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History of Changes for Study: NCT04744831
Trastuzumab Deruxtecan in Participants With HER2-overexpressing Advanced or Metastatic Colorectal Cancer (DESTINY-CRC02)
Latest version (submitted June 10, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 4, 2021 None (earliest Version on record)
2 March 15, 2021 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 May 11, 2021 Contacts/Locations and Study Status
4 June 7, 2021 Contacts/Locations and Study Status
5 June 15, 2021 Contacts/Locations and Study Status
6 July 7, 2021 Study Status and Contacts/Locations
7 August 4, 2021 Study Status and Contacts/Locations
8 September 1, 2021 Contacts/Locations and Study Status
9 October 12, 2021 Contacts/Locations and Study Status
10 November 30, 2021 Contacts/Locations and Study Status
11 December 21, 2021 Study Status and Contacts/Locations
12 February 16, 2022 Contacts/Locations and Study Status
13 March 25, 2022 Contacts/Locations and Study Status
14 April 12, 2022 Recruitment Status, Contacts/Locations, Study Status and Study Design
15 June 10, 2022 Study Status
Comparison Format:

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Study NCT04744831
Submitted Date:  February 4, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: DS8201-A-U207
Brief Title: Trastuzumab Deruxtecan in Participants With HER2-overexpressing Advanced or Metastatic Colorectal Cancer (DESTINY-CRC02)
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)
Secondary IDs: 2020-004782-39 [EudraCT Number]
Open or close this module Study Status
Record Verification: February 2021
Overall Status: Not yet recruiting
Study Start: February 2021
Primary Completion: February 2023 [Anticipated]
Study Completion: August 2023 [Anticipated]
First Submitted: January 19, 2021
First Submitted that
Met QC Criteria:
February 4, 2021
First Posted: February 9, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
February 4, 2021
Last Update Posted: February 9, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Daiichi Sankyo, Inc.
Responsible Party: Sponsor
Collaborators: AstraZeneca
Syneos Health
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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).
Detailed Description: This 2-stage study will evaluate participants with locally advanced, unresectable, or metastatic HER2-overexpressing colorectal cancer (CRC) (immunohistochemistry [IHC] 3+ or IHC 2+/ in situ hybridization [ISH]+) of v-raf murine sarcoma viral oncogene homologue B1 (BRAF) wild-type and either rat sarcoma viral oncogenes homologue (RAS) wild-type or mutant tumor type, previously treated with standard therapy. In the first stage, participants will be randomized 1:1 with 2 doses of T-DXd. After Stage 1 enrollment is complete, all further eligible participants will be registered to T-DXd administered IV in Stage 2. Participants will receive the assigned dose of T-DXd until progression of disease or the participant meets one of the discontinuation criteria.
Open or close this module Conditions
Conditions: Advanced Colorectal Cancer
Keywords: Metastatic Colorectal Cancer
HER2 Overexpressing Colorectal Cancer
BRAF Wild-Type Status
DS-8201a
Trastuzumab deruxtecan
Advanced Colorectal Cancer
T-DXd
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 120 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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).
Drug: 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)
Other Names:
  • T-DXd
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).
Drug: 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)
Other Names:
  • T-DXd
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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:
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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)
8. 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)
9. 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.
10. 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.
11. 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.
12. 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.
13. 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.
14. 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.
15. 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.
16. Serum Concentration of Trastuzumab Deruxtecan (T-DXd)
[ Time Frame: 6 months after the last participant is registered or later ]

17. 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 ]

18. Serum Concentration of Active Metabolite MAAA-1181a
[ Time Frame: 6 months after the last participant is registered or later ]

19. 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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

KEY Inclusion Criteria:

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.

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).
Open or close this module Contacts/Locations
Central Contact Person: Daiichi Sankyo Contact for Clinical Trial Information
Telephone: 908-992-6400
Email: CTRinfo@dsi.com
Central Contact Backup: (Asia sites) Daiichi Sankyo Contact for Clinical Trial Information
Telephone: +81-3-6225-1111(M-F 9-5 JST)
Email: dsclinicaltrial@daiichisankyo.co.jp
Study Officials: Global Clinical Leader
Study Director
Daiichi Sankyo, Inc.
Locations: United States, Arizona
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Contact:Contact: Tomislav Dragovich tomislav.dragovich@bannerhealth.com
United States, Kentucky
Norton Cancer Institute
Louisville, Kentucky, United States, 40217
Contact:Contact: Michael Driscoll kylee.fleig@nortonhealthcare.org
United States, Tennessee
Sarah Cannon (Tennessee Oncology - Nashville)
Nashville, Tennessee, United States, 37203
Contact:Contact: Johanna Bendell jbendell@tnonc.com
United States, Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Contact:Contact: Kanwal Raghav kpraghav@mdanderson.org
United States, Wisconsin
Medical College of Wisconsin/ Froedtert Hospital
Wauwatosa, Wisconsin, United States, 53226
Contact:Contact: Ben George bgeorge@mcw.edu
Australia
Flinders Medical Centre (FMC)
Bedford Park, Australia
Contact:Contact: Christos Karapetis chris.karapetis@sa.gov.au
Blacktown Hospital
Blacktown, Australia
Contact:Contact: Adnan Nagrial Adnan.Nagrial@health.nsw.gov.au
Royal Brisbane & Women's Hospital
Brisbane, Australia
Contact:Contact: Matthew Burge matthew.burge@health.qld.gov.au
Monash Medical Centre
Clayton, Australia
Contact:Contact: Sophia Frentzas Sophia.Frentzas@monashhealth.org
Peter MacCallum Cancer Centre
Melbourne, Australia
Contact:Contact: Jeanne Tie Jeanne.Tie@petermac.org
Belgium
UCL St-Luc
Bruxelles, Belgium
Contact:Contact: Marc Van Den Eynde marc.vandeneynde@uclouvain.be
UZ Antwerpen
Edegem, Belgium
Contact:Contact: Marc Peeters marc.peeters@uza.be
UZ GENT
Gent, Belgium
Contact:Contact: Karen Geboes karen.geboes@uzgent.be
France
Hopital Jean Minjoz
Besançon, France
Contact:Contact: Cristophe Borg xtoph.borg@gmail.com
ICM-Val d'Aurelle
MONTPELLIER Cedex 5, France
Contact:Contact: Thibault Mazard thibault.mazard@icm.unicancer.fr
University Hospital of nantes
Nantes, France
Contact:Contact: Jaafar Bennouna jaafar.bennouna@chu-nantes.fr
Centre Antoine Lacassagne
Nice, France
Contact:Contact: Eric Francois eric.francois@nice.unicancer.fr
Hopital St Antoine
Paris, France
Contact:Contact: Thierry André thierry.andre@aphp.fr
Centre de Lutte Contre le Cancer CLCC - Institut Curie
Saint-Cloud, France
Contact:Contact: Cindy Neuzillet cindy.neuzillet@curie.fr
Chu Toulouse
Toulouse, France
Contact:Contact: Rosine Guimbaud guimbaud.r@chu-toulouse.fr
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano, Italy
Contact:Contact: Maria Di Bartolomeo maria.dibartolomeo@istitutotumori.mi.it
Grande Ospedale Metropolitano Niguarda
Milano, Italy
Contact:Contact: Siena Salvatore salvatore.siena@unimi.it
Istituto Oncologico Veneto Irccs
Padova, Italy
Contact:Contact: Sara Lonardi sara.lonardi@iov.veneto.it
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Contact:Contact: Chiara Cremolini chiaracremolini@gmail.com
Aienda Ospedaliera San Camillo Forlanini
Rome, Italy
Contact:Contact: Carlo Garufi cgarufi@scamilloforlanini.rm.it
Azienda ULSS 8 Berica
Vicenza, Italy
Contact:Contact: Giuseppe Aprile giuseppe.aprile@aulss8.veneto.it
Japan
National Cancer Center Hospital East
Chiba, Japan
Contact:Contact: Takayuki Yoshino tyoshino@east.ncc.go.jp
Kyusyu Cancer Center Hospital
Fukuoka, Japan
Contact:Contact: Taito Esaki esaki.taito.fz@mail.hosp.go.jp
Kanagawa Cancer Center Hospital
Kanagawa, Japan
Contact:Contact: Manabu Shiozawa shiozawam@kcch.jp
National Hospital Organization Shikoku Cancer Center
Matsuyama, Japan
Contact:Contact: Tomohiro Nishina t-nishina@shikoku-cc.go.jp
Aichi Cancer Center Hospital
Nagoya, Japan
Contact:Contact: Toshiki Masuishi tmasuishi@aichi-cc.jp
National Hospital Organization Osaka National Hospital
Osaka, Japan
Contact:Contact: Takeshi Kato ken-kato@momo.so-net.ne.jp
Hokkaido University Hospital
Sapporo, Japan
Contact:Contact: Yoshito Komatsu ykomatsu@ac.cyberhome.ne.jp
National Cancer Center Hospital
Tokyo, Japan
Contact:Contact: Atsuo Takashima atakashi@ncc.go.jp
The Cancer Institute Hospital of JFCR
Tokyo, Japan
Contact:Contact: Kensei Yamaguchi kensei.yamaguchi@jfcr.or.jp
Kindai University Hospital
Ōsaka-sayama, Japan
Contact:Contact: Hisato Kawakami kawakami_h@med.kindai.ac.jp
Korea, Republic of
Seoul National University Bundang Hospital
Gyeonggi-do, Korea, Republic of
Contact:Contact: Keun-Wook Lee hmodoctor@snubh.org
Asan Medical Center
Seoul, Korea, Republic of
Contact:Contact: Tae Won Kim twkimmd@amc.seoul.kr
Samsung Medical Center
Seoul, Korea, Republic of
Contact:Contact: Young Suk Park pys27hmo@skku.edu
Seoul National University Hospital
Seoul, Korea, Republic of
Contact:Contact: Tae-You Kim kimty@snu.ac.kr
Severance Hospital Yonsei University Health System
Seoul, Korea, Republic of
Contact:Contact: Seung Hoon Beom beomsh@yuhs.ac
Spain
Hospital Universitari Vall dHebron
Barcelona, Spain
Contact:Contact: Elena Elez meelez@vhio.net
Hospital Universitario 12 de Octubre
Madrid, Spain
Contact:Contact: Cristina Gravalos cristina.gravalos@salud.madrid.org
Clinica Universitaria de Navarra
Pamplona, Spain
Contact:Contact: Javier Rodriguez jrodriguez@unav.es
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital KMUH
Kaohsiung, Taiwan
Contact:Contact: Jaw-Yuan Wang jayuwa@kmu.edu.tw
Chang Gung Memorial Hospital-LinKou
Niaosong, Taiwan
Contact:Contact: Tsai Sheng Yang a481124@cgmh.org.tw
China Medical University Hospital
Taichung, Taiwan
Contact:Contact: Li-Yuan Bai lybai6@gmail.com
Chang Gung Memorial Hospital CGMH - Kaohsiung Branch
Tainan, Taiwan
Contact:Contact: Hong Hwa Chen Hong-Hwa Chen
National Cheng Kung University Hospital
Tainan, Taiwan
Contact:Contact: Yu-Min Yeh i5485111@gmail.com
National Taiwan University Hospital
Taipei, Taiwan
Contact:Contact: Kun-Huei Yeh khyeh@ntu.edu.tw
United Kingdom
Beatson Glasgow
Glasgow, United Kingdom
Contact:Contact: Janet Graham janet.graham@ggc.scot.nhs.uk
The Royal Marsden Hospital
London, United Kingdom
Contact:Contact: Ian Chau ian.chau@rmh.nhs.uk
UCLH Trust
London, United Kingdom
Contact:Contact: Daniel Hochhauser d.hochhauser@ucl.ac.uk
The Christie
Manchester, United Kingdom
Contact:Contact: Mark Saunders mark.saunders8@nhs.net
Open or close this module IPDSharing
Plan to Share IPD: Yes
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/
Supporting Information:
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame:
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.
Access Criteria:
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.
URL: http://vivli.org/ourmember/daiichi-sankyo/
Open or close this module References
Citations:
Links:
Available IPD/Information:

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