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DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing Colorectal Cancer (DESTINY-CRC01)

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ClinicalTrials.gov Identifier: NCT03384940
Recruitment Status : Completed
First Posted : December 28, 2017
Results First Posted : August 24, 2021
Last Update Posted : August 24, 2021
Sponsor:
Collaborators:
Daiichi Sankyo, Inc.
AstraZeneca
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Neoplasm
Intervention Drug: DS-8201a
Enrollment 86
Recruitment Details A total of 86 participants who met all inclusion criteria and no exclusion criteria were enrolled and treated at clinic centers in Japan, United States, Spain, and Italy.
Pre-assignment Details After tissue screening, a total of 86 participants were eligible based on confirmation of HER2 status.
Arm/Group Title DS-8201a Cohort A DS-8201a Cohort B DS-8201a Cohort C
Hide Arm/Group Description Participants in Cohort A were HER2-positive (IHC 3+ or IHC 2+/ISH +) who received DS-8201a once every 3 weeks. Participants in Cohort B were HER2 IHC 2+/ISH - who received DS-8201a once every 3 weeks. Participants in Cohort C were HER2/IHC 1+ who received DS-8201a once every 3 weeks.
Period Title: Overall Study
Started 53 15 18
Completed [1] 0 0 0
Not Completed 53 15 18
Reason Not Completed
Progressive disease             36             11             13
Clinical progression             4             0             3
Adverse Event             7             1             1
Withdrawal by Subject             3             1             0
Physician Decision             1             1             0
Death             2             1             0
Other             0             0             1
[1]
As of database lock for final analysis on 28 Dec 2020
Arm/Group Title DS-8201a Cohort A DS-8201a Cohort B DS-8201a Cohort C Total
Hide Arm/Group Description Participants in Cohort A were HER2-positive (IHC 3+ or IHC 2+/ISH +) who received DS-8201a once every 3 weeks. Participants in Cohort B were HER2 IHC 2+/ISH - who received DS-8201a once every 3 weeks. Participants in Cohort C were HER2/IHC 1+ who received DS-8201a once every 3 weeks. Total of all reporting groups
Overall Number of Baseline Participants 53 15 18 86
Hide Baseline Analysis Population Description
The baseline demographic characteristics were derived from the Full Analysis Set.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 15 participants 18 participants 86 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
35
  66.0%
8
  53.3%
13
  72.2%
56
  65.1%
>=65 years
18
  34.0%
7
  46.7%
5
  27.8%
30
  34.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants 15 participants 18 participants 86 participants
57.5  (11.72) 61.5  (11.95) 58.5  (9.97) 58.4  (11.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 15 participants 18 participants 86 participants
Female
28
  52.8%
5
  33.3%
7
  38.9%
40
  46.5%
Male
25
  47.2%
10
  66.7%
11
  61.1%
46
  53.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 15 participants 18 participants 86 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
16
  30.2%
3
  20.0%
8
  44.4%
27
  31.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
34
  64.2%
11
  73.3%
8
  44.4%
53
  61.6%
More than one race
1
   1.9%
0
   0.0%
1
   5.6%
2
   2.3%
Unknown or Not Reported
2
   3.8%
1
   6.7%
1
   5.6%
4
   4.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 53 participants 15 participants 18 participants 86 participants
United States 10 3 1 14
Japan 15 3 8 26
Italy 26 7 8 41
Spain 2 1 1 4
United Kingdom 0 1 0 1
1.Primary Outcome
Title Number of Participants With Best Objective Response Based on Independent Central Review (Confirmed and Unconfirmed) Following DS-8201a Treatment in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Advanced Colorectal Cancer
Hide Description Best objective response was reported based on independent central review. As per Response Evaluation Criteria In Solid Tumors (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 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.
Time Frame Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 18 months post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Response was assessed in the Full Analysis Set.
Arm/Group Title DS-8201a Cohort A DS-8201a Cohort B DS-8201a Cohort C
Hide Arm/Group Description:
Participants in Cohort A were HER2-positive (IHC 3+ or IHC 2+/ISH +) who received DS-8201a once every 3 weeks.
Participants in Cohort B were HER2 IHC 2+/ISH - who received DS-8201a once every 3 weeks.
Participants in Cohort C were HER2/IHC 1+ who received DS-8201a once every 3 weeks.
Overall Number of Participants Analyzed 53 15 18
Measure Type: Count of Participants
Unit of Measure: Participants
Confirmed CR
0
   0.0%
0
   0.0%
0
   0.0%
Confirmed PR
24
  45.3%
0
   0.0%
0
   0.0%
Confirmed SD
20
  37.7%
9
  60.0%
4
  22.2%
Confirmed PD
5
   9.4%
5
  33.3%
10
  55.6%
Confirmed Non-evaluable
4
   7.5%
1
   6.7%
4
  22.2%
Unconfirmed CR
0
   0.0%
0
   0.0%
0
   0.0%
Unconfirmed PR
26
  49.1%
0
   0.0%
0
   0.0%
Unconfirmed SD
18
  34.0%
9
  60.0%
4
  22.2%
Unconfirmed PD
5
   9.4%
5
  33.3%
10
  55.6%
Unconfirmed Non-evaluable
4
   7.5%
1
   6.7%
4
  22.2%
2.Primary Outcome
Title Number of Participants With Objective Response Rate Based on Independent Central Review (Confirmed and Unconfirmed) Following DS-8201a Treatment in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Advanced Colorectal Cancer
Hide Description Objective response rate (defined as CR+PR) was reported based on independent central review. As per Response Evaluation Criteria In Solid Tumors (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.
Time Frame Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 18 months post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Response was assessed in the Full Analysis Set.
Arm/Group Title DS-8201a Cohort A DS-8201a Cohort B DS-8201a Cohort C
Hide Arm/Group Description:
Participants in Cohort A were HER2-positive (IHC 3+ or IHC 2+/ISH +) who received DS-8201a once every 3 weeks.
Participants in Cohort B were HER2 IHC 2+/ISH - who received DS-8201a once every 3 weeks.
Participants in Cohort C were HER2/IHC 1+ who received DS-8201a once every 3 weeks.
Overall Number of Participants Analyzed 53 15 18
Measure Type: Count of Participants
Unit of Measure: Participants
Confirmed CR+PR
24
  45.3%
0
   0.0%
0
   0.0%
Confirmed CR+PR (within 3 months)
10
  18.9%
0
   0.0%
0
   0.0%
Confirmed CR+PR (within 6 months)
23
  43.4%
0
   0.0%
0
   0.0%
Confirmed CR+PR (within 9 months)
24
  45.3%
0
   0.0%
0
   0.0%
Confirmed CR+PR (12 months)
24
  45.3%
0
   0.0%
0
   0.0%
Unconfirmed CR+PR
26
  49.1%
0
   0.0%
0
   0.0%
Unconfirmed CR+PR (within 3 months)
20
  37.7%
0
   0.0%
0
   0.0%
Unconfirmed CR+PR (within 6 months)
25
  47.2%
0
   0.0%
0
   0.0%
Unconfirmed CR+PR (within 9 months)
25
  47.2%
0
   0.0%
0
   0.0%
Unconfirmed CR+PR (within 12 months)
25
  47.2%
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Number of Participants With Best Objective Response Based on Investigator (Confirmed and Unconfirmed) Following DS-8201a Treatment in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Advanced Colorectal Cancer
Hide Description Best objective response was reported based on investigator. As per Response Evaluation Criteria In Solid Tumors (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 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.
Time Frame Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 18 months post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Response was assessed in the Full Analysis Set.
Arm/Group Title DS-8201a Cohort A DS-8201a Cohort B DS-8201a Cohort C
Hide Arm/Group Description:
Participants in Cohort A were HER2-positive (IHC 3+ or IHC 2+/ISH +) who received DS-8201a once every 3 weeks.
Participants in Cohort B were HER2 IHC 2+/ISH - who received DS-8201a once every 3 weeks.
Participants in Cohort C were HER2/IHC 1+ who received DS-8201a once every 3 weeks.
Overall Number of Participants Analyzed 53 15 18
Measure Type: Count of Participants
Unit of Measure: Participants
Confirmed CR
0
   0.0%
0
   0.0%
0
   0.0%
Confirmed PR
25
  47.2%
0
   0.0%
0
   0.0%
Confirmed SD
18
  34.0%
7
  46.7%
6
  33.3%
Confirmed PD
6
  11.3%
7
  46.7%
8
  44.4%
Confirmed Non-evaluable
4
   7.5%
1
   6.7%
4
  22.2%
Unconfirmed CR
0
   0.0%
0
   0.0%
0
   0.0%
Unconfirmed PR
28
  52.8%
0
   0.0%
0
   0.0%
Unconfirmed SD
15
  28.3%
7
  46.7%
6
  33.3%
Unconfirmed PD
6
  11.3%
7
  46.7%
8
  44.4%
Unconfirmed Non-evaluable
4
   7.5%
1
   6.7%
4
  22.2%
4.Secondary Outcome
Title Number of Participants With Objective Response Rate Based on Investigator (Confirmed and Unconfirmed) Following DS-8201a Treatment in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Advanced Colorectal Cancer
Hide Description Objective response rate (defined as CR+PR) was reported based on investigator. As per Response Evaluation Criteria In Solid Tumors (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.
Time Frame Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 18 months post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Response was assessed in the Full Analysis Set.
Arm/Group Title DS-8201a Cohort A DS-8201a Cohort B DS-8201a Cohort C
Hide Arm/Group Description:
Participants in Cohort A were HER2-positive (IHC 3+ or IHC 2+/ISH +) who received DS-8201a once every 3 weeks.
Participants in Cohort B were HER2 IHC 2+/ISH - who received DS-8201a once every 3 weeks.
Participants in Cohort C were HER2/IHC 1+ who received DS-8201a once every 3 weeks.
Overall Number of Participants Analyzed 53 15 18
Measure Type: Count of Participants
Unit of Measure: Participants
Confirmed CR+PR
25
  47.2%
0
   0.0%
0
   0.0%
Unconfirmed CR+PR
28
  52.8%
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Duration of Response (Confirmed and Unconfirmed) Based on Independent Central Review Following DS-8201a Treatment in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Advanced Colorectal Cancer
Hide Description Duration of response (DoR) is defined as the time from the date of the first documentation of an objective response (CR[disappearance of all target lesions] or PR [at least a 30% decrease in the sum of diameters of target lesions]) to the date of the first documentation of PD (at least a 20% increase in the sum of diameters of target lesions). Duration of response was measured for responding participants (CR or PR) only. Month was calculated as (duration of response days × 12)/365.25 for duration of response and calculated as (time to response days × 12)/365.25 for time to response.
Time Frame Date of first documentation of objective response (CR or PR) up to date of first documentation of PD, up to approximately 18 months post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Duration of response was assessed only in Cohort A in the Full Analysis Set.
Arm/Group Title DS-8201a Cohort A
Hide Arm/Group Description:
Participants in Cohort A were HER2-positive (IHC 3+ or IHC 2+/ISH +) who received DS-8201a once every 3 weeks.
Overall Number of Participants Analyzed 53
Median (95% Confidence Interval)
Unit of Measure: months
Confirmed DoR Number Analyzed 24 participants
7.0
(5.8 to 9.5)
Unconfirmed DoR Number Analyzed 26 participants
7.0
(5.8 to 9.5)
6.Secondary Outcome
Title Disease Control Rate (Confirmed and Unconfirmed) Following DS-8201a Treatment in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Advanced Colorectal Cancer
Hide Description Disease control rate (DCR) was defined as the proportion of participants who achieved a best overall response of CR + PR + SD based on independent central review and investigator assessment. 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).
Time Frame Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 18 months post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Duration of response was assessed in the Full Analysis Set.
Arm/Group Title DS-8201a Cohort A DS-8201a Cohort B DS-8201a Cohort C
Hide Arm/Group Description:
Participants in Cohort A were HER2-positive (IHC 3+ or IHC 2+/ISH +) who received DS-8201a once every 3 weeks.
Participants in Cohort B were HER2 IHC 2+/ISH - who received DS-8201a once every 3 weeks.
Participants in Cohort C were HER2/IHC 1+ who received DS-8201a once every 3 weeks.
Overall Number of Participants Analyzed 53 15 18
Measure Type: Count of Participants
Unit of Measure: Participants
Confirmed CR+PR+SD (Independent Central Review)
44
  83.0%
9
  60.0%
4
  22.2%
Unconfirmed CR+PR+SD (Independent Central Review)
44
  83.0%
9
  60.0%
4
  22.2%
Confirmed CR+PR+SD (Investigator)
43
  81.1%
7
  46.7%
6
  33.3%
Unconfirmed CR+PR+SD (Investigator)
43
  81.1%
7
  46.7%
6
  33.3%
7.Secondary Outcome
Title Progression-Free Survival Based on Independent Central Review Following DS-8201a Treatment in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Advanced Colorectal Cancer
Hide Description Progression-free survival (PFS) is defined as the time from the date of the first dose to the earlier of the dates of the first objective documentation of radiographic progressive disease (PD) via independent radiologic facility review or death due to any cause. PD was defined as at least a 20% increase in the sum of diameters of target lesions.
Time Frame Date of first dose to date of first objective documentation of PD or death (whichever occurs first), up to approximately 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Progression-free survival was assessed in the Full Analysis Set.
Arm/Group Title DS-8201a Cohort A DS-8201a Cohort B DS-8201a Cohort C
Hide Arm/Group Description:
Participants in Cohort A were HER2-positive (IHC 3+ or IHC 2+/ISH +) who received DS-8201a once every 3 weeks.
Participants in Cohort B were HER2 IHC 2+/ISH - who received DS-8201a once every 3 weeks.
Participants in Cohort C were HER2/IHC 1+ who received DS-8201a once every 3 weeks.
Overall Number of Participants Analyzed 53 15 18
Median (95% Confidence Interval)
Unit of Measure: months
6.9
(4.1 to 8.7)
2.1
(1.4 to 4.1)
1.4
(1.3 to 2.1)
8.Secondary Outcome
Title Progression-Free Survival at Various Time Points Based on Independent Central Review Following DS-8201a Treatment in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Advanced Colorectal Cancer
Hide Description Progression-free survival (PFS) is defined as the time from the date of the first dose to the earlier of the dates of the first objective documentation of radiographic progressive disease (PD) via independent radiologic facility review or death due to any cause. PD was defined as at least a 20% increase in the sum of diameters of target lesions.Point estimates at 3, 6, 9, and 12 months are based on Kaplan-Meier estimate. CI is computed using the Brookmeyer-Crowley method. The point estimate percentage (95% confidence interval) at 3, 6, 9, and 12 months is being reported.
Time Frame Date of first dose to date of first objective documentation of PD or death (whichever occurs first), up to approximately 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Progression-free survival was assessed in the Full Analysis Set.
Arm/Group Title DS-8201a Cohort A DS-8201a Cohort B DS-8201a Cohort C
Hide Arm/Group Description:
Participants in Cohort A were HER2-positive (IHC 3+ or IHC 2+/ISH +) who received DS-8201a once every 3 weeks.
Participants in Cohort B were HER2 IHC 2+/ISH - who received DS-8201a once every 3 weeks.
Participants in Cohort C were HER2/IHC 1+ who received DS-8201a once every 3 weeks.
Overall Number of Participants Analyzed 53 15 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: point estimate percentage
Progression-free survival at 3 months
74.4
(60.0 to 84.3)
38.3
(13.0 to 63.6)
7.5
(0.5 to 28.3)
Progression-free survival at 6 months
55
(40.0 to 67.8)
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
Progression-free survival at 9 months
34.1
(19.7 to 49.1)
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
Progression-free survival at 12 months
19.0
(7.5 to 34.3)
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
[1]
Not enough events occurred to estimate the median time or confidence interval.
9.Secondary Outcome
Title Overall Survival Based on Independent Central Review Following DS-8201a Treatment in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Advanced Colorectal Cancer
Hide Description Overall survival (OS) is defined as the time from the date of first dose to the date of death from any cause.
Time Frame Time from the date of first dose to date of death from any cause, up to approximately 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Overall survival was assessed in Full Analysis Set.
Arm/Group Title DS-8201a Cohort A DS-8201a Cohort B DS-8201a Cohort C
Hide Arm/Group Description:
Participants in Cohort A were HER2-positive (IHC 3+ or IHC 2+/ISH +) who received DS-8201a once every 3 weeks.
Participants in Cohort B were HER2 IHC 2+/ISH - who received DS-8201a once every 3 weeks.
Participants in Cohort C were HER2/IHC 1+ who received DS-8201a once every 3 weeks.
Overall Number of Participants Analyzed 53 15 18
Median (95% Confidence Interval)
Unit of Measure: months
15.5
(8.8 to 20.8)
7.3 [1] 
(3.0 to NA)
7.7
(2.2 to 13.9)
[1]
Not enough events occurred to estimate the confidence interval.
10.Secondary Outcome
Title Overall Survival at Various Time Points Based on Independent Central Review Following DS-8201a Treatment in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Advanced Colorectal Cancer
Hide Description Overall survival (OS) is defined as the time from the date of first dose to the date of death from any cause. The point estimate percentage (95% confidence interval) at 3, 6, 9, and 12 months is being reported.
Time Frame Time from the date of first dose to date of death from any cause, up to approximately 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Overall survival was assessed in Full Analysis Set.
Arm/Group Title DS-8201a Cohort A DS-8201a Cohort B DS-8201a Cohort C
Hide Arm/Group Description:
Participants in Cohort A were HER2-positive (IHC 3+ or IHC 2+/ISH +) who received DS-8201a once every 3 weeks.
Participants in Cohort B were HER2 IHC 2+/ISH - who received DS-8201a once every 3 weeks.
Participants in Cohort C were HER2/IHC 1+ who received DS-8201a once every 3 weeks.
Overall Number of Participants Analyzed 53 15 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: point estimate percentage
Overall survival at 3 months
86.8
(74.3 to 93.5)
86.7
(56.4 to 96.5)
77.0
(49.7 to 90.7)
Overall survival at 6 months
73.6
(59.5 to 83.4)
53.3
(26.3 to 74.4)
57.8
(31.0 to 77.3)
Overall survival at 9 months
62.0
(47.5 to 73.5)
38.1
(14.6 to 61.6)
43.3
(18.9 to 65.7)
Overall survival at 12 months
60.0
(45.5 to 71.8)
38.1
(14.6 to 61.6)
28.9
(9.3 to 52.3)
11.Secondary Outcome
Title Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) Following Treatment With DS-8201a in Participants With HER2-expressing Advanced Colorectal Cancer
Hide Description Maximum serum concentration (Cmax) of DS-8201a and total anti-HER2 antibody was assessed.
Time Frame Cycle 1: Day 1, before infusion (BI), end of infusion (EOI); Day 8; Day 15; Cycle 2: Day 1, BI and EOI; Cycle 3: Day 1, BI, EOI, 4 hours after start of drug, and 7 hours after start of drug; Cycles 4 and 6: Day 1, BI and EOI
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic parameters were assessed Pharmacokinetic Analysis Set.
Arm/Group Title DS-8201a Cohort A DS-8201a Cohort B DS-8201a Cohort C
Hide Arm/Group Description:
Participants in Cohort A were HER2-positive (IHC 3+ or IHC 2+/ISH +) who received DS-8201a once every 3 weeks.
Participants in Cohort B were HER2 IHC 2+/ISH - who received DS-8201a once every 3 weeks.
Participants in Cohort C were HER2/IHC 1+ who received DS-8201a once every 3 weeks.
Overall Number of Participants Analyzed 53 15 18
Mean (Standard Deviation)
Unit of Measure: ug/mL
DS-8201a 135  (32.7) 123  (29.5) 122  (41.5)
Total anti-HER2 antibody 130  (35.1) 106  (24.6) 109  (35.4)
12.Secondary Outcome
Title Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) of MAAA-11181a Following Treatment With DS-8201a in Participants With HER2-expressing Advanced Colorectal Cancer
Hide Description Maximum serum concentration (Cmax) of MAAA-1181a was assessed.
Time Frame Cycle 1: Day 1, before infusion (BI), end of infusion (EOI); Day 8; Day 15; Cycle 2: Day 1, BI and EOI; Cycle 3: Day 1, BI, EOI, 4 hours after start of drug, and 7 hours after start of drug; Cycles 4 and 6: Day 1, BI and EOI
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Hide Analysis Population Description
Pharmacokinetic parameters were assessed Pharmacokinetic Analysis Set.
Arm/Group Title DS-8201a Cohort A DS-8201a Cohort B DS-8201a Cohort C
Hide Arm/Group Description:
Participants in Cohort A were HER2-positive (IHC 3+ or IHC 2+/ISH +) who received DS-8201a once every 3 weeks.
Participants in Cohort B were HER2 IHC 2+/ISH - who received DS-8201a once every 3 weeks.
Participants in Cohort C were HER2/IHC 1+ who received DS-8201a once every 3 weeks.
Overall Number of Participants Analyzed 53 15 18
Mean (Standard Deviation)
Unit of Measure: ng/mL
15.8  (7.67) 12.9  (6.40) 15.1  (5.30)
13.Secondary Outcome
Title Pharmacokinetic Parameter Time to Maximum Serum Concentration (Tmax) Following Treatment With DS-8201a in Participants With HER2-expressing Advanced Colorectal Cancer
Hide Description Time to maximum serum concentration (Tmax) of DS-8201a, total anti-HER2 antibody, and MAAA-1181a was assessed.
Time Frame Cycle 1: Day 1, before infusion (BI), end of infusion (EOI); Day 8; Day 15; Cycle 2: Day 1, BI and EOI; Cycle 3: Day 1, BI, EOI, 4 hours after start of drug, and 7 hours after start of drug; Cycles 4 and 6: Day 1, BI and EOI
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic parameters were assessed Pharmacokinetic Analysis Set.
Arm/Group Title DS-8201a Cohort A DS-8201a Cohort B DS-8201a Cohort C
Hide Arm/Group Description:
Participants in Cohort A were HER2-positive (IHC 3+ or IHC 2+/ISH +) who received DS-8201a once every 3 weeks.
Participants in Cohort B were HER2 IHC 2+/ISH - who received DS-8201a once every 3 weeks.
Participants in Cohort C were HER2/IHC 1+ who received DS-8201a once every 3 weeks.
Overall Number of Participants Analyzed 53 15 18
Median (Full Range)
Unit of Measure: hours
DS-8201a
1.95
(1.42 to 8.75)
1.72
(1.25 to 5.08)
3.00
(0.88 to 6.92)
Total anti-HER2 antibody
1.72
(1.42 to 6.95)
1.68
(1.25 to 7.08)
1.93
(0.88 to 6.92)
MAAA-1181a
5.17
(1.75 to 8.75)
5.00
(3.83 to 6.97)
5.25
(3.83 to 7.00)
14.Secondary Outcome
Title Pharmacokinetic Parameter Area Under the Concentration-time Curve (AUC) Following Treatment With DS-8201a in Participants With HER2-expressing Advanced Colorectal Cancer
Hide Description Area under the concentration-time curve (AUC) from dosing until 21 days (AUC21d) and the last quantifiable concentration (AUClast) of DS-8201a and total anti-HER2 antibody were assessed.
Time Frame Cycle 1: Day 1, before infusion (BI), end of infusion (EOI); Day 8; Day 15; Cycle 2: Day 1, BI and EOI; Cycle 3: Day 1, BI, EOI, 4 hours after start of drug, and 7 hours after start of drug; Cycles 4 and 6: Day 1, BI and EOI
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Hide Analysis Population Description
Pharmacokinetic parameters were assessed Pharmacokinetic Analysis Set.
Arm/Group Title DS-8201a Cohort A DS-8201a Cohort B DS-8201a Cohort C
Hide Arm/Group Description:
Participants in Cohort A were HER2-positive (IHC 3+ or IHC 2+/ISH +) who received DS-8201a once every 3 weeks.
Participants in Cohort B were HER2 IHC 2+/ISH - who received DS-8201a once every 3 weeks.
Participants in Cohort C were HER2/IHC 1+ who received DS-8201a once every 3 weeks.
Overall Number of Participants Analyzed 53 15 18
Mean (Standard Deviation)
Unit of Measure: ug*d/mL
DS-8201a: AUC21d Number Analyzed 51 participants 13 participants 16 participants
610  (198) 571  (208) 577  (219)
DS-8201a: AUClast Number Analyzed 53 participants 15 participants 18 participants
600  (204) 559  (211) 577  (237)
Total anti-HER2 antibody: AUC21d Number Analyzed 50 participants 13 participants 16 participants
661  (218) 569  (224) 574  (219)
Total anti-HER2 antibody: AUClast Number Analyzed 53 participants 15 participants 18 participants
638  (235) 558  (225) 555  (224)
15.Secondary Outcome
Title Pharmacokinetic Parameter Area Under the Concentration-time Curve (AUC) of MAAA-1181a Following Treatment With DS-8201a in Participants With HER2-expressing Advanced Colorectal Cancer
Hide Description Area under the concentration-time curve (AUC) from dosing until 21 days (AUC21d) and the last quantifiable concentration (AUClast) of MAAA-1181a were assessed.
Time Frame Cycle 1: Day 1, before infusion (BI), end of infusion (EOI); Day 8; Day 15; Cycle 2: Day 1, BI and EOI; Cycle 3: Day 1, BI, EOI, 4 hours after start of drug, and 7 hours after start of drug; Cycles 4 and 6: Day 1, BI and EOI
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic parameters were assessed Pharmacokinetic Analysis Set.
Arm/Group Title DS-8201a Cohort A DS-8201a Cohort B DS-8201a Cohort C
Hide Arm/Group Description:
Participants in Cohort A were HER2-positive (IHC 3+ or IHC 2+/ISH +) who received DS-8201a once every 3 weeks.
Participants in Cohort B were HER2 IHC 2+/ISH - who received DS-8201a once every 3 weeks.
Participants in Cohort C were HER2/IHC 1+ who received DS-8201a once every 3 weeks.
Overall Number of Participants Analyzed 53 15 18
Mean (Standard Deviation)
Unit of Measure: ng*d/mL
MAAA-1181a: AUC21d Number Analyzed 45 participants 12 participants 11 participants
60.2  (42.7) 45.0  (28.1) 55.1  (19.6)
MAAA-1181a: AUClast Number Analyzed 53 participants 15 participants 18 participants
59.5  (42.1) 47.1  (29.4) 62.5  (19.6)
16.Secondary Outcome
Title Treatment-Emergent Adverse Events (TEAEs) Reported By ≥20% Of Participants Following Treatment With DS-8201a in Participants With HER2-expressing Advanced Colorectal Cancer
Hide Description A treatment-emergent adverse event (TEAE) is defined as any adverse event not present prior to the initiation of drug treatment or any adverse event already present that worsens in intensity or frequency following exposure to the drug treatment. TEAEs were graded using National Cancer Institute (NCI)-CTCAE version 4.03.
Time Frame From the date of signing the informed consent form up to 40 (+7) days after last dose, up to approximately 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Adverse events were assessed in the Safety Analysis Set.
Arm/Group Title DS-8201a Cohort A DS-8201a Cohort B DS-8201a Cohort C
Hide Arm/Group Description:
Participants in Cohort A were HER2-positive (IHC 3+ or IHC 2+/ISH +) who received DS-8201a once every 3 weeks.
Participants in Cohort B were HER2 IHC 2+/ISH - who received DS-8201a once every 3 weeks.
Participants in Cohort C were HER2/IHC 1+ who received DS-8201a once every 3 weeks.
Overall Number of Participants Analyzed 53 15 18
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
53
 100.0%
15
 100.0%
18
 100.0%
Nausea
37
  69.8%
9
  60.0%
7
  38.9%
Anaemia
21
  39.6%
4
  26.7%
6
  33.3%
Decreased appetite
18
  34.0%
5
  33.3%
7
  38.9%
Fatigue
21
  39.6%
7
  46.7%
3
  16.7%
Neutrophil count decreased
20
  37.7%
2
  13.3%
4
  22.2%
Platelet count decreased
17
  32.1%
4
  26.7%
7
  38.9%
Vomiting
23
  43.4%
3
  20.0%
1
   5.6%
Diarrhoea
19
  35.8%
0
   0.0%
4
  22.2%
Alopecia
12
  22.6%
4
  26.7%
1
   5.6%
Constipation
10
  18.9%
3
  20.0%
1
   5.6%
Hypokalaemia
9
  17.0%
1
   6.7%
4
  22.2%
Aspartate aminotransferase increased
6
  11.3%
1
   6.7%
4
  22.2%
Malaise
5
   9.4%
0
   0.0%
4
  22.2%
Interstitial lung disease
4
   7.5%
3
  20.0%
1
   5.6%
Dyspnoea
3
   5.7%
3
  20.0%
0
   0.0%
Time Frame Adverse events were collected from the date of signing the informed consent form up to 40 (+7) days after last dose, up to approximately 18 months.
Adverse Event Reporting Description A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or having worsened in severity or seriousness after initiation of the study drug until 40 (+7) days after the last dose of the study drug.
 
Arm/Group Title DS-8201a Cohort A DS-8201a Cohort B DS-8201a Cohort C
Hide Arm/Group Description Participants in Cohort A were HER2-positive (IHC 3+ or IHC 2+/ISH +) who received DS-8201a once every 3 weeks. Participants in Cohort B were HER2 IHC 2+/ISH - who received DS-8201a once every 3 weeks. Participants in Cohort C were HER2/IHC 1+ who received DS-8201a once every 3 weeks.
All-Cause Mortality
DS-8201a Cohort A DS-8201a Cohort B DS-8201a Cohort C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   36/53 (67.92%)   10/15 (66.67%)   12/18 (66.67%) 
Hide Serious Adverse Events
DS-8201a Cohort A DS-8201a Cohort B DS-8201a Cohort C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   20/53 (37.74%)   6/15 (40.00%)   9/18 (50.00%) 
Blood and lymphatic system disorders       
Anaemia  2  2/53 (3.77%)  0/15 (0.00%)  0/18 (0.00%) 
Gastrointestinal disorders       
Diarrhoea  2  2/53 (3.77%)  0/15 (0.00%)  1/18 (5.56%) 
Nausea  2  2/53 (3.77%)  1/15 (6.67%)  0/18 (0.00%) 
Gastritis  2  1/53 (1.89%)  0/15 (0.00%)  0/18 (0.00%) 
Gastrointestinal ulcer  2  1/53 (1.89%)  0/15 (0.00%)  0/18 (0.00%) 
Ileus  2  1/53 (1.89%)  0/15 (0.00%)  0/18 (0.00%) 
Ileus paralytic  2  0/53 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Vomiting  2  1/53 (1.89%)  0/15 (0.00%)  0/18 (0.00%) 
Intestinal obstruction  2  0/53 (0.00%)  1/15 (6.67%)  0/18 (0.00%) 
Small intestinal obstruction  1  0/53 (0.00%)  1/15 (6.67%)  0/18 (0.00%) 
General disorders       
Disease progression  2  1/53 (1.89%)  0/15 (0.00%)  1/18 (5.56%) 
Pyrexia  2  1/53 (1.89%)  0/15 (0.00%)  1/18 (5.56%) 
Fatigue  2  1/53 (1.89%)  0/15 (0.00%)  0/18 (0.00%) 
General physical health deterioration  2  0/53 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Hepatobiliary disorders       
Bile duct stenosis  2  1/53 (1.89%)  0/15 (0.00%)  0/18 (0.00%) 
Bile duct obstruction  2  0/53 (0.00%)  1/15 (6.67%)  0/18 (0.00%) 
Cholecystitis  2  0/53 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Infections and infestations       
Sepsis  1  3/53 (5.66%)  0/15 (0.00%)  1/18 (5.56%) 
Urinary tract infection  2  2/53 (3.77%)  0/15 (0.00%)  0/18 (0.00%) 
Infected fistula  2  1/53 (1.89%)  0/15 (0.00%)  0/18 (0.00%) 
Lung infection  2  1/53 (1.89%)  0/15 (0.00%)  0/18 (0.00%) 
Pneumonia klebsiella  2  1/53 (1.89%)  0/15 (0.00%)  0/18 (0.00%) 
Abdominal sepsis  2  0/53 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Pneumonia  2  1/53 (1.89%)  0/15 (0.00%)  0/18 (0.00%) 
Injury, poisoning and procedural complications       
Gastrointestinal stoma complication  2  0/53 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Femoral neck fracture  1  1/53 (1.89%)  0/15 (0.00%)  0/18 (0.00%) 
Investigations       
Neutrophil count decreased  2  2/53 (3.77%)  0/15 (0.00%)  0/18 (0.00%) 
Platelet count decreased  2  1/53 (1.89%)  0/15 (0.00%)  0/18 (0.00%) 
Metabolism and nutrition disorders       
Hypokalaemia  2  1/53 (1.89%)  0/15 (0.00%)  0/18 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Cancer pain  2  0/53 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Nervous system disorders       
Meningism  2  1/53 (1.89%)  0/15 (0.00%)  0/18 (0.00%) 
Seizure  2  1/53 (1.89%)  0/15 (0.00%)  0/18 (0.00%) 
Renal and urinary disorders       
Hydronephrosis  2  2/53 (3.77%)  0/15 (0.00%)  1/18 (5.56%) 
Acute kidney injury  2  0/53 (0.00%)  1/15 (6.67%)  1/18 (5.56%) 
Respiratory, thoracic and mediastinal disorders       
Interstitial lung disease  2  1/53 (1.89%)  2/15 (13.33%)  1/18 (5.56%) 
Pneumonitis  2  2/53 (3.77%)  0/15 (0.00%)  0/18 (0.00%) 
Dyspnoea  2  0/53 (0.00%)  1/15 (6.67%)  0/18 (0.00%) 
1
Term from vocabulary, MedDRA 20.0
2
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%
DS-8201a Cohort A DS-8201a Cohort B DS-8201a Cohort C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   53/53 (100.00%)   15/15 (100.00%)   18/18 (100.00%) 
Blood and lymphatic system disorders       
Anaemia  2  21/53 (39.62%)  4/15 (26.67%)  6/18 (33.33%) 
Neutropenia  2  5/53 (9.43%)  0/15 (0.00%)  1/18 (5.56%) 
Thrombocytopenia  2  0/53 (0.00%)  0/15 (0.00%)  2/18 (11.11%) 
Leukocytosis  2  0/53 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Eye disorders       
Eye pain  2  0/53 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Keratitis  2  0/53 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Dry eye  2  5/53 (9.43%)  0/15 (0.00%)  0/18 (0.00%) 
Gastrointestinal disorders       
Nausea  1  37/53 (69.81%)  9/15 (60.00%)  7/18 (38.89%) 
Vomiting  2  23/53 (43.40%)  3/15 (20.00%)  1/18 (5.56%) 
Diarrhoea  2  19/53 (35.85%)  0/15 (0.00%)  4/18 (22.22%) 
Constipation  2  10/53 (18.87%)  3/15 (20.00%)  1/18 (5.56%) 
Stomatitis  2  6/53 (11.32%)  2/15 (13.33%)  1/18 (5.56%) 
Abdominal pain  2  8/53 (15.09%)  2/15 (13.33%)  0/18 (0.00%) 
Abdominal pain upper  2  3/53 (5.66%)  1/15 (6.67%)  0/18 (0.00%) 
Gastritis  1  3/53 (5.66%)  0/15 (0.00%)  0/18 (0.00%) 
Ascites  2  0/53 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Gastrointestinal stoma complication  2  0/53 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Haemorrhoids  2  0/53 (0.00%)  1/15 (6.67%)  1/18 (5.56%) 
Ileus paralytic  2  0/53 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Intestinal prolapse  2  0/53 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Small intestinal obstruction  1  1/53 (1.89%)  1/15 (6.67%)  0/18 (0.00%) 
Abdominal sepsis  1  0/53 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Intestinal obstruction  1  0/53 (0.00%)  1/15 (6.67%)  0/18 (0.00%) 
General disorders       
Fatigue  2  21/53 (39.62%)  7/15 (46.67%)  3/18 (16.67%) 
Asthenia  2  6/53 (11.32%)  2/15 (13.33%)  3/18 (16.67%) 
Oedema peripheral  2  8/53 (15.09%)  1/15 (6.67%)  1/18 (5.56%) 
Pyrexia  2  8/53 (15.09%)  1/15 (6.67%)  3/18 (16.67%) 
Malaise  2  5/53 (9.43%)  0/15 (0.00%)  4/18 (22.22%) 
Disease progression  2  1/53 (1.89%)  0/15 (0.00%)  1/18 (5.56%) 
General physical health deterioration  2  0/53 (0.00%)  0/15 (0.00%)  2/18 (11.11%) 
Generalised oedema  2  0/53 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Oedema  2  0/53 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Fluid retention  1  0/53 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Hepatobiliary disorders       
Bile duct obstruction  1  0/53 (0.00%)  1/15 (6.67%)  0/18 (0.00%) 
Cholecystitis  1  0/53 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Infections and infestations       
Sepsis  2  3/53 (5.66%)  0/15 (0.00%)  1/18 (5.56%) 
Urinary tract infection  2  5/53 (9.43%)  1/15 (6.67%)  1/18 (5.56%) 
Cystitis  2  4/53 (7.55%)  0/15 (0.00%)  0/18 (0.00%) 
Lung infection  2  1/53 (1.89%)  1/15 (6.67%)  0/18 (0.00%) 
Fungal infection  2  0/53 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Oral herpes  2  0/53 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Influenza  1  1/53 (1.89%)  1/15 (6.67%)  0/18 (0.00%) 
Oral candidiasis  1  1/53 (1.89%)  1/15 (6.67%)  0/18 (0.00%) 
Pneumonia  1  1/53 (1.89%)  1/15 (6.67%)  0/18 (0.00%) 
Pneumonia bacterial  1  0/53 (0.00%)  1/15 (6.67%)  0/18 (0.00%) 
Investigations       
Neutrophil count decreased  2  20/53 (37.74%)  2/15 (13.33%)  4/18 (22.22%) 
Platelet count decreased  2  17/53 (32.08%)  4/15 (26.67%)  7/18 (38.89%) 
White blood cell count decreased  2  11/53 (20.75%)  1/15 (6.67%)  2/18 (11.11%) 
Aspartate aminotransferase increased  2  6/53 (11.32%)  1/15 (6.67%)  4/18 (22.22%) 
Alanine aminotransferase increased  2  5/53 (9.43%)  1/15 (6.67%)  3/18 (16.67%) 
Blood creatinine increased  2  5/53 (9.43%)  0/15 (0.00%)  2/18 (11.11%) 
Weight decreased  2  5/53 (9.43%)  0/15 (0.00%)  1/18 (5.56%) 
Blood alkaline phosphatase increased  2  3/53 (5.66%)  1/15 (6.67%)  1/18 (5.56%) 
Blood bilirubin increased  2  3/53 (5.66%)  1/15 (6.67%)  2/18 (11.11%) 
Blood lactate dehydrogenase increased  2  2/53 (3.77%)  0/15 (0.00%)  2/18 (11.11%) 
Haemoglobin decreased  2  3/53 (5.66%)  0/15 (0.00%)  0/18 (0.00%) 
Lymphocyte count decreased  2  2/53 (3.77%)  2/15 (13.33%)  0/18 (0.00%) 
Blood calcium decreased  2  0/53 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Blood potassium decreased  2  0/53 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Blood magnesium decreased  1  2/53 (3.77%)  1/15 (6.67%)  0/18 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite  2  18/53 (33.96%)  5/15 (33.33%)  7/18 (38.89%) 
Hypokalaemia  2  9/53 (16.98%)  1/15 (6.67%)  4/18 (22.22%) 
Hypomagnesaemia  2  4/53 (7.55%)  1/15 (6.67%)  1/18 (5.56%) 
Hypoalbuminaemia  2  2/53 (3.77%)  0/15 (0.00%)  2/18 (11.11%) 
Hypocalcaemia  2  2/53 (3.77%)  0/15 (0.00%)  1/18 (5.56%) 
Cachexia  2  0/53 (0.00%)  1/15 (6.67%)  1/18 (5.56%) 
Dehydration  2  1/53 (1.89%)  0/15 (0.00%)  1/18 (5.56%) 
Hypercalcaemia  2  0/53 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Hyperuricaemia  2  0/53 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Hyponatraemia  2  0/53 (0.00%)  1/15 (6.67%)  1/18 (5.56%) 
Musculoskeletal and connective tissue disorders       
Back pain  2  5/53 (9.43%)  0/15 (0.00%)  0/18 (0.00%) 
Arthralgia  2  3/53 (5.66%)  0/15 (0.00%)  0/18 (0.00%) 
Myalgia  2  3/53 (5.66%)  0/15 (0.00%)  0/18 (0.00%) 
Musculoskeletal pain  1  2/53 (3.77%)  2/15 (13.33%)  0/18 (0.00%) 
Proctalgia  1  0/53 (0.00%)  1/15 (6.67%)  0/18 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Cancer pain  2  1/53 (1.89%)  0/15 (0.00%)  1/18 (5.56%) 
Nervous system disorders       
Dysgeusia  2  4/53 (7.55%)  1/15 (6.67%)  1/18 (5.56%) 
Paraesthesia  2  2/53 (3.77%)  0/15 (0.00%)  1/18 (5.56%) 
Headache  1  2/53 (3.77%)  1/15 (6.67%)  0/18 (0.00%) 
Vasogenic cerebral oedema  1  0/53 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Psychiatric disorders       
Insomnia  1  3/53 (5.66%)  1/15 (6.67%)  1/18 (5.56%) 
Mood altered  2  0/53 (0.00%)  1/15 (6.67%)  0/18 (0.00%) 
Renal and urinary disorders       
Hydronephrosis  2  2/53 (3.77%)  0/15 (0.00%)  1/18 (5.56%) 
Acute kidney injury  2  2/53 (3.77%)  1/15 (6.67%)  1/18 (5.56%) 
Pollakiuria  2  1/53 (1.89%)  0/15 (0.00%)  1/18 (5.56%) 
Dysuria  1  0/53 (0.00%)  1/15 (6.67%)  0/18 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  2  8/53 (15.09%)  2/15 (13.33%)  0/18 (0.00%) 
Dyspnoea  2  3/53 (5.66%)  3/15 (20.00%)  0/18 (0.00%) 
Interstitial lung disease  2  4/53 (7.55%)  3/15 (20.00%)  1/18 (5.56%) 
Productive cough  2  3/53 (5.66%)  0/15 (0.00%)  0/18 (0.00%) 
Upper respiratory tract infection  2  2/53 (3.77%)  1/15 (6.67%)  0/18 (0.00%) 
Skin and subcutaneous tissue disorders       
Alopecia  2  12/53 (22.64%)  4/15 (26.67%)  1/18 (5.56%) 
Flushing  1  0/53 (0.00%)  1/15 (6.67%)  0/18 (0.00%) 
Jaundice  1  0/53 (0.00%)  1/15 (6.67%)  0/18 (0.00%) 
Vascular disorders       
Hypertension  2  3/53 (5.66%)  0/15 (0.00%)  1/18 (5.56%) 
Hypotension  2  0/53 (0.00%)  0/15 (0.00%)  2/18 (11.11%) 
Retinal vein occlusion  1  0/53 (0.00%)  1/15 (6.67%)  0/18 (0.00%) 
1
Term from vocabulary, MedDRA 20.0
2
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 Sanyko, Inc.
Phone: 908-992-6400
EMail: CTRinfo@dsi.com
Layout table for additonal information
Responsible Party: Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )
ClinicalTrials.gov Identifier: NCT03384940    
Other Study ID Numbers: DS8201-A-J203
2017-003466-28 ( EudraCT Number )
173808 ( Registry Identifier: JAPIC CTI )
DESTINY-C01 ( Other Identifier: Daiichi Sankyo and AstraZeneca )
First Submitted: December 20, 2017
First Posted: December 28, 2017
Results First Submitted: May 12, 2021
Results First Posted: August 24, 2021
Last Update Posted: August 24, 2021