At a glance
ClinicalIndex Comparison Record- ✓Pathologically documented locally advanced or metastatic adenocarcinoma of gastric or gastroesophageal junction
- ✓Progression on and after at least 2 prior regimens
- ✓Adequate tumor sample available
- ✓Measurable disease by RECIST v1.1
- ✕Medical history of myocardial infarction, symptomatic CHF (NYHA classes II-IV), unstable angina, or serious cardiac arrhythmia
- ✕QTc prolongation >450 ms in males or >470 ms in females
- ✕Medical history of clinically significant lung disease
- ✕Suspected protocol-defined diseases based on screening imaging
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Multicenter, Open-label Study of DS-8201a in Subjects With HER2-expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
In Brief
A Phase 2 clinical trial evaluating DS-8201a and Physician's Choice for Neoplasm, Gastrointestinal. Completed, enrolled 233 participants across 66 sites in 2 countries.
Detailed Summary
The primary purpose of this trial is to compare the efficacy and safety of DS-8201a and physician's choice treatment in HER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma patients who have progressed on two prior treatment regimens including fluoropyrimidine agent, platinum agent, and trastuzumab.
Study Details
Timeline
Interventions
DS-8201a is comprised of an antibody component conjoined to a drug component in a lyophilized powder, which is made into solution for intravenous administration.
Either: Irinotecan monotherapy (Starting dosage and usage is 150 mg/m2 biweekly, with dose reduction permitted) Paclitaxel monotherapy (Starting dosage and usage is 80 mg/m2 weekly, with dose reduction permitted)