NIPH Clinical Trials Search

Phase II trial of eribulin in patients with recurrent glioblastoma (ENIGMA)

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	Glioblastoma
Date of first enrollment	2018/01/10
Target sample size	38
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	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.

Outcome(s)

Primary Outcome	One-year survival rate
Secondary Outcome	Overall survival (OS), Progression-free survival (PFS), Response rate, QOL, safety

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	75years-old
Gender	Male and Female
Include criteria
Exclude 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.