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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016115
Receipt No. R000018716
Scientific Title Phase II trial of regorafenib in patients with imatinib resistrant gastrointestinal stromal tumor
Date of disclosure of the study information 2015/01/13
Last modified on 2019/01/07

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Basic information
Public title Phase II trial of regorafenib in patients with imatinib resistrant gastrointestinal stromal tumor
Acronym RESET for GIST
Scientific Title Phase II trial of regorafenib in patients with imatinib resistrant gastrointestinal stromal tumor
Scientific Title:Acronym RESET for GIST
Region
Japan

Condition
Condition Gastrointestinal stromal tumor
(GIST)
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy and safety of regorafenib in patients with imatinib resistant GIST
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Progression free survival rate at 24weeks.
Key secondary outcomes Progression free survival:PFS
Objective response rate:RR
Disease control rate:DCR
Clinical effective rate(Objective response or SD persists more than 22weeks.)
Adverse event:AE

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 Regorafenib(160mg)is administered orally once daily
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 1) Patients who have been fully informed about the study and have given written consent themselves
2) Patients aged 20 years or older at the time of consent
3) Patients with histologically confirmed metastatic and/or unresectable GIST.
4) Imatinib was discontinued due to disease progression or an adverse event.
5) No prior treatment with Regorafenib or Sunitinib.
6) ECOG Performance Status 0-1
7) Patients able to take oral medications.
8) With measurable lesion according to RECIST ver.1.1..
9) Adequate organ function
a. Hemoglobin >=8.0 g/dL
b. Absolute neutrophil count >=1,000 /mm3
c. Platelet count >=100,000 /mm3
d. Total bilirubin <=1.8 mg/dL
e. AST and ALT <=100 IU/L
f. Serum creatinine <=1.5mg/dL
10) Women of childbearing potential must have a negative pregnancy test within 7days prior to enrollment.Patients who do have intention that uses effective contraception method until 6 months after administering investigational drug.
11) Patient is willing or able to comply with the protocol.
Key exclusion criteria 1) Serious coexisting illness as follows.
a. Active double cancer(s)
b. CNS metastasis
c. Uncontrollable infectious disease
d. Uncontrollable pleural effusion, ascites, or cardiac effusion within 2weeks prior to enrollment
e. Ileus, renal failure, hepatic failure or cerebrovascular disorder within 6months prior to enrollment
f. Interstitial pneumonia or pulmonary fibrosis apparent on CT
g. Uncontrolled diabetes mellitus
h. Uncontrolled hypertension
i.Cardiac infarction, serious or unstable angina or New York Heart Association Class III or IV within 12 months prior to enrollment
j Needs antiarrhythmic treatment
k. Gastrointestinal bleeding within 4 weeks.
l. Positive HBs antigen or HIV antibody
m. Need immunosuppressive therapy
n. Uncontrolled mental disease or the psychotic manifestation
o. Pheochromocytoma
2) Receive the treatment as follows.
a.Major surgery therapy within 4 weeks prior to enrollment.
b.Chemotherapy (except Imatinib) within 3 weeks prior to enrollment.
c. Imatinib within 1 week prior to enrollment.
d.Wide field radiotherapy 4 weeks prior to enrollment
e.Other investigational drugs within 4 weeks prior to enrollment.
3) Unrecovered AEs related to prior treatment are Grade >= 2 according to CTCAE.
4) Blood transfusion or G-CSF within 14 days prior to enrollment.
5) Gastrointestinal malabsorption
6) Serious renal failure or proteinuria >= 2+ within 7days prior to enrollment
7) Thromboembolic event within 6 months prior to enrollment
8) Untrecovered wound or traumatic fracture
9) Need anticoaglation
10) Women during pregnancy or lactation ,
11) Known hypersensitivity to Regorafinib or Regorafinib's excipient
12) Tendency to hemorrhages or Grade >= 3 bleeding within 4 weeks.
13) Patient is judged by the investigator to be inappropriate for study participation for any reason.
Target sample size 38

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshihiko Doi
Organization National Cancer Center East Hospital

Division name Experimental Therapeutics
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL 04-7133-1111
Email tdoi@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoichi Naito
Organization National Cancer Center East Hospital
Division name Experimental Therapeutics
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL 04-7133-1111
Homepage URL
Email ynaito@east.ncc.go.jp

Sponsor
Institute National Cancer Center East Hospital
Institute
Department

Funding Source
Organization Bayer Yakuhin Ltd
Organization
Division
Category of Funding Organization Profit organization
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 国立がん研究センター中央病院(東京都)
国立がん研究センター東病院(千葉県)
北海道大学病院(北海道)
大阪大学医学部附属病院(大阪府)
兵庫県立がんセンター(兵庫県)
九州大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2015 Year 01 Month 13 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 Completed
Date of protocol fixation
2014 Year 11 Month 04 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 30 Day
Last follow-up date
2018 Year 12 Month 05 Day
Date of closure to data entry
2019 Year 02 Month 28 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 01 Month 05 Day
Last modified on
2019 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018716

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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