A Phase 2, multicenter, open-label study of DS-8201a in subjects with HER2-expressing advanced colorectal cancer
- Conditions
- Human epidermal growth factor receptor 2 (HER2)- expressing advanced colorectal cancerTherapeutic area: Diseases [C] - Cancer [C04]MedDRA version: 21.0Level: LLTClassification code 10010029Term: Colorectal cancer NOSSystem Organ Class: 100000004864
- Registration Number
- EUCTR2017-003466-28-IT
- Lead Sponsor
- DAIICHI SANKYO INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 78
1. Pathologically documented unresectable, recurrent, or metastatic
colorectal adenocarcinoma. Until sponsor's notification to the study
sites, subject must be a (BRAF) wild-type cancer.
2. Received at least 2 prior regimens of standard treatment.
3. Has measurable disease assessed by the investigator based on RECIST
version 1.1.
4. Has an Eastern Cooperative Oncology Group Performance Status (ECOG
PS) of 0 to 1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
1. Medical history of myocardial infarction within 6 months before enrollment (study treatment), symptomatic congestive heart failure
2 Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
3. Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method