Phase 2 study of DS-8201a in subjects with gastric cancer [DESTINY-Gastric01]
- Conditions
- Gastric or gastroesophageal junction adenocarcinoma
- Registration Number
- JPRN-jRCT2080223671
- Lead Sponsor
- DAIICHI SANKYO CO., LTD.
- Brief Summary
The efficacy and safety findings of this study demonstrated the positive benefit/risk ratio of DS-8201a in HER2 positive patients with advanced gastric or GEJ adenocarcinoma who have progressed on 2 or more regimens including fluoropyrimidine agent, platinum agent, and trastuzumab. DS-8201a demonstrated antitumor activity in patients with HER2-low (IHC 2+/ISH-, IHC 1+) advanced gastric or GEJ adenocarcinoma
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 233
Has a pathologically documented locally advanced or metastatic adenocarcinoma of gastric or gastroesophageal junction.
- Progression on and after at least 2 prior regimens which had to include a fluoropyrimidine and a platinum.
- Has measurable disease assessed by the investigator based on RECIST version 1.1.
- Has an ECOG PS of 0 to 1
- Has a medical history of clinically significant lung disease
- Has clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy
- Has had non-gastric or gastroesophageal junction primary malignancies within 3 years
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 safety<br>efficacy<br>pharmacokinetics<br>Progression-free survival, Overall survival, Duration of response, Disease control rate, Time to treatment failure, Safety, Pharmacokinetic<br>RECIST Version 1.1