DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02)
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|ClinicalTrials.gov Identifier: NCT04014075|
Recruitment Status : Recruiting
First Posted : July 10, 2019
Last Update Posted : May 18, 2020
This study will find out if trastuzumab deruxtecan is safe and works for participants with certain kinds of cancer.
They must have HER2-positive gastric or gastro-esophageal junction (GEJ) cancer:
- that cannot be removed surgically
- that has moved to other parts of the body
- that got worse during or after treatment that included trastuzumab
The study will enroll about 72 participants at about 25 to 30 sites. Sites will be in North America, Australia, Israel, and the European Union. There might be other countries as well.
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma Gastric Stage IV With Metastases Adenocarcinoma - GEJ||Drug: Trastuzumab deruxtecan||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Open-label, Single-arm Trial of Trastuzumab Deruxtecan (DS 8201a) in HER2-positive, Unresectable or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma Subjects Who Have Progressed on or After a Trastuzumab-containing Regimen (DESTINY-Gastric02)|
|Actual Study Start Date :||July 30, 2019|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||August 2021|
Experimental: All participants
Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer will be treated with trastuzumab deruxtecan by intravenous (IV) infusion every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
Drug: Trastuzumab deruxtecan
Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion
Other Name: DS-8201a
- Objective Response Rate (ORR), Confirmed by Independent Central Review [ Time Frame: within approximately 30 months ]ORR is defined as the percentage of participants with Best Response of Complete Response (CR) or Partial Response (CR), assessed by Independent Central Review using Response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)
- Progression-Free Survival (PFS), based on Independent Central Review using RECIST v1.1 [ Time Frame: within approximately 30 months ]PFS is defined as the time from enrollment until objective tumor progression or withdrawing from the study for other reasons, whichever occurs first.
- PFS, based on Investigator Assessment [ Time Frame: within approximately 30 months ]The time from enrollment until disease progression or withdrawing from the study for other reasons, whichever occurs first, as assessed by the Investigator
- ORR, based on Investigator Assessment [ Time Frame: within approximately 30 months ]The percentage of participants with Best Response of Complete Response (CR) or Partial Response (PR), assessed by the Investigator
- Overall Survival (OS) [ Time Frame: within approximately 30 months ]Overall survival is defined as the time from enrollment until death from any cause, and is measured in the intent-to-treat population.
- Duration of Response (DoR) [ Time Frame: within approximately 30 months ]DoR is defined as the length of time the Best Response of CR or PR continued
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04014075
|Contact: Contact for Clinical Trial Information||908-992-6400||CTRinfo@dsi.com|
|Study Director:||Global Clinical Leader||Daiichi Sankyo, Inc.|