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 |
Multicenter Phase II study to evaluate efficacy and safety of combination therapy with trastuzumab and pertuzumab in patients with HER2-positive metastatic colorectal cancer
TRIUMPH study
Multicenter Phase II study to evaluate efficacy and safety of combination therapy with trastuzumab and pertuzumab in patients with HER2-positive metastatic colorectal cancer
TRIUMPH study
Japan |
colorectal cancer
Gastroenterology |
Malignancy
YES
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.
Safety,Efficacy
Exploratory
Phase II
Confirmed objective response rate (ORR) by investigators' assessment
- 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)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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.
20 | years-old | <= |
Not applicable |
Male and Female
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
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.
50
1st name | Takayuki |
Middle name | |
Last name | Yoshino |
National Cancer Center Hospital East
Department of Gastrointestinal Oncology
277-8577
6-5-1,Kashiwanoha,Kashiwa,Chiba,Japan
04-7133-1111
triumph_core@east.ncc.go.jp
1st name | Yoshiaki |
Middle name | |
Last name | Nakamura |
National Cancer Center Hospital East
Department of Gastrointestinal Oncology
277-8577
6-5-1,Kashiwanoha,Kashiwa,Chiba, Japan
04-7133-1111
triumph_core@east.ncc.go.jp
National Cancer Center Hospital East
Japan Agency for Medical Research and Development
Non profit foundation
Japan
Institutional review board of national cancer center
6-5-1,Kashiwanoha,Kashiwa,Chiba,Japan
04-7133-1111
irboffice@east.ncc.go.jp
NO
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)
2017 | Year | 07 | Month | 26 | Day |
Unpublished
30
Completed
2017 | Year | 06 | Month | 28 | Day |
2017 | Year | 08 | Month | 09 | Day |
2017 | Year | 12 | Month | 20 | Day |
2022 | Year | 04 | Month | 30 | Day |
2022 | Year | 05 | Month | 30 | Day |
2022 | Year | 07 | Month | 28 | Day |
2023 | Year | 03 | Month | 30 | Day |
2017 | Year | 06 | Month | 23 | Day |
2022 | Year | 12 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031949