Phase 2 study of DS-8201a in subjects with colorectal cancer [DESTINY-CRC01]
- Conditions
- Colorectal cancer
- Registration Number
- JPRN-jRCT2080223752
- Lead Sponsor
- DAIICHI SANKYO CO., LTD.
- Brief Summary
Overall, DS-8201a demonstrated clinically meaningful response rates in subjects with HER2-overexpressing mCRC refractory to standard therapies. In the context of existing data available from current standard therapy in patient populations similar to those enrolled in this study, the efficacy and safety findings of this study warrant further development of DS-8201a in patients with HER2-overexpressing mCRC.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 86
Age >= 20 years in Japan, >= 18 years in the rest of the countries.
- Pathologically documented unresectable, recurrent, or metastatic colorectal adenocarcinoma. Until sponsor's notification to the study sites, subject must be a RAS/BRAF wild-type cancer.
- Received at least 2 prior regimens of standard treatment.
- Has measurable disease assessed by the investigator based on RECIST version 1.1.
- Has an ECOG PS of 0 to 1
- Medical history of myocardial infarction within 6 months, symptomatic congestive heart failure
- Has a medical history of clinically significant lung disease
- Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>The objective response rate<br>RECIST Version 1.1
- Secondary Outcome Measures
Name Time Method efficacy<br>pharmacokinetics<br>Progression-free survival, Overall survival, Duration of response, Disease control rate, Safety, Pharmacokinetic<br>RECIST Version 1.1