A phase II study of eribulin monotherapy for advanced extramammary Paget's disease

JRCT ID: jRCT2011220022

Registered date:28/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: extramammary Paget's disease
• Date of first enrollment: 17/05/2023
• Target sample size: 18
• Study type: Interventional
• Intervention(s): A cycle will last 21 days. Eribulin will be administered intravenously once daily at a dose of 1.4 mg/m2(body surface area) over a period of 2 to 5 minutes on Day 1 (D1) and Day 8 (D8).

Outcome(s)

• Primary Outcome: Overall Response Rate(RECIST1.1) (based on central imaging assessment)

Secondary Outcome

Efficacy endpoints
(1)Overall response rate(investigator-assessed)
(2)Disease control rate (based on central imaging assessment)
(3)Overall survival
(4)Progression-free survival (based on central imaging assessment)
(5)Duration of response(based on central imaging assessment)
(6)Time to response (based on central imaging assessment)
(7)Best overall response (based on central imaging assessment)
(8)Maximum tumor change

Safety endpoint Adverse events per Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
(1)Number and percentage of subjects with adverse events that occurred after administration of the study drug
(2)Number and percentage of subjects with Grade 3 or higher adverse events
(3)Number and percentage of subjects with serious adverse events
(4)Number and percentage of subjects who discontinued the study drug due to adverse events
(5)Number and percentage of subjects for whom the administration of the study drug was postponed due to adverse events
(6)Number and percentage of subjects whose adverse events led to dose reduction of the study drug

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1)Pathologically proven (by histology or cytology) EMPD,surgically incurable
(2)At least 20 years of age at time of informed consent
(3)Can provide written informed consent voluntarily
(4)Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
(5)At least 1 measurable lesion per RECIST (Version 1.1)
(6)Results of most recent laboratory tests performed within 14 days before enrollment (can be on the same day of the week as the enrollment day within 2 weeks before enrollment) meet the following criteria:
a) Neutrophil count >= 1500/mm3L
b) Platelet count >= 100,000/mm3L
c) Hemoglobin level >= 10 g/dL
d) Serum creatinine <= 3.0 x upper limit of normal (ULN)
e) Total bilirubin or direct bilirubin <= 1.5 x ULN
f) AST andALT <= 3.0 x ULN

Exclude criteria

(1)History of hypersensitivity to any ingredient of the study drug
(2)Judged to be at high medical risk due to poorly controlledserious comorbidity, non-malignant systemic disease, or poorly controlled active infection. This could include, but is not limited to, the following examples:
-Peripheral neuropathy
-Interstitial pneumonia
-Psychiatric disorder that impedes patient's ability to sign the Informed Consent Form
(3)Received anticancer drug within 4 weeks before starting study treatment
(4)Received radiotherapy within 4 weeks before starting study treatment
(5)Received a blood transfusion (platelets or red blood cells) within 4 weeks before starting study treatment
(6)Received a live viral or bacterial vaccine within 4 weeks before starting study treatment
(7)Received study drug(including Unapproved or off-labeled drug) within 4 weeks before starting study treatment
(8)Patients with multiple cancers(Patients with completely resected basal cell carcinoma, stage I spinous cell carcinoma, intraepithelial carcinoma, intramucosal carcinoma or superficial bladder cancer, or other cancer that has not recurred for at least 2 years may be enrolled.)
(9)Patients with central nervous system metastases
(10)Known human immunodeficiency virus (HIV) infection
(11)Hepatitis B virus surface antigen (HBsAg) positive, or individuals with known or suspected active hepatitis C virus (HCV) infection. Note: Patients who have tested positive for hepatitis B core antibody (HBcAb) or hepatitis B surface antibody (HBsAb) are eligible for enrollment, but their HBV nucleic acid test (HBV-DNA quantification) results must be below the limit of detection. Patients who are positive for hepatitis C virus antibody (HCVAb) must have HCV nucleic acid test (HCV-RNA quantification) results below the limit of detection.
(12)Pregnant, possibly pregnant, or does not consent to use contraception for the 3-month period frominformed consent to the end of the study treatment
(13)Participating or planning to participate in another clinical trialor interventional study
(14)Deemed bytheinvestigator to be unsuitable to participate in the study for any other reason

Related Information

• Primary Sponsor: Yanagi Teruki
• Secondary Sponsor: Maeda Takuya
• Source(s) of Monetary Support: Hokkaido University Hospital