DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing Colorectal Cancer (DESTINY-CRC01)
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| ClinicalTrials.gov Identifier: NCT03384940 |
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Recruitment Status :
Completed
First Posted : December 28, 2017
Last Update Posted : January 20, 2021
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Sponsor:
Daiichi Sankyo Co., Ltd.
Collaborators:
Daiichi Sankyo, Inc.
AstraZeneca
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )
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Brief Summary:
The main objective of this study is to test the safety and effectiveness of DS-8201a for participants with HER2-expressing advanced colorectal cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Colorectal Neoplasm | Drug: DS-8201a | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 90 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2, Multicenter, Open-label Study of DS-8201a in Subjects With HER2-expressing Advanced Colorectal Cancer |
| Actual Study Start Date : | February 23, 2018 |
| Actual Primary Completion Date : | August 9, 2019 |
| Actual Study Completion Date : | November 12, 2020 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Trastuzumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: DS-8201a Cohort A
Cohort A is comprised of participants with HER2-positive (IHC 3+ or IHC 2+/ISH +) who will receive DS-8201a once every 3 weeks Enrollment to this cohort was closed and this cohort is active until study completion. |
Drug: DS-8201a
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
Other Name: Trastuzumab deruxtecan |
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Experimental: DS-8201a Cohort B
Cohort B is comprised of participants with HER2 IHC 2+/ISH - who will receive DS-8201a once every 3 weeks This cohort is active. |
Drug: DS-8201a
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
Other Name: Trastuzumab deruxtecan |
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Experimental: DS-8201a Cohort C
Cohort C is comprised of participants with HER2 IHC 1+ who will receive DS-8201a once every 3 weeks Enrollment to this cohort was closed and this cohort is active until study completion. |
Drug: DS-8201a
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
Other Name: Trastuzumab deruxtecan |
Primary Outcome Measures :
- Objective response rate (ORR) per imaging assessment [ Time Frame: from Cycle 1 Day 1 through disease progression (within 18 months) ]Percentage of participants with objective response per independent central imaging facility review based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 in Cohort A
Secondary Outcome Measures :
- Progression-free survival [ Time Frame: within 18 months ]Percentage of participants still alive without the disease getting worse
- Overall survival (OS) [ Time Frame: at 18 months ]Percentage of participants still alive
- Duration of response [ Time Frame: within 18 months ]Length of time response continued
- Disease control rate (DCR) [ Time Frame: within 18 months ]Percentage of participants with controlled disease
- ORR assessed by the investigator based on RECIST version 1.1 [ Time Frame: within 18 months ]Percentage of participants with objective response as assessed by the investigator, based on RECIST version 1.1
- Maximum serum/plasma concentration (Cmax) [ Time Frame: within 21 days ]Categories: DS-8201a, total anti-HER2 antibody, and MAAA-1181a
- Time to Cmax (Tmax) [ Time Frame: within 21 days ]Categories: DS-8201a, total anti-HER2 antibody, and MAAA-1181a
- Area under the concentration-time curve (AUC) from dosing until the last quantifiable concentration (AUClast) [ Time Frame: within 21 days ]Categories: DS-8201a, total anti-HER2 antibody, and MAAA-1181a
- AUC from the time of dosing until day 21 (AUC0-21d) [ Time Frame: at Day 21 ]Categories: DS-8201a, total anti-HER2 antibody, and MAAA-1181a
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Has pathologically documented unresectable, recurrent, or metastatic colorectal adenocarcinoma (until sponsor's notification to the study sites, subject must be a RAS/BRAF wild-type cancer)
- Has received at least 2 prior regimens of standard treatment
- Has measurable disease assessed by the investigator based on RECIST version 1.1.
- Has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1
Exclusion Criteria:
- Has a medical history of myocardial infarction within 6 months, symptomatic congestive heart failure
- Has a medical history of clinically significant lung disease
- Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03384940
Locations
Show 25 study locations
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Daiichi Sankyo, Inc.
AstraZeneca
Investigators
| Study Director: | Global Clinical Leader | Daiichi Sankyo, Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Daiichi Sankyo Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT03384940 |
| Other Study ID Numbers: |
DS8201-A-J203 2017-003466-28 ( EudraCT Number ) 173808 ( Registry Identifier: JAPIC CTI ) DESTINY-C01 ( Other Identifier: Daiichi Sankyo and AstraZeneca ) |
| First Posted: | December 28, 2017 Key Record Dates |
| Last Update Posted: | January 20, 2021 |
| Last Verified: | January 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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 Materials: |
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: | https://vivli.org/ourmember/daiichi-sankyo/ |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):
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Oncology HER2 Colorectal cancer Antibody drug conjugate ADC |
Additional relevant MeSH terms:
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Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Trastuzumab Antineoplastic Agents, Immunological Antineoplastic Agents |