Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04014075
Recruitment Status : Recruiting
First Posted : July 10, 2019
Last Update Posted : May 18, 2020
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Brief Summary:

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Trastuzumab

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  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.

  2. 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

  3. 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

  4. 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.

  5. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women ≥18 years old (local regulatory guidelines apply)
  • Has pathologically documented HER2-positive gastric or GEJ cancer that is unresectable or metastatic, and that progressed during or after treatment regimen containing trastuzumab
  • Has at least one measurable lesion per RECIST v1.1, as confirmed by independent central review
  • If of reproductive potential, agrees to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 4.5 months after the last dose of study drug
  • Has protocol-defined adequate cardiac, renal and hepatic function

Exclusion Criteria:

  • Has had anticancer therapy after first-line treatment regimen containing trastuzumab
  • Has uncontrolled cardiovascular disease, including any of the following: history of myocardial infarction (MI) within 6 months of enrollment or symptomatic congestive heart failure (New York Heart Association Class II to IV), troponin levels consistent with MI as defined according to the manufacturer within 28 days prior to enrollment, history of unstable angina or serious cardiac arrhythmia requiring treatment, or corrected QT interval (QTc) prolongation to >470 ms (females) or >450 ms (male) based on screening triplicate 12-lead electrocardiogram (ECG)
  • Has history of non-infectious interstitial lung disease (ILD) or pneumonitis that required corticosteroid therapy, or current ILD/pneumonitis that cannot be ruled out at screening
  • Has clinically significant corneal disease or any other condition or disease that, per protocol or in the opinion of the investigator, precludes participation
  • Has pleural effusion, ascites, or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART)
  • Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms (Note: participants with clinically inactive brain metastases may be included in the study as well as participants with treated brain metastases who are no longer symptomatic and no longer require treatment with corticosteroids or anticonvulsants.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Contact for Clinical Trial Information 908-992-6400 CTRinfo@dsi.com

Locations
Show Show 24 study locations
Sponsors and Collaborators
Daiichi Sankyo, Inc.
AstraZeneca
Investigators
Layout table for investigator information
Study Director: Global Clinical Leader Daiichi Sankyo, Inc.
Layout table for additonal information
Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT04014075    
Other Study ID Numbers: DS8201-A-U205
2019-001512-34 ( EudraCT Number )
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
URL: https://vivli.org/ourmember/daiichi-sankyo/

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daiichi Sankyo, Inc.:
Human epidermal receptor 2 positive
Unresectable or metastatic
HER2
Prior treatment regimen included trastuzumab
Additional relevant MeSH terms:
Layout table for MeSH terms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents