The top finishers for each of the age divisions below receive a personalized engraved finisher medal. Age group medals will be mailed to the winners following the official verification of all race results.
Layout table for study information Study Type : Interventional (Clinical Trial) ActualEnrollment : 122 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment Official Title: A Phase 2, Multicenter, Randomized, Study of Trastuzumab Deruxtecan in Participants With HER2-overexpressing Locally Advanced, Unresectable or Metastatic Colorectal Cancer (DESTINY-CRC02) Actual Study Start Date : March 5, 2021 Estimated Primary Completion Date : February 2023 Estimated Study Completion Date : August 2023 Arms and Interventions Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Arm Intervention/treatment Experimental: T-DXd 5.4 mg/kg Q3WParticipants will be randomized to receive intravenous T-DXd administered at a dose of 5.4 mg/kg every 3 weeks (Q3W). Drug: DS-8201a 5.4 mg/kg Q3WDS-8201a for injection will be administered intravenously (IV) at a dose of 5.4 mg/kg every 3 weeks (Q3W)Other Name: T-DXd Experimental: T-DXd 6.4 mg/kg Q3WParticipants will be randomized to receive intravenous T-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W). Drug: DS-8201a 6.4 mg/kg Q3WDS-8201a for injection will be administered intravenously (IV) at a dose of 6.4 mg/kg every 3 weeks (Q3W)Other Name: T-DXd Outcome Measures Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Primary Outcome Measures : Change in Confirmed Objective Response Rate by Blinded Independent Central Review Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Human epidermal growth factor receptor 2-overexpressing Metastatic Colorectal Cancer [ Time Frame: The first 80 participants have 12 weeks of follow-up or have discontinued the treatment for the Interim Analysis (IA), 6 months after the last participant is registered for the primary analysis ]Confirmed objective response rate (ORR), defined as the proportion of participants with complete response (CR) or partial response (PR), will be 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. Secondary Outcome Measures : Change in Confirmed Objective Response Rate by Investigator Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Human epidermal growth factor receptor 2 (HER2)-overexpressing Metastatic Colorectal Cancer [ Time Frame: The first 80 participants have 12 weeks of follow-up or have discontinued the treatment for the Interim Analysis (IA) and 6 months after the last participant is registered for the primary analysis ]Confirmed objective response rate (ORR), defined as the proportion of participants with complete response (CR) or partial response (PR), will be assessed by the Investigator 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. Change in Duration of Response Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Human epidermal growth factor receptor 2 (HER2)-overexpressing Metastatic Colorectal Cancer [ Time Frame: The first 80 participants have 12 weeks of follow-up or have discontinued the treatment for the Interim Analysis (IA) and 6 months after the last participant is registered for the primary analysis ]Duration of response (DoR) is defined as the time from the initial response (complete response [CR] or partial response [PR]) until documented tumor progression or death from any cause. DoR is only defined for participants who achieved confirmed CR or PR. 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. Change in Disease Control Rate Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Human Epidermal Growth Factor Receptor 2 (HER2) -Overexpressing Metastatic Colorectal Cancer [ Time Frame: The first 80 participants have 12 weeks of follow-up or have discontinued the treatment for the Interim Analysis (IA) (DCR) and 6 months after the last participant is registered for the primary analysis (DCR, CBR) ]Disease control rate (DCR) is the sum of complete response (CR), partial response (PR), and stable disease (SD) rates. CR was defined as 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. DCR based on Investigator assessments Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Change in Clinical Benefit Ratio Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Human Epidermal Growth Factor Receptor 2 (HER2) -Overexpressing Metastatic Colorectal Cancer [ Time Frame: The first 80 participants have 12 weeks of follow-up or have discontinued the treatment for the Interim Analysis (IA) (DCR) and 6 months after the last participant is registered for the primary analysis (DCR, CBR) ]Clinical Benefit Ratio (CBR), defined as the proportion of participants who achieved complete response (CR), partial response (PR), and stable disease (SD) for at least 6 months. CR was defined as 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. CBR based on the blinded independent central review (BICR) and CBR based on Investigator assessments Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Change in Progression Free Survival Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Human epidermal growth factor receptor 2 (HER2)-overexpressing Metastatic Colorectal Cancer [ Time Frame: The first 80 participants have 12 weeks of follow-up or have discontinued the treatment for the Interim Analysis (IA) (PFS) and 6 months after the last participant is registered for the primary analysis (PFS, OS) ]Progression-Free Survival (PFS), defined as the time from date of randomization/registration until first objective radiographic tumor progression or death from any cause, based on the blinded independent central review (BICR) and Investigator assessment according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Change in Overall Survival Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Human epidermal growth factor receptor 2 (HER2)-overexpressing Metastatic Colorectal Cancer [ Time Frame: The first 80 participants have 12 weeks of follow-up or have discontinued the treatment for the Interim Analysis (IA) (PFS) and 6 months after the last participant is registered for the primary analysis (PFS, OS) ]Overall Survival (OS), defined as the time from date of randomization/registration until death from any cause. The Percentage of Participants Reporting Treatment-emergent Adverse Events Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Human epidermal growth factor receptor 2 (HER2)-overexpressing Metastatic Colorectal Cancer [ Time Frame: 12 weeks after the first 80 participants are randomized for Interim Analysis (IA), up to approximately 18 months. ]Treatment-emergent Adverse Events (TEAEs) The Percentage of Participants Reporting Treatment-emergent Adverse Events Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Human epidermal growth factor receptor 2 (HER2)-overexpressing Metastatic Colorectal Cancer [ Time Frame: 6 months after the last participant is registered for the primary analysis, up to approximately 30 months. ]Treatment-emergent Adverse Events (TEAEs) 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) [ Time Frame: 6 months after the last participant is registered or later ]The EORTC QLQ-C30 consists of 30 questions assessing global health-related quality of life, five aspects of subject functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), and six single-items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures range in score from 0 to 100. Higher scores for functioning scales and global health status indicate a better level of functioning while higher scores on the symptom and single-item scales indicate a higher level of symptoms. 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) [ Time Frame: 6 months after the last participant is registered or later ]The EORTC QLQ-CR29 consists of functional scales (Body Image, Future projections, Weight, Sexual interest) and symptom scales (urinary frequency, blood and mucus in stool, stool frequency, urinary incontinence, dysuria, abdominal pain, buttock pain, bloating, dry mouth, hair loss, taste, flatulence, fecal incontinence, sore skin, embarrassment, impotence, dyspareunia). All scales and single-item measurements range from 0 to 100. A higher score on a functional scale indicates better functioning. A higher score for a symptom scale/item indicates higher symptomatology and problem level. 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) [ Time Frame: 6 months after the last participant is registered or later ]The EQ-5D questionnaire is made up for two components; health state description and evaluation. The EQ-5D-5L is the health state description for measuring health status. The descriptive system comprises the 5 dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participants self-rate each dimension on a 5-point, categorical scale: no problems, slight problems, moderate problems, severe problems, and extreme problems. Patient-Reported Outcomes (PROs) in Patient's Global Impression of Treatment Tolerability (PGI-TT) [ Time Frame: 6 months after the last participant is registered or later ]The PGI-TT item is included to assess how a patient perceives the overall tolerability of the study treatment over the past 7 days. This is a single-item questionnaire, and patients will rate the bother associated with any treatment-related symptoms using response options on a 5-point scale ranging from 1 (Not at all) to 5 (Very much); 1-Not at all, 2-A little bit, 3-Somewhat, 4-Quite a bit, 5-Very much. Higher scores indicate a worse outcome. Patient-Reported Outcomes (PROs) in Patient Global Impression of Symptom Severity (PGIS) [ Time Frame: 6 months after the last participant is registered or later ]The PGIS item is included to assess how a patient perceives the overall severity of cancer symptoms over the past 7 days. This is a single-item questionnaire, and patients will choose the response that best describes the severity of their overall cancer symptoms with options on a 6-point scale ranging from 1 (No symptoms) to 6 (Very Severe); 1-No Symptoms, 2-Very Mild, 3-Mild, 4-Moderate, 5-Severe, 6-Very Severe. Higher scores indicate a worse outcome. Patient-Reported Outcomes (PROs) in Patient Global Impression of Change (PGIC) Scores [ Time Frame: 6 months after the last participant is registered or later ]The PGIC item is included to assess how a patient perceives their overall change in health status since the start of study treatment. This is a single-item questionnaire, and patients will choose from response options on a 7-point scale ranging from 1 (Much Better) to 7 (Much worse); 1- Much Better, 2-Moderately Better, 3-A Little Better, 4-About the Same, 5-A Little Worse, 6-Moderately Worse, 7-Much Worse. Higher scores indicate a worse outcome. Inpatient Healthcare Resource Utilization [ Time Frame: 6 months after the last participant is registered or later ]Healthcare resource use will be captured/collected, including inpatient admissions, intensive care unit admissions, and length of stay in hospital. Serum Concentration of Trastuzumab Deruxtecan (T-DXd) [ Time Frame: 6 months after the last participant is registered or later ] Serum Concentration of Total Anti-Human Epidermal Growth Factor Receptor 2 (HER2) Antibody [ Time Frame: 6 months after the last participant is registered or later ] Serum Concentration of Active Metabolite MAAA-1181a [ Time Frame: 6 months after the last participant is registered or later ] Percentage of Participants Positive for Treatment-emergent Anti-drug Antibodies (ADAs) and Neutralizing antibodies (NAb) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) [ Time Frame: 6 months after the last participant is registered or later ] Eligibility CriteriaGo to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Layout table for eligibility information Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria KEY Inclusion Criteria:
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