UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027887 |
|---|---|
| Receipt number | R000031949 |
| Scientific Title | Multicenter Phase II study to evaluate efficacy and safety of combination therapy with trastuzumab and pertuzumab in patients with HER2-positive metastatic colorectal cancer |
| Date of disclosure of the study information | 2017/07/26 |
| Last modified on | 2022/12/26 11:16:51 |
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Basic information
Public title
Multicenter Phase II study to evaluate efficacy and safety of combination therapy with trastuzumab and pertuzumab in patients with HER2-positive metastatic colorectal cancer
Acronym
TRIUMPH study
Scientific Title
Multicenter Phase II study to evaluate efficacy and safety of combination therapy with trastuzumab and pertuzumab in patients with HER2-positive metastatic colorectal cancer
Scientific Title:Acronym
TRIUMPH study
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The objective of this study is to evaluate the efficacy and safety of the combination therapy with trastuzumab and pertuzumab in patients with human epidermal growth factor receptor (HER) 2-positive metastatic colorectal cancer who are refractory or intolerant to standard chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Confirmed objective response rate (ORR) by investigators' assessment
Key secondary outcomes
- Progression-free survival (PFS)
- Duration of response (DoR)
- Time to treatment failure (TTF)
- Disease control rate (DCR)
- Overall survival (OS)
- Confirmed ORR by central assessment
- Incidences of adverse events
- ORR and PFS in the previous regimens containing an anti-EGFR monoclonal antibody (cetuximab or panitumumab)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Combination therapy with trastuzumab and pertuzumab
1) Trastuzumab: 8 mg/kg (first dose), 6 mg/kg (second and subsequent doses), every 3 weeks
2) Pertuzumab: 840 mg (first dose), 420 mg (second and subsequent doses), every 3 weeks
Both drugs will be intravenously administered.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet both the eligibility criteria A and B will be enrolled in the study treatment group. Patients who meet the eligibility criteria A but do not meet the eligibility criteria B will be enrolled in the natural history follow-up group.
Eligibility criteria A:
1)Age 20 years or above
2)Has metastatic colorectal cancer that is histologically diagnosed as adenocarcinoma
3)Has cancer with wild-type KRAS codons 12 and 13 in tumor tissue. If KRAS codons 59, 61, 117, and 146 and NRAS codons 12, 13, 59, 61, 117, and 146 are also analyzed, the statuses for all these RAS codons must be wild type.
4)Meet the following (1) or (2)
(1)Has cancer that meets either of the following based on central assessment with HER2 IHC and HER2 FISH
- IHC3+
- FISH positive (HER2/CEP17 ratio >= 2.0)
(2) Has cancer that is diagnosed with both of the following based on central assessment with liquid biopsy
- HER2 amplified ('++' or '+++' on the qualitative scale) and RAS wild-type
5)Refractory or intolerant to fluoropyrimidine oxaliplatin, irinotecan, cetuximab, or panitumumab
6)Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
7)Has a life expectancy of at least 12 weeks
8)Be able to provide written informed consent
Eligibility criteria B:
1) Has never been treated with HER2-targeted drugs
2) Has a measurable lesion based on the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
3)Is not breast-feeding
4)Is willing to use appropriate contraception
5)Has no history of other malignancies within 3 years before the start of the study treatment
6)Has not undergone another antitumor treatment concurrently
7)Has not undergone major surgery within 4 weeks before the start of study treatment
8)Has serious, clinically significant abnormalities that are acute or chronic
9)Is willing to receive the study treatment
Key exclusion criteria
1)Has a known history of bone marrow transplantation or organ transplantation
2)Has a positive result on the serum pregnancy test
3)Is judged by the investigator to be inappropriate for study participation for any reason.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Yoshino |
Organization
National Cancer Center Hospital East
Division name
Department of Gastrointestinal Oncology
Zip code
277-8577
Address
6-5-1,Kashiwanoha,Kashiwa,Chiba,Japan
TEL
04-7133-1111
triumph_core@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Nakamura |
Organization
National Cancer Center Hospital East
Division name
Department of Gastrointestinal Oncology
Zip code
277-8577
Address
6-5-1,Kashiwanoha,Kashiwa,Chiba, Japan
TEL
04-7133-1111
Homepage URL
triumph_core@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board of national cancer center
Address
6-5-1,Kashiwanoha,Kashiwa,Chiba,Japan
Tel
04-7133-1111
irboffice@east.ncc.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立研究開発法人 国立がん研究センター東病院（千葉県）
国立大学法人 北海道大学病院（北海道）
国立研究開発法人 国立がん研究センター中央病院（東京都）
愛知県がんセンター 中央病院（愛知県）
独立行政法人国立病院機構 四国がんセンター（愛媛県）
独立行政法人国立病院機構 九州がんセンター（福岡県）
独立行政法人国立病院機構 大阪医療センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
30
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 05 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 07 | Month | 28 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 23 | Day |
Last modified on
| 2022 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031949
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