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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000031221 |
Receipt No. | R000035488 |
Scientific Title | A multicenter phase II study of eribulin monotherapy in patients with BRAF V600E mutant metastatic colorectal cancer |
Date of disclosure of the study information | 2018/03/26 |
Last modified on | 2020/08/17 |
Basic information | ||
Public title | A multicenter phase II study of eribulin monotherapy in patients with BRAF V600E mutant metastatic colorectal cancer
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Acronym | BRAVERY study | |
Scientific Title | A multicenter phase II study of eribulin monotherapy in patients with BRAF V600E mutant metastatic colorectal cancer
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Scientific Title:Acronym | BRAVERY study | |
Region |
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Condition | |||
Condition | colorectal cancer
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Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | YES |
Objectives | |
Narrative objectives1 | To evaluate the clinical efficacy and safety of eribulin monotherapy in patients with BRAF V600E mutant metastatic colorectal cancer |
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 Disease control rate;DC Overall survival;OS Incidences of adverse events |
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 |
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Interventions/Control_1 | Eribulin is administered intravenously at a dose of 1.4mg/m^2/day on Days 1 and 8, repeated every 21 days. | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1.Written informed consent
2.Age of 20 years or older 3.Confirmed diagnosis of metastatic colorectal cancer (mCRC) by tissue diagnosis 4.Refractory or tolerate to at least one regimen (including irinotecan or oxaliplatin) containing fluoropyrimidine for mCRC 5.BRAF V600E mutant CRC 6.Measurable lesions according to RECIST version 1.1 7.Being able to provide FFPE colorectal cancer tissue 8.PS:0-1 9.Life expectancy of 3 months or longer 10.Adequate organ function 11.Women of childbearing potential who are negative in a urine pregnancy test and agree to take appropriate precautions to avoid pregnancy from screening through 90 days after the final administration of eribulin |
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Key exclusion criteria | 1.History of treatment with eribulin
2.Symptomatic brain metastases or meningeal dissemination 3.Leptomeningeal disease 4.Medical history of clinically significant cardiac diseases 5.History of other malignant tumors within 3 years before the start of study treatment. 6.Previous treatment with any of the following: a.Last dose of cytotoxic agents or regorafenib within 14 days b.Last dose of cetuximab, panitumumab, bevacizumab, aflibercept, or ramucirumab within 3 weeks c.Last dose of biologic therapy (except cetuximab, panitumumab, bevacizumab, aflibercept, or ramucirumab), immunotherapy, non-marketed investigational anticancer treatments within 4 weeks d.Prior radiotherapy to 30% of bone marrow e.Major surgery within 2 weeks 7.Known HIV infection 8.Positive HBs antigen 9.Diagnosed as liver cirrhosis 10.Female patients who are breastfeeding 11.Other medically important abnormalities |
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Target sample size | 42 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | National Cancer Center Hospital East | ||||||
Division name | Department of GI Oncology | ||||||
Zip code | 277-8577 | ||||||
Address | 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan | ||||||
TEL | 04-7133-1111 | ||||||
BRAVERY_core@east.ncc.go.jp |
Public contact | |||||||
Name of contact person |
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Organization | Aichi Cancer Center Hospital | ||||||
Division name | Department of Clinical Oncology | ||||||
Zip code | 4648681 | ||||||
Address | 1-1 Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan | ||||||
TEL | 052-764-6111 | ||||||
Homepage URL | |||||||
BRAVERY_core@east.ncc.go.jp |
Sponsor | |
Institute | National Cancer Center Hospital |
Institute | |
Department |
Funding Source | |
Organization | Japan Agency for Medical Research and Development |
Organization | |
Division | |
Category of Funding Organization | Government offices of other countries |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) | Project of Translational and Clinical Research Core Centers |
IRB Contact (For public release) | |
Organization | National Cancer Center Hospital Institutional Review Board |
Address | Tsukiji 5-1-1, Chuo-ku, Tokyo, 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 | 愛知県がんセンター(愛知県)、国立がん研究センター東病院(千葉県)、九州がんセンター(福岡県)、四国がんセンター(愛媛県)、北海道大学病院(北海道)、聖マリアンナ医科大学病院(神奈川県)、がん研究会有明病院(東京都)、大阪大学医学部附属病院(大阪府) |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 | No longer recruiting | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035488 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |