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Neoplasm, GastrointestinalPhase 2NCT03329690

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

A Phase 2 study testing DS-8201a and Physician's Choice in people with Neoplasm, Gastrointestinal, run by Daiichi Sankyo Co., Ltd. at 66 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Neoplasm, Gastrointestinal
What is being tested?
DS-8201a and Physician's Choice
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
233 participants
Where
66 sitesin 2 countries
Study dates
2 Nov 2017to 11 Dec 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Has a medical history of myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia
  • Has a QTc prolongation to > 450 millisecond (ms) in males and > 470 ms in females
  • Has a medical history of clinically significant lung disease
  • Is suspected to have certain other protocol-defined diseases based on imaging at screening period
  • 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:
  • safety or well-being of the participant or offspring
  • safety of study staff
  • analysis of results

Trial locations and contacts

66 sites in 2 countries.

66 sites in 2 countries

Japan48 sites

  • Hyogo Cancer Center

    Akashi, Hyōgo, 673-8558

  • Kansai Rosai Hospital

    Amagasaki, Hyōgo, 660-8511

  • Tokyo Metropolitan Komagome Hospital

    Bunkyō-Ku, Tokyo, 113-8677

  • Chiba Cancer Center

    Chiba, 260-8717

  • National Cancer Center Hospital

    Chuo Ku, Tokyo, 104-0045

  • Fukui Prefectural Hospital

    Fukui, 910-8526

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395

  • Kyushu University Hospital

    Fukuoka, 812-8582

  • Gifu University Hospital

    Gifu, 501-1194

  • Hirosaki University Hospital

    Hirosaki, Aomori, 036-8563

  • Hiroshima City Asa Citizens Hospital

    Hiroshima, 731-0293

  • Hiroshima Prefectural Hospital

    Hiroshima, 734-8530

  • Japanese Red Cross Kyoto Daini Hospital

    Kamigyō-ku, Kyoto, 602-8026

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641

  • Ibaraki Prefectural Central Hospital

    Kasama, Ibaraki, 309-1793

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

  • St. Marianna University School of Medicine Hospital

    Kawasaki, Kanagawa, 216-8511

  • Kagawa University Hospital

    Kita, Kagawa-ken, 761-0793

  • Japan Community Health Care Organization Kyushu Hospital

    Kitakyushu, Fukuoka, 806-8501

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047

  • Kochi Health Sciences Center

    Kochi, 781-8555

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koto-Ku, Tokyo, 135-8550

  • Showa University Koto Toyosu Hospital

    Koto-Ku, Tokyo, 135-8577

  • Kure Medical Center

    Kure, Hiroshima, 737-0023

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

  • Toranomon Hospital

    Minato-Ku, Tokyo, 105-8470

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, 464-8681

  • Miyagi Cancer Center

    Natori-shi, Miyagi, 981-1293

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Okayama University Hospital

    Okayama, 700-8558

  • Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital

    Osaka, 534-0021

  • Osaka International Cancer Institute

    Osaka, 541-8567

  • Osaka General Medical Center

    Osaka, 558-8558

  • Kindai University Hospital

    Osaka, 589-8511

  • Osaki Citizen Hospital

    Ōsaki, Miyagi, 989-6183

  • Gunma Prefectural Cancer Center

    Ōta, Gunma, 373-8550

  • The Kitasato Institute Kitasato University Hospital

    Sagamihara, Kanagawa, 252-0375

  • Saitama Cancer Center

    Saitama, 362-0806

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Iwate Medical University Hospital

    Shiwa-gun, Iwate, 028-3695

  • Shizuoka Cancer Center

    Shizuoka, 411-8777

  • Shizuoka General Hospital

    Shizuoka, 420-8527

  • Osaka University Hospital

    Suita, Osaka, 565-0871

  • Keio University Hospital

    Tokyo, 160-8582

  • Toyonaka Municipal Hospital

    Toyonaka, Osaka, 560-8565

  • Tochigi Cancer Center

    Utsunomiya, Tochigi, 320-0834

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

South Korea18 sites

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • Dong-A University Hospital

    Busan, 49201

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 28644

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

  • Chonnam National University Hwasun Hospital

    Gwangju, 58128

  • National Cancer Center

    Ilsan, Gyeonggi-do, 10408

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Chonbuk National University Hospital

    Jeonju, 54907

  • Seoul National University Bundang Hospital

    Seongnam, 13620

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Yonsei Cancer Center, Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Gangnam Severance Hospital

    Seoul, 06273

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591

  • Chung-Ang University Hospital

    Seoul, 06973

  • Korea University Guro Hospital

    Seoul, 08308

Other trials in South Korea

About this study

Official title: A Phase 2, Multicenter, Open-label Study of DS-8201a in Subjects With HER2-expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

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.

Being tested
DS-8201a, Physician's Choice
Keywords
Adenocarcinoma Metastatic, Adenocarcinoma of the Stomach, Adenocarcinoma of the Gastroesophageal Junction, HER2 Overexpression, Adenocarcinoma, Locally Advanced, DESTINY - Gastric 01
Medical subject headings
Gastrointestinal Neoplasms, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DS-8201aDrug

    Also called Experimental product

    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.

  • Physician's ChoiceDrug

    Also called Standard of Care

    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)

Study groups in NCT03329690
Study groupRoleWhat they receive
Parallel: DS-8201aExperimentalParticipants 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.
Receives: Drug: DS-8201a
Parallel: Physician's ChoiceActive comparatorParticipants 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.
Receives: Drug: Physician's Choice
Exploratory: Naïve HER2 IHC 2+/ISH-OtherA 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.
Receives: Drug: DS-8201a
Exploratory: Naïve HER2 IHC 1+OtherA maximum of 20 non-randomized patients with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma will receive DS-8201a once every 3 weeks.
Receives: Drug: DS-8201a

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Objective Response Rate Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)

    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 review (ICR) based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Unconfirmed ORR (not confirmed by ICR) and confirmed ORR (confirmed by ICR) are reported.

    Measured: Baseline to date of first documented objective response (CR or PR), up to 36 months postdose

  2. Percentage of Participants With Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)

    The best overall response is the best overall response (BOR) recorded from the start of the study treatment until the end of treatment and includes complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) and not evaluable (NE) as assessed by independent central imaging review (ICR) based on RECIST version 1.1. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. Unconfirmed BOR (not confirmed by ICR) and confirmed BOR (confirmed by ICR) are reported.

    Measured: Baseline to date of first documented objective response, up to 36 months postdose

Secondary outcomes (15)

  1. Overall Survival Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)

    Duration of survival follow-up (months) was defined as the date of last contact - date of randomization/ registration + 1.Overall Survival (OS) was defined as the time from the date of randomization (the date of the registration for the Exploratory Cohorts) to the date of death due to any cause.

    Measured: From the date of randomization to the date of death (due to any cause), up to 36 months postdose

  2. Progression-Free Survival Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)

    Progression-free survival (PFS) was defined as the time from the date of randomization (the date of the registration for the Exploratory Cohorts) to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause. PD was defined as at least a 20% increase in the sum of diameters of target lesions.

    Measured: From the date of randomization to the first documented disease progression or date of death (whichever occurs first), up to 36 months postdose

  3. Duration of Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set)

    Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR was measured for responding subjects (PR or CR) only.

    Measured: From the date of first objective response (CR or PR) to the date of first documentation of PD or death (whichever occurs first), up to 36 months postdose

  4. Disease Control Rate With and Without Confirmation by Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)

    Disease control rate (DCR) was defined as the sum of complete response (CR) rate, partial response (PR) rate, and stable disease (SD) rate. As per RECIST v1.1, CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.

    Measured: Baseline to date of first documented objective response (CR, PR, and SD), up to 36 months postdose

  5. Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)

    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 Review (ICR) based on RECIST version 1.1. The best overall response is the best overall response (BOR) recorded from the start of the study treatment until the end of treatment and includes CR, PR, stable disease (SD), progressive disease (PD) and not evaluable (NE) as assessed by Investigator based on RECIST version 1.1. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (at least a 20% increase in the sum of diameters of target lesions). Confirmed ORR and BOR (confirmed by ICR) are reported.

    Measured: From randomization to first documented objective response, up to 36 months postdose

  6. Time to Treatment Failure Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Full Analysis Set)

    Time to treatment failure (TTF) was defined as the time from the date of randomization (the date of the registration for Exploratory Cohorts) to the earliest date of the first objective documentation of progressive disease (PD), death due to any cause, or treatment discontinuation.

    Measured: From date of randomization to first documentation of PD, death due to any cause, or treatment discontinuation (whichever comes first), up to 36 months postdose

  7. Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set)

    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 Investigator based on RECIST version 1.1. The best overall response is the best overall response (BOR) recorded from the start of the study treatment until the end of treatment and includes CR, PR, stable disease (SD), progressive disease (PD) and not evaluable (NE) as assessed by Investigator based on RECIST version 1.1. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (at least a 20% increase in the sum of diameters of target lesions). Unconfirmed ORR and BOR (not confirmed by Investigator) and confirmed ORR and BOR (confirmed by Investigator) are reported.

    Measured: From randomization to first documented objective response, up to 36 months postdose

  8. Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a

    Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. The maximum serum concentration (Cmax) and the trough serum concentration (Ctrough) of DS-8201a were assessed. These serum PK parameters for DS-8201a and total anti-HER2 antibody were estimated in each participant using standard noncompartmental methods.

    Measured: Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days)

  9. Pharmacokinetic Parameter of Maximum Observed Serum Concentration (Cmax) and Trough Serum Concentration (Ctrough) of MAAA-1181 Following Treatment With DS-8201a

    Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. The maximum serum concentration (Cmax) and the trough serum concentration (Ctrough) of DS-8201a were assessed. These serum PK parameters for MAAA-1181a were estimated in each participant using standard noncompartmental methods.

    Measured: Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days)

  10. Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a

    Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. Area under the concentration versus time curve (AUC) from Time 0 to the Last Quantifiable Concentration (AUClast) and Area Under the Concentration versus-Time Curve up to 21 days (AUC21d) are reported. These serum PK parameters for DS-8201a and total anti-HER2 antibody were estimated in each participant using standard noncompartmental methods.

    Measured: Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days)

  11. Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of MAAA-1181 Following Treatment With DS-8201a

    Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. Area under the concentration versus time curve (AUC) from Time 0 to the Last Quantifiable Concentration (AUClast) and Area Under the Concentration versus-Time Curve up to 21 days (AUC21d) are reported. These serum PK parameters for MAAA-1181a were estimated in each participant using standard noncompartmental methods.

    Measured: Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days)

  12. Pharmacokinetic Parameter of Time to Maximum Serum Concentration (Tmax) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a

    Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. The time to maximum serum concentration (Tmax) of DS-8201a was assessed. This serum PK parameter for DS-8201a, total anti-HER2 antibody, and MAAA-1181a were estimated in each participant using standard noncompartmental methods.

    Measured: Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days)

  13. Pharmacokinetic Parameter Terminal Elimination Half-life (t1/2) of DS-8201a, Total Anti-HER2 Antibody and MAAA-1181 Following Treatment With DS-8201a

    Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. Terminal elimination half-life (t1/2) of DS-8201a was assessed. This serum PK parameter for DS-8201a, total anti-HER2 antibody, and MAAA-1181a were estimated in each participant using standard noncompartmental methods.

    Measured: Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days)

  14. Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set)

    A treatment-emergent adverse event (TEAE) is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.

    Measured: Baseline up to 47 days after last dose, up to 36 months postdose

  15. Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)

    A treatment-emergent adverse event (TEAE) is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.

    Measured: Baseline up to 47 days after last dose, up to 36 months postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2017
  2. Study start2 Nov 2017
  3. Primary completion8 Nov 2019
  4. Study completion11 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
233 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03329690
Sponsor's protocol ID
DS8201-A-J202
Other IDs
173727, DESTINY-G01
Status last verified
Mar 2022
First submitted
30 Oct 2017
Last updated
18 Mar 2022
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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/

Publications

  • Shitara K, Bang YJ, Iwasa S, Sugimoto N, Ryu MH, Sakai D, Chung HC, Kawakami H, Yabusaki H, Lee J, Saito K, Kawaguchi Y, Kamio T, Kojima A, Sugihara M, Yamaguchi K; DESTINY-Gastric01 Investigators. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Gastric Cancer. N Engl J Med. 2020 Jun 18;382(25):2419-2430. doi: 10.1056/NEJMoa2004413. Epub 2020 May 29.

    PubMed 32469182

  • Kapil A, Failmezger H, Fu Y, Spitzmuller A, Chan J, Haneder S, Shumilov A, Barkell A, Oguma T, Inaki K, Suto F, Allard J, Lee J, Lambert AW, Schick M, Barrett JC, Schmidt G, Sade H, Gustavson M, Carroll D, Cecchi F. Human Epidermal Growth Factor Receptor 2 Quantification Using Computational Pathology to Identify Novel Biomarkers for Trastuzumab Deruxtecan-Treated Human Epidermal Growth Factor Receptor 2-Positive Gastric Cancer. JCO Precis Oncol. 2026 May;10(5):e2500823. doi: 10.1200/PO-25-00823. Epub 2026 May 28.

    PubMed 42208007

  • Yamaguchi K, Bang YJ, Iwasa S, Sugimoto N, Ryu MH, Sakai D, Chung HC, Kawakami H, Yabusaki H, Lee J, Shimoyama T, Lee KW, Saito K, Kawaguchi Y, Kamio T, Kojima A, Sugihara M, Shitara K. Trastuzumab Deruxtecan in Anti-Human Epidermal Growth Factor Receptor 2 Treatment-Naive Patients With Human Epidermal Growth Factor Receptor 2-Low Gastric or Gastroesophageal Junction Adenocarcinoma: Exploratory Cohort Results in a Phase II Trial. J Clin Oncol. 2023 Feb 1;41(4):816-825. doi: 10.1200/JCO.22.00575. Epub 2022 Nov 15.

    PubMed 36379002

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DS-8201a and Physician's Choice in people with Neoplasm, Gastrointestinal, run by Daiichi Sankyo Co., Ltd. at 66 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in Japan, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Objective Response Rate Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set) (time frame: Baseline to date of first documented objective response (CR or PR), up to 36 months postdose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03329690, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.

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