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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031857
Receipt No. R000036377
Scientific Title A multi-center proof-of-concept phase2 study of encorafenib + binimetinib + cetuximab in patients with BRAF non-V600E mutated metastatic colorectal cancer
Date of disclosure of the study information 2018/04/01
Last modified on 2018/10/05

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Basic information
Public title A multi-center proof-of-concept phase2 study of encorafenib + binimetinib + cetuximab in patients with BRAF non-V600E mutated metastatic colorectal cancer
Acronym BIG BANG Study
Scientific Title A multi-center proof-of-concept phase2 study of encorafenib + binimetinib + cetuximab in patients with BRAF non-V600E mutated metastatic colorectal cancer
Scientific Title:Acronym BIG BANG Study
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the clinical efficacy, safety, and proof-of-concept (POC) of combination therapy consisting of BRAF inhibitor (encorafenib), MEK inhibitor (binimetinib), and an anti-epidermal growth factor receptor (EGFR) antibody (cetuximab) in patients with BRAF non-V600E mutated metastatic CRC.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Confirmed objective response rate by investigators' assessment
Key secondary outcomes

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 of encorafenib + binimetinib+ cetuximab
One cycle is 28 days.
Binimetinib: 45 mg, twice daily, oral
Encorafenib: 300 mg, once daily, oral
Cetuximab: 400 mg/m2 for initial dose, 250 mg/m2 for subsequent doses, weekly, intravenous infusion
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 all of the inclusion criteria A and B, and do not fall under the any of exclusion criteria will be enrolled as patients for study treatment.
At least 8 patients with lesions eligible for biopsy should be enrolled in the primary analysis parts; biopsy of lesions of which measurement in accordance with the RECIST version 1.1 is performed is accepted.


Inclusion criteria A
1.Age of 20 years or older on the day of signing informed consent
2.Confirmed diagnosis of advanced (unresectable) or metastatic colorectal cancer (mCRC) by tissue diagnosis
3.Patients who did not respond to or tolerate at least one chemotherapy regimen (including irinotecan or oxaliplatin) containing fluoropyrimidine drugs in the treatment of metastatic CRC, and are thus eligible for second or later line treatment
4.RAS wild-type and BRAF non-V600E mutated CRC. The diagnosis should be based on the results of associated genetic tests, and the record should be available
5.Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1

Inclusion criteria B:
1.Measurable lesions in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
2.Patients with the adequate organ functions
3.Adequate cardiac function characterized by the following at screening
1)Left ventricular ejection fraction (LVEF) over 50% as determined by a MUGA scan or ECHO;
2)Mean triplicate QT interval corrected for heart rate using Fridericia's formula (QTcF) value less than 480 msec
4.Women of childbearing potential who are negative in a urine pregnancy test
5.Female patients and male patients must agree to take appropriate precautions to avoid pregnancy from the day of signing informed consent through 90 days after the final administration of investigational drugs.
Key exclusion criteria 1.History of treatment with epidermal growth factor receptor (EGFR) inhibitors including anti-EGFR antibody drugs
2.History of treatment with BRAF inhibitors or MEK inhibitors
3.History of treatment with regorafenib
4.Symptomatic brain metastases or meningeal dissemination
5.Leptomeningeal disease
6.Medical history, current condition, or risk of retinal vein occlusion
7.Inadequately controlled diabetes requiring insulin therapy
8.Acute or chronic pancreatitis
9.Medical history of clinically significant cardiac diseases
10.Gastrointestinal function or gastrointestinal diseases that significantly interfere with absorption, distribution, metabolism, and excretion of the study drugs
11.No history of other malignant tumors within 3 years before the start of study treatment. In cases of lesions corresponding to carcinoma in situ and intramucosal carcinoma judged to be cured by local therapy, non-metastatic prostate cancer not requiring systemic therapy, and other solid cancers that do not require therapy or are not estimated to be adversely affected by the study treatment, patients will not be excluded from the study when the coordinating committee concludes after consultation that there is no effect on the patient's prognosis.
12.Medical history of thromboembolism within 6 months
13.Concurrent neuromuscular disorder that is associated with the potential of elevated CK
14.Previous treatment with any of the following,
a.cyclical chemotherapy within a period of 14 days
b.bevacizumab, aflibercept, or ramucirumab within 3 weeks
c.biologic therapy (except bevacizumab, aflibercept, or ramucirumab), immunotherapy, marketed small molecular compounds, or non marketed investigational anticancer treatments within 4 weeks, or within a period 5fold the halflife (whichever is shorter)
d.prior radiotherapy to 30% of bone marrow
Target sample size 36

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideaki Bando
Organization National Cancer Center Hospital East
Division name Department of Gastrointestinal Oncology
Zip code
Address 6-5-1,Kashiwanoha,Kashiwa,Chiba,277-8577,Japan
TEL 04-7133-1111
Email BIGBANG_core@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Kotani
Organization National Cancer Center Hospital East
Division name Department of Gastrointestinal Oncology
Zip code
Address 6-5-1,Kashiwanoha,Kashiwa,Chiba,277-8577,Japan
TEL 04-7133-1111
Homepage URL
Email BIGBANG_core@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital Eas
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

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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中央病院 (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)

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 01 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 Enrolling by invitation
Date of protocol fixation
2018 Year 02 Month 22 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 23 Day
Last modified on
2018 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036377

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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