Phase II, multicenter, open-label study of Trastuzumab derxtecan in patients with HER2-expressing recurrent and or metastatic salivary gland carcinoma
Phase 2
Recruiting
- Conditions
- HER2-expressing recurrent and/or metastatic salivary gland carcinomaHER2-expressing, salivary gland carcinoma, recurrent and/or metastatic
- Registration Number
- JPRN-jRCT2011210017
- Lead Sponsor
- Hirotoshi Akita
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 52
Inclusion Criteria
20 years and over at the time of written informed consent
Histologically confirmed recurrent and or metastatic salivary gland carcinoma
No indication for curative treatment
Tumor tissue or undryed glass specimen is available
IHC 3 plus IHC 2 plus IHC 1 plus and or ISH plus
Patient with measurable lesion by RECIST version 1.1
ECOG performance status of 0 or 1
Adequate organ function
Exclusion Criteria
History and complication of myocardial infarction or congestive heart failure
Prolonged QT interval
Complication of Interstitial lung disease
Active central nervous system metastasis
Other active malignancies
Prior treatment with ADC of Exatecan derivative Topoisomerase I inhibitor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective Response Rate by the Independent Central Image Committee
- Secondary Outcome Measures
Name Time Method Efficacy: Best percent change in sum of diameter for tumor<br> Disease control rate<br> Progression free survival<br> Overall survival<br> Objective response rate by Principal Investigators<br>Safety