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DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01]

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ClinicalTrials.gov Identifier: NCT03329690
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )

Brief 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.

Condition or disease Intervention/treatment Phase
Neoplasm, Gastrointestinal Drug: DS-8201a Drug: Physician's Choice Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Two randomized investigative arms will run in parallel (DS-8201a and Physician's Choice), with participants who have disease progression after two previous regimens.

Two non-randomized exploratory arms will run with HER2 treatment-naive participants.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Open-label Study of DS-8201a in Subjects With HER2-expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Actual Study Start Date : October 12, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Parallel: DS-8201a
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease has progressed on two prior regimens, will receive DS-8201a once every 3 weeks.
Drug: DS-8201a
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.
Other Name: Experimental product

Active Comparator: Parallel: Physician's Choice
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease has progressed on two prior regimens, will receive monotherapy prescribed by the physician before enrollment.
Drug: Physician's Choice

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)

Other Name: Standard of Care

Exploratory: Naïve HER2 IHC 2+/ISH-
A maximum of 20 non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma will receive DS-8201a once every three weeks.
Drug: DS-8201a
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.
Other Name: Experimental product

Exploratory: Naïve HER2 IHC 1+
A maximum of 20 non-randomized patients with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma will receive DS-8201a once every 3 weeks.
Drug: DS-8201a
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.
Other Name: Experimental product




Primary Outcome Measures :
  1. Percentage of Randomized Participants with Objective Response [ Time Frame: within 22 months ]
    The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response [CR] or Partial Response [PR], assessed by independent central imaging facility review based on RECIST version 1.1.


Secondary Outcome Measures :
  1. Percentage of Randomized Participants with Progression-free survival (PFS) [ Time Frame: within 22 months ]
    Percentage of participants still alive without the disease getting worse

  2. Overall Survival (OS) [ Time Frame: at 22 months ]
    Percentage of participants still alive

  3. Duration of Response (DoR) [ Time Frame: within 22 months ]
    Length of time the response continued

  4. Disease Control Rate (DCR) [ Time Frame: within 22 months ]
    Percentage of participants who achieved a best overall response of CR or PR or Stable Disease (SD).

  5. Time to Treatment Failure (TTF) [ Time Frame: within 22 months ]
    Time from the date of randomization (the date of the registration for Exploratory Cohorts) to the earliest date of the first radiographic Progressive Disease (PD), death due to any cause, or treatment discontinuation

  6. ORR as Assessed by the Investigator [ Time Frame: within 22 months ]
    Percentage of participants who achieved a best overall response of Complete Response [CR] or Partial Response [PR], as assessed by the investigator, based on RECIST version 1.1.

  7. Maximum concentration (Cmax) [ Time Frame: within 21 days ]
    Categories: DS-8201a, total anti-HER2 antibody, MAAA-1181a

  8. Time to Cmax (Tmax) [ Time Frame: within 21 days ]
    Categories: DS-8201a, total anti-HER2 antibody, MAAA-1181a

  9. Area under the concentration-time curve (AUC) from dosing until the last quantifiable concentration (AUClast) [ Time Frame: within 21 days ]
    Categories: DS-8201a, total anti-HER2 antibody, MAAA-1181a

  10. AUC from the time of dosing until day 21 (AUC0-21) [ Time Frame: at Day 21 ]
    Categories: DS-8201a, total anti-HER2 antibody, MAAA-1181a



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Has a pathologically documented locally advanced or metastatic adenocarcinoma of gastric or gastroesophageal junction
  2. Progression on and after at least 2 prior regimens
  3. Has an adequate tumor sample
  4. Has measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1

Exclusion Criteria:

  1. Has a medical history of myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia
  2. Has a QTc prolongation to > 450 millisecond (ms) in males and > 470 ms in females
  3. Has a medical history of clinically significant lung disease
  4. Is suspected to have certain other protocol-defined diseases based on imaging at screening period
  5. Has history of any disease, metastatic condition, drug/medication use or other condition that might, per protocol or in the opinion of the investigator, compromise:

    1. safety or well-being of the participant or offspring
    2. safety of study staff
    3. analysis of results

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): NCT03329690


Contacts
Contact: Daiichi Sankyo Contact for Clinical Trial Information +81-3-6225-1111 (M-F 9-5 JST) dsclinicaltrial@daiichisankyo.co.jp

  Show 56 Study Locations
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Investigators
Study Director: Global Clinical Leader Daiichi Sankyo, Inc.

Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT03329690     History of Changes
Other Study ID Numbers: DS8201-A-J202
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018
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://www.clinicalstudydatarequest.com//. 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://www.clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-DS.aspx
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
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://www.clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-DS.aspx

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):
Adenocarcinoma Metastatic
Adenocarcinoma of the Stomach
Adenocarcinoma of the Gastroesophageal Junction
HER2 Overexpression
Adenocarcinoma, Locally Advanced
DESTINY - Gastric 01

Additional relevant MeSH terms:
Adenocarcinoma
Gastrointestinal Neoplasms
Digestive System Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Camptothecin
Immunoconjugates
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs