NIPH Clinical Trials Search

Study of E7389 Liposomal Formulation in Subjects With Solid Tumor

Basic Information

Recruitment status	completed
Health condition(s) or Problem(s) studied	Solid Tumor
Date of first enrollment	18/08/2017
Target sample size	149
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : E7389-LF INN of investigational material : Eribulin mesylate Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : E7389-LF: Injection control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -

Outcome(s)

Primary Outcome	efficacy Maximum tolerated dose (MTD) of E7389 liposomal formulation (E7389-LF) [ Time Frame: Cycle 1 (21 days): Schedule 1; Cycle 1 (28 days): Schedule 2 ]
Secondary Outcome	other -

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	1.Participants with advanced, nonresectable, or recurrent solid tumor for which no alternative standard therapy or no effective therapy exists 2.Ex-part only: BC-1: BC-1 with confirmed diagnosis, HER2 negative, prior chemotherapy of anthracycline and taxane (unless contraindicated), and up to 3 prior chemotherapy regimens to advanced or metastatic disease ACC: nonresectable ACC with confirmed diagnosis and one or more prior chemotherapy regimens (unless contraindicated) GC, EGC and SCLC: nonresectable GC, EGC and SCLC with confirmed diagnosis and 2 or more prior chemotherapy regimens (unless contraindicated) (1 or more prior chemotherapy regimens for EGC participant who received combination therapy of platinum and taxane). BC-2:BC with confirmed diagnosis, HER2 negative, no prior chemotherapy regimens to advanced or metastatic disease (as for triple-negative BC, the subjects diagnosed as PD-L1 negative or subjects clinically judged as not eligible for immuno-checkpoint inhibitor-containing regimen are eligible) 3.Life expectancy of >=12 weeks 4.ECOG-PS of 0 to 1 5.Japanese participants aged >=20 years at the time of informed consent 6.All adverse events (AEs) due to previous anti-cancer therapy have either returned to Grade 0 or 1 except for alopecia 7.Adequate renal function 8.Adequate bone marrow function 9.Adequate liver function 10.Ex-part only: At least one measurable lesion based on RECIST 1.1 11.Willing and able to give informed consent and comply with all aspects of the protocol
Exclude criteria	1.Have clinically, significant cardiovascular disease 2.History of hypersensitivity reaction by liposomal formulation agent 3.Major surgery within 21 days prior to starting study drug 4.Known intolerance to the study drug or any of the excipients 5.Known to be human immunodeficiency virus (HIV) positive 6.Known to be Hepatitis B, or Hepatitis C positive 7.Evidence of clinically significant disease/status (e.g. cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments 8.Females who are breastfeeding or pregnant at Screening or Baseline 9.Ex-part/BC-2 only: Patients who had been confirmed radiological disease progression within 12 months after completion of taxane as neo- and/or adjuvant therapy