Phase 1 study of DS-8201a in subjects with advanced solid malignant tumors
- Conditions
- advanced solid malignant tumors
- Registration Number
- JPRN-jRCT2080222926
- Lead Sponsor
- DAIICHISANKYO Co.,Ltd., DAIICHI SANKYO, INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 278
1. Age >= 20 years in Japan, >= 18 years in the United States.
2. Eastern Cooperative Oncology Group performance status(PS) of 0 or 1.
3. Left ventricular ejection fraction (LVEF) >= 50%
Part 1:
1. Advanced/unresectable or metastatic breast cancer or gastric or gastroesophageal junction adenocarcinoma that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
Part 2a:
1. Advanced breast cancer with HER2 overexpression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
2.Treated with T-DM1
Part 2b:
1. Advanced gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
2. Treated with trastuzumab
Part 2c:
1. Advanced breast cancer with HER2 low expression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
Part 2d:
Satisfy at least one of the following criteria
1. Advanced/unresectable or metastatic solid malignant tumor with HER2 expression other than breast cancer and gastric or gastroesophageal junction adenocarcinoma that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
2. Advanced/unresectable or metastatic tumor with HER2 mutation that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
Part 2e
1. Advanced breast cancer with HER2 overexpression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
2. Treated with ado-trastuzumab emtansine (T-DM1) (patients with HER2 overexpression only)
1.Has a medical history of symptomatic CHF (New York Heart Association; NYHA classes II-IV) or serious cardiac arrhythmia.
2.Has a medical history of myocardial infarction or unstable angina.
3.Has a QTc prolongation to > 450 millisecond (ms) in males and > 470 ms in females.
4.Has a medical history of clinically significant lung diseases
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method