UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030359 |
|---|---|
| Receipt number | 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 | 2021/10/13 15:34:13 |
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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 | Yoshitaka |
| Middle name | |
| Last name | Narita |
Organization
National Cancer Center Hospital
Division name
Department of Neurosurgery and Neuro-Oncology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
ncch1507_enigma_office@ml.res.ncc.go.jp
Public contact
Name of contact person
| 1st name | Masamichi |
| Middle name | |
| Last name | Takahashi |
Organization
National Cancer Center Hospital
Division name
Department of Neurosurgery and Neuro-Oncology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
Homepage URL
ncch1507_enigma_office@ml.res.ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
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
National Cancer Center Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
Tel
03-3542-2511
NCC_IRBoffice@ml.res.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
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
38
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
| 2017 | Year | 09 | Month | 29 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
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
| 2021 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034631
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