has grade 3 or worse peripheral neuropathy (CTCAE v4.0).
12) Has mental disorder or psychiatric condition who is judged to be difficult to participate in this study.
13) Has a history of hypersensitivity to trastuzumab or trastuzumab emtansine.
14) Pregnant or breast-feeding women or women suspected of being pregnant.
15) Other investigational new drugs or unlicensed drugs within the 30 days prior to registration.
16) Be determined as being an inappropriate study case by the trial responsibility physicians or trial allotment physicians.

Study & Design

• Study Type: Interventional
• Study Design: Not specified