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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 : Active, not recruiting
First Posted : July 10, 2019
Results First Posted : January 12, 2022
Last Update Posted : January 31, 2022
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adenocarcinoma Gastric Stage IV With Metastases
Adenocarcinoma - GEJ
Intervention Drug: Trastuzumab deruxtecan
Enrollment 79
Recruitment Details A total of 79 participants who met all inclusion criteria and no exclusion criteria were enrolled and treated at clinic centers in United States, Spain, Italy, United Kingdom, and Belgium. Primary results reported is from baseline up to data cut-off date of 09 April 2021. The results presented are based on primary analysis up to 16 months. Data collection is still on-going and additional results will be provided after study completion.
Pre-assignment Details  
Arm/Group Title Trastuzumab Deruxtecan
Hide Arm/Group Description Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer received an intravenous (IV) infusion 6.4 mg/kg dose of trastuzumab deruxtecan every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
Period Title: Overall Study
Started 79
Completed 23
Not Completed 56
Reason Not Completed
Progressive Disease             39
Adverse Event             9
Clinical Progression             2
Death             2
Withdrawal by Subject             2
Miscellaneous             1
Physician Decision             1
Arm/Group Title Trastuzumab Deruxtecan
Hide Arm/Group Description Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer treated with trastuzumab deruxtecan by intravenous (IV) infusion every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
Overall Number of Baseline Participants 79
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants
<=18 years
0
   0.0%
Between 18 and 65 years
46
  58.2%
>=65 years
33
  41.8%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 79 participants
60.7
(20.3 to 77.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants
Female
22
  27.8%
Male
57
  72.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants
American Indian or Alaska Native
0
   0.0%
Asian
4
   5.1%
Native Hawaiian or Other Pacific Islander
1
   1.3%
Black or African American
1
   1.3%
White
69
  87.3%
More than one race
0
   0.0%
Unknown or Not Reported
4
   5.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 79 participants
Belgium 4
United States 34
Italy 20
United Kingdom 17
Spain 4
1.Primary Outcome
Title Percentage of Participants With Objective Response Rate (ORR) Based on Independent Central Review Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma
Hide Description The Objective Response Rate (ORR) was the defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by independent central review (ICR) committee 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. Confirmed ORR based on ICR is reported.
Time Frame Up to 16 months (data cut-off)
Hide Outcome Measure Data
Hide Analysis Population Description
Objective response rate was assessed in the Full Analysis Set at data cut-off date of 09 April 2021.
Arm/Group Title Trastuzumab Deruxtecan
Hide Arm/Group Description:
Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer received an intravenous (IV) infusion 6.4 mg/kg dose of trastuzumab deruxtecan every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
Overall Number of Participants Analyzed 79
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
38.0
(27.3 to 49.6)
2.Secondary Outcome
Title Progression-Free Survival (PFS) Based on Independent Central Review Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma
Hide Description Progression-free survival (PFS) by independent central review was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.
Time Frame Up to 16 months (data cut-off)
Hide Outcome Measure Data
Hide Analysis Population Description
Progression-free survival (PFS) was assessed in the Full Analysis Set at data cut-off date of 09 April 2021.
Arm/Group Title Trastuzumab Deruxtecan
Hide Arm/Group Description:
Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer received an intravenous (IV) infusion 6.4 mg/kg dose of trastuzumab deruxtecan every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
Overall Number of Participants Analyzed 79
Median (95% Confidence Interval)
Unit of Measure: months
5.5
(4.2 to 7.3)
3.Secondary Outcome
Title Progression-Free Survival (PFS) Based on Investigator Assessment Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma
Hide Description Progression-free survival (PFS) by investigator assessment was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.
Time Frame Up to 16 months (data cut-off)
Hide Outcome Measure Data
Hide Analysis Population Description
Progression-free survival (PFS) was assessed in the Full Analysis Set at data cut-off date of 09 April 2021.
Arm/Group Title Trastuzumab Deruxtecan
Hide Arm/Group Description:
Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer received an intravenous (IV) infusion 6.4 mg/kg dose of trastuzumab deruxtecan every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
Overall Number of Participants Analyzed 79
Median (95% Confidence Interval)
Unit of Measure: months
5.5
(4.1 to 6.9)
4.Secondary Outcome
Title Objective Response Rate (ORR) Based on Investigator Assessment Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma
Hide Description The Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigator assessment 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. Confirmed ORR based on investigator assessment is reported.
Time Frame Up to 16 months (data cut-off)
Hide Outcome Measure Data
Hide Analysis Population Description
Objective response rate was assessed in the Full Analysis Set at data cut-off date of 09 April 2021.
Arm/Group Title Trastuzumab Deruxtecan
Hide Arm/Group Description:
Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer received an intravenous (IV) infusion 6.4 mg/kg dose of trastuzumab deruxtecan every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
Overall Number of Participants Analyzed 79
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
34.2
(23.9 to 45.7)
5.Secondary Outcome
Title Overall Survival (OS) Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma
Hide Description Overall survival (OS) was defined as the time from the date of first dose of study drug to the date of death due to any cause.
Time Frame Up to 16 months (data cut-off)
Hide Outcome Measure Data
Hide Analysis Population Description
Overall survival (OS) was assessed in the Full Analysis Set at data cut-off date of 09 April 2021.
Arm/Group Title Trastuzumab Deruxtecan
Hide Arm/Group Description:
Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer received an intravenous (IV) infusion 6.4 mg/kg dose of trastuzumab deruxtecan every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
Overall Number of Participants Analyzed 79
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(11.5 to NA)
[1]
Median OS and upper limit of 95% Confidence Interval (CI) was not estimable due to insufficient number of OS events.
6.Secondary Outcome
Title Duration of Response (DoR) Following Treatment With DS8201a in Participants With HER2-Positive Unresectable or Metastatic Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma
Hide Description 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 based on independent central review.
Time Frame Up to 16 months (data cut-off)
Hide Outcome Measure Data
Hide Analysis Population Description
Duration of Response (DOR) was assessed in the Full Analysis Set at data cut-off date of 09 April 2021.
Arm/Group Title Trastuzumab Deruxtecan
Hide Arm/Group Description:
Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer received an intravenous (IV) infusion 6.4 mg/kg dose of trastuzumab deruxtecan every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
Overall Number of Participants Analyzed 79
Median (95% Confidence Interval)
Unit of Measure: months
8.1 [1] 
(4.1 to NA)
[1]
The upper limit was not estimable due to the reason that the curve representing the upper confidence limits for the survivor function lies above 0.5.
Time Frame Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 17 months.
Adverse Event Reporting Description A Treatment-emergent adverse event (TEAE) is defined as an AE 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.
 
Arm/Group Title Trastuzumab Deruxtecan
Hide Arm/Group Description Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer received an intravenous (IV) infusion 6.4 mg/kg dose of trastuzumab deruxtecan every 3 weeks, until progression of disease or withdrawal from treatment for other reasons.
All-Cause Mortality
Trastuzumab Deruxtecan
Affected / at Risk (%)
Total   22/79 (27.85%) 
Hide Serious Adverse Events
Trastuzumab Deruxtecan
Affected / at Risk (%)
Total   29/79 (36.71%) 
Gastrointestinal disorders   
Nausea  1  4/79 (5.06%) 
Vomiting  1  3/79 (3.80%) 
Abdominal Pain  1  2/79 (2.53%) 
Colitis  1  1/79 (1.27%) 
Diarrhoea  1  1/79 (1.27%) 
Dysphagia  1  1/79 (1.27%) 
Enteritis  1  1/79 (1.27%) 
Haematemesis  1  1/79 (1.27%) 
Intestinal Obstruction  1  1/79 (1.27%) 
General disorders   
Disease Progression  1  2/79 (2.53%) 
Hyperpyrexia  1  1/79 (1.27%) 
Hepatobiliary disorders   
Bile Duct Stenosis  1  1/79 (1.27%) 
Hepatotoxicity  1  1/79 (1.27%) 
Infections and infestations   
Covid-19  1  2/79 (2.53%) 
Pneumonia  1  2/79 (2.53%) 
Bacterial Sepsis  1  1/79 (1.27%) 
Covid-19 Pneumonia  1  1/79 (1.27%) 
Device Related Infection  1  1/79 (1.27%) 
Staphylococcal Infection  1  1/79 (1.27%) 
Urinary Tract Infection  1  1/79 (1.27%) 
Wound Infection  1  1/79 (1.27%) 
Injury, poisoning and procedural complications   
Animal Bite  1  1/79 (1.27%) 
Exposure To Communicable Disease  1  1/79 (1.27%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Malignant Neoplasm Progression  1  2/79 (2.53%) 
Lymphangiosis Carcinomatosa  1  1/79 (1.27%) 
Tumour Haemorrhage  1  1/79 (1.27%) 
Nervous system disorders   
Basal Ganglia Infarction  1  1/79 (1.27%) 
Cerebrovascular Accident  1  1/79 (1.27%) 
Generalised Tonic-Clonic Seizure  1  1/79 (1.27%) 
Product Issues   
Device Occlusion  1  1/79 (1.27%) 
Renal and urinary disorders   
Acute Kidney Injury  1  2/79 (2.53%) 
Hydronephrosis  1  1/79 (1.27%) 
Urinary Tract Obstruction  1  1/79 (1.27%) 
Respiratory, thoracic and mediastinal disorders   
Interstitial Lung Disease  1  2/79 (2.53%) 
Pneumonitis  1  1/79 (1.27%) 
Pulmonary Embolism  1  1/79 (1.27%) 
1
Term from vocabulary, MedDRA (23.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Trastuzumab Deruxtecan
Affected / at Risk (%)
Total   79/79 (100.00%) 
Blood and lymphatic system disorders   
Anaemia  1  27/79 (34.18%) 
Neutropenia  1  8/79 (10.13%) 
Gastrointestinal disorders   
Nausea  1  52/79 (65.82%) 
Vomiting  1  33/79 (41.77%) 
Diarrhoea  1  27/79 (34.18%) 
Constipation  1  21/79 (26.58%) 
Abdominal Pain  1  13/79 (16.46%) 
Gastrooesophageal Reflux Disease  1  8/79 (10.13%) 
Ascites  1  5/79 (6.33%) 
Dysphagia  1  5/79 (6.33%) 
General disorders   
Fatigue  1  32/79 (40.51%) 
Asthenia  1  12/79 (15.19%) 
Pyrexia  1  8/79 (10.13%) 
Oedema Peripheral  1  4/79 (5.06%) 
Infections and infestations   
Covid-19  1  4/79 (5.06%) 
Device Related Infection  1  4/79 (5.06%) 
Investigations   
Weight Decreased  1  27/79 (34.18%) 
Platelet Count Decreased  1  13/79 (16.46%) 
Neutrophil Count Decreased  1  12/79 (15.19%) 
Aspartate Aminotransferase Increased  1  9/79 (11.39%) 
White Blood Cell Count Decreased  1  7/79 (8.86%) 
Alanine Aminotransferase Increased  1  6/79 (7.59%) 
Blood Alkaline Phosphatase Increased  1  6/79 (7.59%) 
Blood Bilirubin Increased  1  4/79 (5.06%) 
Metabolism and nutrition disorders   
Decreased Appetite  1  26/79 (32.91%) 
Hypokalaemia  1  12/79 (15.19%) 
Hypoalbuminaemia  1  6/79 (7.59%) 
Hyponatraemia  1  6/79 (7.59%) 
Hypophosphataemia  1  4/79 (5.06%) 
Musculoskeletal and connective tissue disorders   
Back Pain  1  7/79 (8.86%) 
Nervous system disorders   
Headache  1  6/79 (7.59%) 
Dizziness  1  5/79 (6.33%) 
Psychiatric disorders   
Insomnia  1  5/79 (6.33%) 
Depression  1  4/79 (5.06%) 
Renal and urinary disorders   
Urinary Retention  1  5/79 (6.33%) 
Acute Kidney Injury  1  4/79 (5.06%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  7/79 (8.86%) 
Cough  1  6/79 (7.59%) 
Epistaxis  1  6/79 (7.59%) 
Interstitial Lung Disease  1  4/79 (5.06%) 
Pneumonitis  1  4/79 (5.06%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  19/79 (24.05%) 
Vascular disorders   
Hypotension  1  4/79 (5.06%) 
1
Term from vocabulary, MedDRA (23.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Contact for Clinical Trial Information
Organization: Daiichi Sankyo
Phone: 1-908-992-6400
EMail: CTRinfo@dsi.com
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 Submitted: July 8, 2019
First Posted: July 10, 2019
Results First Submitted: December 14, 2021
Results First Posted: January 12, 2022
Last Update Posted: January 31, 2022