CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
DS-8201adrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03368196
NCT03368196Phase 1Completed
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Phase 1, Multicenter, Open-label Study of DS-8201a to Assess Safety and Pharmacokinetics in Subjects With HER2-Positive Advanced and/or Refractory Gastric, Gastroesophageal Junction Adenocarcinoma, or Breast Cancer

Daiichi Sankyo Taiwan Ltd., a Daiichi Sankyo Company·interventional·Posted Dec 11, 2017·Updated Nov 3, 2022

In Brief

A Phase 1 clinical trial evaluating DS-8201a for Adenocarcinoma, Gastric and Neoplasm, Breast. Completed, enrolled 12 participants across 2 sites.

Detailed Summary

HER2-positive cancer is a cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2). HER2 promotes the growth of certain cancer cells. This study will test DS-8201a (trastuzumab deruxtecan), a HER2-targeted antibody and topoisomerase I inhibitor conjugate. The safety and tolerability profile of DS-8201a will be assessed in Chinese patients with certain types of stomach and breast cancer that test positive for HER2. It also will test how DS-8201a moves within the body (pharmacokinetics).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdenocarcinoma, Gastric, Neoplasm, Breast
CountriesTaiwan
CollaboratorsAstraZeneca

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedDec 11, 2017
Enrollment StartApr 2, 2018
Primary CompletionSep 14, 2018
Study CompletionSep 28, 2022
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.6 years ago

Interventions

DS-8201adrug

An antibody drug conjugate