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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030359
Receipt No. R000034631
Scientific Title Phase II trial of eribulin in patients with recurrent glioblastoma (ENIGMA)
Date of disclosure of the study information 2017/12/19
Last modified on 2019/06/14

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Basic information
Public title Phase II trial of eribulin in patients with recurrent glioblastoma (ENIGMA)
Acronym Phase II trial of eribulin in patients with recurrent glioblastoma
Scientific Title Phase II trial of eribulin in patients with recurrent glioblastoma (ENIGMA)
Scientific Title:Acronym Phase II trial of eribulin in patients with recurrent glioblastoma
Region
Japan

Condition
Condition Glioblastoma
Classification by specialty
Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this multicenter open-label single-arm phase II study is to evaluate the safety and efficacy of eribulin mesylate in patients with recurrent glioblastoma previously treated with temozolomide, radiation therapy and bevacizumab.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes One-year survival rate
Key secondary outcomes Overall survival (OS), Progression-free survival (PFS), Response rate, QOL, safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients receive eribulin mesylate (1.4 mg/m2) intravenously once a week (q1w) on day 1 and day 8, and do not receive the drug on day 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically proven diagnosis of glioblastoma (including giant cell glioblastoma and gliosarcoma).
2) Evidence of progression or recurrence of glioblastoma confirmed on contrast-enhanced MRI within 14 days prior to enrollment. CT with or without contrast enhancement and MRI without contrast enhancement are not allowed. Presence of a measurable lesion is not required.
3) Corticosteroid dose must be stable or decreasing for at least 7 days prior to the contrast-enhanced MRI described in 2).
4) No episode of intracranial (including intratumoral) hemorrhage for 28 days prior to enrollment.
5) No evidence of tumors in the cerebellum, brain stem, pituitary gland, optic nerve and olfactory nerve, and no evidence of meningeal dissemination.
6) Prior treatment with postoperative temozolomide concomitantly with radiotherapy and at least for two cycles (5/28d) as an adjuvant treatment at newly-diagnosed setting.
7) History of bevacizumab treatment.
8) No history of eribulin treatment.
9) More than 180 days after initiation of temozolomide concomitant with radiation therapy have past at enrollment.
10) More than 90 days after completion of radiotherapy have past at enrollment. For patients who underwent reoperation, more than 14 days have past postoperatively at enrollment.
11) More than 28 days after completion of any other chemotherapeutic treatment including bevacizumab have past at enrollment.
12) Age between 20 and 75 years at enrollment.
13) KPS >= 70 within 14 days prior to enrolment.
14) Adequate organ and bone marrow function as defined below. All screening labs should be performed within 14 days prior to enrollment and G-CSF administration is not allowed in this period:
i) absolute neutrophil count >= 1,500/mm3
ii) platelets >= 100,000/mcL
iii) hemoglobin >= 9.0 g/dL
iv) AST <= 100 U/L
v) ALT <= 100 U/L
vi) creatinine <= 1.5mg/dL
15) Written informed consent.
Key exclusion criteria 1) History of malignancy except for malignant glioma for at least 2 years prior to enrollment (those who had adequately treated carcinoma in situ, intramucosal carcinoma or equivalent malignancy can be enrolled).
2) Active infection requiring systemic therapy.
3) Body temperature >= 38 degrees Celsius at enrollment.
4) Clinical or radiographic evidence of interstitial pneumonia or pulmonary fibrosis at enrollment.
5) Positive HIV antibody, HBs antigen or HCV antibody (however, those who are positive for HCV antibody but negative for HCV-RNA detection can be enrolled).
6) Negative HBs antigen but positive HBs or HBc antibody, and positive HBV-DNA detection (those who are negative for HBV-DNA detection can be enrolled). HBV-DNA test is not necessary for those who are positive for HBs antibody only (including medical workers).
7) Women during pregnancy, possible pregnancy or breastfeeding
8) Uncontrolled diabetes mellitus.
9) Clinically significant heart dysfunction, or history of heart dysfunction.
10) Psychosis or with psychotic symptoms that disturb regular daily life and prevent trial participation.
11) Allergy or any reason to prohibit the use of contrast enhancement agent for MRI.
Target sample size 38

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitaka Narita
Organization National Cancer Center Hospital
Division name Department of Neurosurgery and Neuro-Oncology
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL 03-3542-2511
Email yonarita@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masamichi Takahashi
Organization National Cancer Center Hospital
Division name Department of Neurosurgery and Neuro-Oncology
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL 03-3542-2511
Homepage URL
Email ncch1507_enigma_office@ml.res.ncc.go.jp

Sponsor
Institute National Cancer Center
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) Eisai Co., Ltd.

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 埼玉医科大学国際医療センター(埼玉県)、国立がん研究センター中央病院(東京都)、杏林大学医学部付属病院(東京都)、東京女子医科大学病院(東京都)、東京大学医学部附属病院(東京都)、京都大学医学部附属病院(京都府)、熊本大学医学部附属病院(熊本県)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 19 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 Open public recruiting
Date of protocol fixation
2017 Year 09 Month 29 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 10 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
2017 Year 12 Month 12 Day
Last modified on
2019 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034631

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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