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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003466-28 | EudraCT Number | ||
| 173808 | Registry Identifier | JAPIC CTI | |
| DESTINY-C01 | Other Identifier | Daiichi Sankyo and AstraZeneca |
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| Name | Class |
|---|---|
| Daiichi Sankyo | INDUSTRY |
| AstraZeneca | INDUSTRY |
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The main objective of this study is to test the safety and effectiveness of DS-8201a for participants with HER2-expressing advanced colorectal cancer.
At study start, only Cohort A is active.
If, and when, Cohort B and C become active depends on the assessment of benefit and risk observed in the program.
The sponsor will inform the investigators if, and when, Cohort B and C are active.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DS-8201a Cohort A | Experimental | Cohort A is comprised of participants with HER2-positive (IHC 3+ or IHC 2+/ISH +) who will receive DS-8201a once every 3 weeks |
|
| DS-8201a Cohort B | Experimental | Cohort B is comprised of participants with HER2 IHC 2+/ISH - who will receive DS-8201a once every 3 weeks |
|
| DS-8201a Cohort C | Experimental | Cohort C is comprised of participants with HER2 IHC 1+ who will receive DS-8201a once every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DS-8201a | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 18 months post-dose |
| 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 | 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. | Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 18 months post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States | ||
| University of Southern California |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39587050 | Derived | Siena S, Raghav K, Masuishi T, Yamaguchi K, Nishina T, Elez E, Rodriguez J, Chau I, Di Bartolomeo M, Kawakami H, Suto F, Koga M, Inaki K, Kuwahara Y, Takehara I, Barrios D, Kobayashi K, Grothey A, Yoshino T. HER2-related biomarkers predict clinical outcomes with trastuzumab deruxtecan treatment in patients with HER2-expressing metastatic colorectal cancer: biomarker analyses of DESTINY-CRC01. Nat Commun. 2024 Nov 25;15(1):10213. doi: 10.1038/s41467-024-53223-3. | |
| 37286557 |
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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/
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.
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.
After tissue screening, a total of 86 participants were eligible based on confirmation of HER2 status.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | DS-8201a Cohort A | Participants in Cohort A were HER2-positive (IHC 3+ or IHC 2+/ISH +) who received DS-8201a once every 3 weeks. |
| FG001 | DS-8201a Cohort B | Participants in Cohort B were HER2 IHC 2+/ISH - who received DS-8201a once every 3 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 3, 2020 |
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|
| Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 18 months post-dose |
| 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 | 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. | Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 18 months post-dose |
| 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 | 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. | 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 |
| Disease Control Rate (Confirmed and Unconfirmed) Following DS-8201a Treatment in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Advanced Colorectal Cancer | 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). | Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 18 months post-dose |
| 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 | 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. | Date of first dose to date of first objective documentation of PD or death (whichever occurs first), up to approximately 18 months |
| 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 | 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. | Date of first dose to date of first objective documentation of PD or death (whichever occurs first), up to approximately 18 months |
| 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 | Overall survival (OS) is defined as the time from the date of first dose to the date of death from any cause. | Time from the date of first dose to date of death from any cause, up to approximately 18 months |
| 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 | 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 from the date of first dose to date of death from any cause, up to approximately 18 months |
| Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) Following Treatment With DS-8201a in Participants With HER2-expressing Advanced Colorectal Cancer | Maximum serum concentration (Cmax) of DS-8201a and total anti-HER2 antibody was assessed. | 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 |
| Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) of MAAA-11181a Following Treatment With DS-8201a in Participants With HER2-expressing Advanced Colorectal Cancer | Maximum serum concentration (Cmax) of MAAA-1181a was assessed. | 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 |
| Pharmacokinetic Parameter Time to Maximum Serum Concentration (Tmax) Following Treatment With DS-8201a in Participants With HER2-expressing Advanced Colorectal Cancer | Time to maximum serum concentration (Tmax) of DS-8201a, total anti-HER2 antibody, and MAAA-1181a was assessed. | 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 |
| Pharmacokinetic Parameter Area Under the Concentration-time Curve (AUC) Following Treatment With DS-8201a in Participants With HER2-expressing Advanced Colorectal Cancer | 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. | 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 |
| 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 | Area under the concentration-time curve (AUC) from dosing until 21 days (AUC21d) and the last quantifiable concentration (AUClast) of MAAA-1181a were assessed. | 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 |
| Treatment-Emergent Adverse Events (TEAEs) Reported By ≥20% Of Participants Following Treatment With DS-8201a in Participants With HER2-expressing Advanced Colorectal Cancer | 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. | From the date of signing the informed consent form up to 40 (+7) days after last dose, up to approximately 18 months |
| Los Angeles |
| California |
| 90089 |
| United States |
| UCLA Health | Santa Monica | California | 90404 | United States |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224-1865 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Greenville Health System Cancer Institute | Greenville | South Carolina | 29605-4255 | United States |
| West Cancer Center | Germantown | Tennessee | 38138 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| MD Anderson Cancer Center, University of Texas | Houston | Texas | 77030-4000 | United States |
| Università degli studi della Campania L.Vanvitelli | Naples | Campania | 80131 | Italy |
| Oncology Institute Veneto IOV-IRCCS | Padova | Ferrara | 35128 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda | Milan | Lombardo | 20162 | Italy |
| Fondazione IRCCS - Istituto Nazionale dei Tumori | Milan | 20133 | Italy |
| Aichi Cancer Center Hospital | Nagoya | Aichi-ken | 464-8681 | Japan |
| National Cancer Center Hospital East | Kashiwa | Chiba | 277-8577 | Japan |
| National Hospital Organization Shikoku Cancer Center | Matsuyama | Ehime | 791-0280 | Japan |
| Hokkaido University Hospital | Sapporo | Hokkaido | 060-8648 | Japan |
| Kindai University Hospital | Ōsaka-sayama | Osaka | 589-8511 | Japan |
| The Cancer Institute Hospital of Japanese Foundation for Cancer Research | Koto-Ku | Tokyo | 135-8550 | Japan |
| National Hospital Organization Kyushu Cancer Center | Fukuoka | 811-1395 | Japan |
| Clinica Universidad de Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitari Clinic de Barcelona | Barcelona | 08036 | Spain |
| Royal Marsden Institute (Chelsea) | Chelsea | London, England | SM2 5PT | United Kingdom |
| Royal Marsden Institute (Sutton) | Sutton | Surrey, England | SW3 6JJ | United Kingdom |
| Derived |
| Yoshino T, Di Bartolomeo M, Raghav K, Masuishi T, Loupakis F, Kawakami H, Yamaguchi K, Nishina T, Wainberg Z, Elez E, Rodriguez J, Fakih M, Ciardiello F, Saxena K, Kobayashi K, Bako E, Okuda Y, Meinhardt G, Grothey A, Siena S; DESTINY-CRC01 investigators. Final results of DESTINY-CRC01 investigating trastuzumab deruxtecan in patients with HER2-expressing metastatic colorectal cancer. Nat Commun. 2023 Jun 7;14(1):3332. doi: 10.1038/s41467-023-38032-4. |
| 33961795 | Derived | Siena S, Di Bartolomeo M, Raghav K, Masuishi T, Loupakis F, Kawakami H, Yamaguchi K, Nishina T, Fakih M, Elez E, Rodriguez J, Ciardiello F, Komatsu Y, Esaki T, Chung K, Wainberg Z, Sartore-Bianchi A, Saxena K, Yamamoto E, Bako E, Okuda Y, Shahidi J, Grothey A, Yoshino T; DESTINY-CRC01 investigators. Trastuzumab deruxtecan (DS-8201) in patients with HER2-expressing metastatic colorectal cancer (DESTINY-CRC01): a multicentre, open-label, phase 2 trial. Lancet Oncol. 2021 Jun;22(6):779-789. doi: 10.1016/S1470-2045(21)00086-3. Epub 2021 May 4. |
| FG002 | DS-8201a Cohort C | Participants in Cohort C were HER2/IHC 1+ who received DS-8201a once every 3 weeks. |
| COMPLETED | As of database lock for final analysis on 28 Dec 2020 |
|
| NOT COMPLETED |
|
|
The baseline demographic characteristics were derived from the Full Analysis Set.
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| ID | Title | Description |
|---|---|---|
| BG000 | DS-8201a Cohort A | Participants in Cohort A were HER2-positive (IHC 3+ or IHC 2+/ISH +) who received DS-8201a once every 3 weeks. |
| BG001 | DS-8201a Cohort B | Participants in Cohort B were HER2 IHC 2+/ISH - who received DS-8201a once every 3 weeks. |
| BG002 | DS-8201a Cohort C | Participants in Cohort C were HER2/IHC 1+ who received DS-8201a once every 3 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | Response was assessed in the Full Analysis Set. | Posted | Count of Participants | Participants | Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 18 months post-dose |
|
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| Primary | 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 | 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. | Response was assessed in the Full Analysis Set. | Posted | Count of Participants | Participants | Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 18 months post-dose |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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 | 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. | Response was assessed in the Full Analysis Set. | Posted | Count of Participants | Participants | Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 18 months post-dose |
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| Secondary | 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 | 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. | Response was assessed in the Full Analysis Set. | Posted | Count of Participants | Participants | Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 18 months post-dose |
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| Secondary | 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 | 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. | Duration of response was assessed only in Cohort A in the Full Analysis Set. | Posted | Median | 95% Confidence Interval | months | 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 |
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| Secondary | Disease Control Rate (Confirmed and Unconfirmed) Following DS-8201a Treatment in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Advanced Colorectal Cancer | 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). | Duration of response was assessed in the Full Analysis Set. | Posted | Count of Participants | Participants | Baseline up to withdrawal of consent, progressive disease, or unacceptable toxicity (whichever occurs first), up to 18 months post-dose |
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| Secondary | 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 | 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. | Progression-free survival was assessed in the Full Analysis Set. | Posted | Median | 95% Confidence Interval | months | Date of first dose to date of first objective documentation of PD or death (whichever occurs first), up to approximately 18 months |
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| Secondary | 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 | 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. | Progression-free survival was assessed in the Full Analysis Set. | Posted | Number | 95% Confidence Interval | point estimate percentage | Date of first dose to date of first objective documentation of PD or death (whichever occurs first), up to approximately 18 months |
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| Secondary | 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 | Overall survival (OS) is defined as the time from the date of first dose to the date of death from any cause. | Overall survival was assessed in Full Analysis Set. | Posted | Median | 95% Confidence Interval | months | Time from the date of first dose to date of death from any cause, up to approximately 18 months |
|
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| Secondary | 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 | 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. | Overall survival was assessed in Full Analysis Set. | Posted | Number | 95% Confidence Interval | point estimate percentage | Time from the date of first dose to date of death from any cause, up to approximately 18 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) Following Treatment With DS-8201a in Participants With HER2-expressing Advanced Colorectal Cancer | Maximum serum concentration (Cmax) of DS-8201a and total anti-HER2 antibody was assessed. | Pharmacokinetic parameters were assessed Pharmacokinetic Analysis Set. | Posted | Mean | Standard Deviation | ug/mL | 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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| Secondary | Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) of MAAA-11181a Following Treatment With DS-8201a in Participants With HER2-expressing Advanced Colorectal Cancer | Maximum serum concentration (Cmax) of MAAA-1181a was assessed. | Pharmacokinetic parameters were assessed Pharmacokinetic Analysis Set. | Posted | Mean | Standard Deviation | ng/mL | 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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| Secondary | Pharmacokinetic Parameter Time to Maximum Serum Concentration (Tmax) Following Treatment With DS-8201a in Participants With HER2-expressing Advanced Colorectal Cancer | Time to maximum serum concentration (Tmax) of DS-8201a, total anti-HER2 antibody, and MAAA-1181a was assessed. | Pharmacokinetic parameters were assessed Pharmacokinetic Analysis Set. | Posted | Median | Full Range | hours | 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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| Secondary | Pharmacokinetic Parameter Area Under the Concentration-time Curve (AUC) Following Treatment With DS-8201a in Participants With HER2-expressing Advanced Colorectal Cancer | 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. | Pharmacokinetic parameters were assessed Pharmacokinetic Analysis Set. | Posted | Mean | Standard Deviation | ug*d/mL | 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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| Secondary | 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 | Area under the concentration-time curve (AUC) from dosing until 21 days (AUC21d) and the last quantifiable concentration (AUClast) of MAAA-1181a were assessed. | Pharmacokinetic parameters were assessed Pharmacokinetic Analysis Set. | Posted | Mean | Standard Deviation | ng*d/mL | 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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| Secondary | Treatment-Emergent Adverse Events (TEAEs) Reported By ≥20% Of Participants Following Treatment With DS-8201a in Participants With HER2-expressing Advanced Colorectal Cancer | 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. | Adverse events were assessed in the Safety Analysis Set. | Posted | Count of Participants | Participants | From the date of signing the informed consent form up to 40 (+7) days after last dose, up to approximately 18 months |
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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.
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DS-8201a Cohort A | Participants in Cohort A were HER2-positive (IHC 3+ or IHC 2+/ISH +) who received DS-8201a once every 3 weeks. | 36 | 53 | 20 | 53 | 53 | 53 |
| EG001 | DS-8201a Cohort B | Participants in Cohort B were HER2 IHC 2+/ISH - who received DS-8201a once every 3 weeks. | 10 | 15 | 6 | 15 | 15 | 15 |
| EG002 | DS-8201a Cohort C | Participants in Cohort C were HER2/IHC 1+ who received DS-8201a once every 3 weeks. | 12 | 18 | 9 | 18 | 18 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Infected fistula | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Meningism | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gastrointestinal ulcer | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Gastrointestinal stoma complication | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Intestinal prolapse | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Blood magnesium decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal sepsis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Fluid retention | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Flushing | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Jaundice | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Proctalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Retinal vein occlusion | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Vasogenic cerebral oedema | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Contact for Clinical Trial Information | Daiichi Sanyko, Inc. | 908-992-6400 | CTRinfo@dsi.com |
| Sep 21, 2021 |
| Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000614160 | trastuzumab deruxtecan |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Japan |
|
| Italy |
|
| Spain |
|
| United Kingdom |
|
| Title | Measurements |
|---|---|
|
| Confirmed SD |
|
| Confirmed PD |
|
| Confirmed Non-evaluable |
|
| Unconfirmed CR |
|
| Unconfirmed PR |
|
| Unconfirmed SD |
|
| Unconfirmed PD |
|
| Unconfirmed Non-evaluable |
|
|
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Participants in Cohort C were HER2/IHC 1+ who received DS-8201a once every 3 weeks. |
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Participants in Cohort C were HER2/IHC 1+ who received DS-8201a once every 3 weeks. |
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| DS-8201a Cohort C |
Participants in Cohort C were HER2/IHC 1+ who received DS-8201a once every 3 weeks. |
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