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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04744831
Registration number
NCT04744831
Ethics application status
Date submitted
19/01/2021
Date registered
9/02/2021
Date last updated
13/03/2024
Titles & IDs
Public title
Trastuzumab Deruxtecan in Participants With HER2-overexpressing Advanced or Metastatic Colorectal Cancer
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Scientific title
A Phase 2, Multicenter, Randomized, Study of Trastuzumab Deruxtecan in Participants With HER2-overexpressing Locally Advanced, Unresectable or Metastatic Colorectal Cancer (DESTINY-CRC02)
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Secondary ID [1]
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2020-004782-39
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Secondary ID [2]
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DS8201-A-U207
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Universal Trial Number (UTN)
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Trial acronym
DESTINY-CRC02
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Colorectal Cancer
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Condition category
Condition code
Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - DS-8201a 5.4 mg/kg Q3W
Treatment: Drugs - DS-8201a 6.4 mg/kg Q3W
Experimental: T-DXd 5.4 mg/kg Q3W - Participants will be randomized to receive intravenous T-DXd administered at a dose of 5.4 mg/kg every 3 weeks (Q3W).
Experimental: T-DXd 6.4 mg/kg Q3W - Participants will be randomized to receive intravenous T-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W).
Treatment: Drugs: DS-8201a 5.4 mg/kg Q3W
DS-8201a for injection will be administered intravenously (IV) at a dose of 5.4 mg/kg every 3 weeks (Q3W)
Treatment: Drugs: DS-8201a 6.4 mg/kg Q3W
DS-8201a for injection will be administered intravenously (IV) at a dose of 6.4 mg/kg every 3 weeks (Q3W)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Objective Response Rate (ORR) Based on Blinded Independent Central Review Following IV Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2-overexpressing Metastatic Colorectal Cancer
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Assessment method [1]
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Confirmed objective response rate (ORR), defined as the number (percentage) of participants with complete response (CR) or partial response (PR), were assessed by blinded independent central review (BICR) based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as the disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
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Timepoint [1]
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6 months post-dose administration to data cut off, up to 20 months
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Secondary outcome [1]
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Confirmed Objective Response Rate by Investigator Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Overexpressing Metastatic Colorectal Cancer
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Assessment method [1]
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Timepoint [1]
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6 months post-dose administration to data cut off, up to 40 months
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Secondary outcome [2]
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Duration of Response Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Overexpressing Metastatic Colorectal Cancer
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Assessment method [2]
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Timepoint [2]
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6 months post-dose administration to data cut off, up to 40 months
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Secondary outcome [3]
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Disease Control Rate Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2) -Overexpressing Metastatic Colorectal Cancer
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Assessment method [3]
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Timepoint [3]
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6 months post-dose administration to data cut off, up to 40 months
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Secondary outcome [4]
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Clinical Benefit Rate Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2) -Overexpressing Metastatic Colorectal Cancer
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Assessment method [4]
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Timepoint [4]
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6 months post-dose administration to data cut off, up to 40 months
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Secondary outcome [5]
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Progression Free Survival Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Overexpressing Metastatic Colorectal Cancer
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Assessment method [5]
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Timepoint [5]
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6 months post-dose administration to data cut off, up to 40 months
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Secondary outcome [6]
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Overall Survival Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Overexpressing Metastatic Colorectal Cancer
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Assessment method [6]
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Timepoint [6]
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6 months post-dose administration to data cut off, up to 40 months
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Secondary outcome [7]
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Percentage of Participants Reporting Treatment-emergent Adverse Events Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Overexpressing Metastatic Colorectal Cancer
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Assessment method [7]
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Timepoint [7]
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Baseline up to 40 months
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Secondary outcome [8]
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Change From Baseline in Patient-Reported Outcomes (PROs) in European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30)
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Assessment method [8]
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Timepoint [8]
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Baseline up to 40 months
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Secondary outcome [9]
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Change From Baseline in Patient-Reported Outcomes (PROs) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Colorectal Cancer 29 (QLQ-CR29)
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Assessment method [9]
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Timepoint [9]
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Baseline up to 40 months
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Secondary outcome [10]
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Patient-Reported Outcomes (PROs) in the EuroQol Questionnaire (EQ) of 5 Dimensions (5D) on a Standardized 5- Level (5L) Descriptive Health Status Scale (EQ-5D-5L)
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Assessment method [10]
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Timepoint [10]
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Baseline up to 40 months
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Secondary outcome [11]
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Patient-Reported Outcomes (PROs) in Patient's Global Impression of Treatment Tolerability (PGI-TT)
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Assessment method [11]
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Timepoint [11]
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Baseline up to 40 months
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Secondary outcome [12]
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Patient-Reported Outcomes (PROs) in Patient Global Impression of Symptom Severity (PGIS)
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Assessment method [12]
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Timepoint [12]
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Baseline up to 40 months
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Secondary outcome [13]
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Patient-Reported Outcomes (PROs) in Patient Global Impression of Change (PGIC) Scores
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Assessment method [13]
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Timepoint [13]
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Baseline up to 40 months
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Secondary outcome [14]
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Inpatient Healthcare Resource Utilization
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Assessment method [14]
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Timepoint [14]
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Baseline up to 40 months
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Secondary outcome [15]
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Serum Concentration of T-DXd
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Assessment method [15]
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Timepoint [15]
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Baseline up to 40 months
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Secondary outcome [16]
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Serum Concentration of Total Anti-Human Epidermal Growth Factor Receptor 2 (HER2) Antibody
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Assessment method [16]
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Timepoint [16]
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Baseline up to 40 months
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Secondary outcome [17]
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Serum Concentration of Active Metabolite MAAA-1181a
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Assessment method [17]
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Timepoint [17]
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Baseline up to 40 months
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Secondary outcome [18]
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Percentage of Participants Positive for Treatment-emergent Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) in Participants Who Were Administered T-DXd
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Assessment method [18]
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Timepoint [18]
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Baseline up to 40 months
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Eligibility
Key inclusion criteria
KEY
Participants must meet all of the following criteria to be eligible for
randomization/registration into the study:
1. Adults aged =20 years in Japan, Taiwan, and Korea, or those aged =18 years in other
countries, at the time the Informed Consent Forms (ICFs) are signed.
2. Pathologically-documented, unresectable, recurrent, or metastatic colorectal
adenocarcinoma. Participants must have v-raf murine sarcoma viral oncogene homologue
B1 (BRAF) wild-type cancer and rat sarcoma viral oncogenes homologue (RAS) status
identified in primary or metastatic site.
3. The following therapies should be included in prior lines of therapy:
1. Fluoropyrimidine, oxaliplatin, and irinotecan, unless contraindicated
2. Anti-epidermal growth factor receptor (EGFR) treatment, if RAS wild-type and if
clinically indicated
3. Anti-vascular endothelial growth factor (VEGF) treatment, if clinically indicated
4. Anti-programmed death ligand 1 (PD-(L)-1) therapy, if the tumor is microsatellite
instability (MSI)-high/deficient mismatch repair (dMMR), or tumor mutational
burden (TMB)-high, if clinically indicated
4. Confirmed human epidermal growth factor 2 (HER2)-overexpressing status assessed by
central laboratory and defined as immunohistochemistry (IHC) 3+ or IHC 2+/ in situ
hybridization (ISH) +.
5. Presence of at least one measurable lesion assessed by the Investigator per Response
Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
7. Has left ventricular ejection fraction (LVEF) =50% within 28 days before
randomization/registration.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Participants who meet any of the following criteria will be disqualified from entering the
study:
1. Medical history of myocardial infarction (MI) within 6 months before
randomization/registration, symptomatic congestive heart failure (CHF) (New York Heart
Association Class II to IV). Participants with troponin levels above the upper limit
of normal (ULN) at Screening (as defined by the manufacturer), and without any
MI-related symptoms, should have a cardiologic consultation before
randomization/registration to rule out MI.
2. Has a corrected QT interval corrected with Fridericia's formula (QTcF) prolongation to
>470 msec (female participants) or >450 msec (male participants) based on the average
of the Screening triplicate 12-lead electrocardiograms (ECGs).
3. Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that
required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis
cannot be ruled out by imaging at Screening.
4. Lung-specific intercurrent clinically significant illnesses including, but not limited
to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the
randomization/registration, severe asthma, severe chronic obstructive pulmonary
disease [COPD], restrictive lung disease, pleural effusion, etc.).
5. Any autoimmune, connective tissue, or inflammatory disorders (eg, rheumatoid
arthritis, Sjögren syndrome, sarcoidosis, etc.) where there is documented, or a
suspicion of, pulmonary involvement at the time of Screening.
6. Prior pneumonectomy.
7. Has spinal cord compression or clinically active central nervous system metastases,
defined as untreated and symptomatic, or requiring therapy with corticosteroids or
anticonvulsants to control associated symptoms. Participants with clinically inactive
brain metastases may be included in the study. Participants with treated brain
metastases that are no longer symptomatic and who require no treatment with
corticosteroids or anticonvulsants may be included in the study if they have recovered
from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed
between the end of whole-brain radiotherapy and randomization/registration.
8. Participants with leptomeningeal carcinomatosis.
9. Has known human immunodeficiency virus (HIV) infection.
10. Active hepatitis B and/or hepatitis C infection, such as those with serologic evidence
of viral infection within 28 days before study randomization/registration.
Participants with past or resolved hepatitis B virus (HBV) infection are eligible if
hepatitis B surface antigen (HBsAg) negative (-) and antibody to hepatitis B core
antigen (anti-HBc) positive (+).
Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase
chain reaction is negative for HCV ribonucleic acid (RNA).
11. Previous treatment with a DXd-containing antibody-drug conjugate (ADC).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/03/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
122
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Flinders Medical Centre (FMC) - Bedford Park
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Recruitment hospital [2]
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Blacktown Hospital - Blacktown
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Recruitment hospital [3]
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Royal Brisbane & Women's Hospital - Brisbane
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Recruitment hospital [4]
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Monash Medical Centre - Clayton
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Recruitment hospital [5]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment postcode(s) [1]
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- Bedford Park
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Recruitment postcode(s) [2]
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- Blacktown
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Recruitment postcode(s) [3]
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- Brisbane
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Recruitment postcode(s) [4]
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- Clayton
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Recruitment postcode(s) [5]
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- Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Kentucky
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Country [2]
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United States of America
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State/province [2]
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North Carolina
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United States of America
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State/province [3]
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Tennessee
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Country [4]
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United States of America
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State/province [4]
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Texas
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Country [5]
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Belgium
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State/province [5]
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Bruxelles
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Country [6]
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Belgium
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State/province [6]
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Edegem
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Country [7]
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Belgium
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State/province [7]
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Gent
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Country [8]
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France
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State/province [8]
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Lyon Cedex 03
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Country [9]
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France
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State/province [9]
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MONTPELLIER Cedex 5
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Country [10]
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France
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State/province [10]
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Nantes
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Country [11]
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France
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State/province [11]
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Paris
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Country [12]
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France
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State/province [12]
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Toulouse
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Country [13]
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Italy
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State/province [13]
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Milano
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Country [14]
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Italy
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State/province [14]
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Padova
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Country [15]
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Italy
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State/province [15]
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Vicenza
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Country [16]
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Japan
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State/province [16]
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Aichi
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Country [17]
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Japan
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State/province [17]
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Chiba
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Country [18]
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Japan
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State/province [18]
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Ehime
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Country [19]
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Japan
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State/province [19]
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Fukuoka
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Country [20]
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Japan
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State/province [20]
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Hokkaido
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Country [21]
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Japan
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State/province [21]
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Kanagawa
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Country [22]
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Japan
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State/province [22]
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Osaka
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Country [23]
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Japan
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State/province [23]
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Tokyo
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Country [24]
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Korea, Republic of
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State/province [24]
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Goyang-si
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Country [25]
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Korea, Republic of
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State/province [25]
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Gyeonggi-do
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Country [26]
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Korea, Republic of
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State/province [26]
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Seoul
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Country [27]
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Spain
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State/province [27]
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Barcelona
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Spain
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State/province [28]
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Madrid
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Country [29]
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Spain
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State/province [29]
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Pamplona
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Country [30]
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Taiwan
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State/province [30]
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Taichung
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Country [31]
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Taiwan
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State/province [31]
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Tainan
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Country [32]
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Taiwan
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State/province [32]
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Taipei
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Country [33]
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Taiwan
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State/province [33]
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Taoyuan
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Country [34]
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United Kingdom
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State/province [34]
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Daiichi Sankyo
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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AstraZeneca
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will evaluate the efficacy, safety, and pharmacokinetics of Trastuzumab deruxtecan
(T-DXd) in participants with human epidermal growth factor 2 (HER2)-overexpressing locally
advanced, unresectable, or metastatic colorectal cancer (mCRC).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04744831
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Global Clinical Leader
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Address
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Daiichi Sankyo
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04744831
Download to PDF