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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027887
Receipt No. 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 2019/08/01

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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
Email 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
Email triumph_core@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

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
Email 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
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 No longer recruiting
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
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 23 Day
Last modified on
2019 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031949

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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