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A Phase I study of patients with advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer

Basic Information

Recruitment status	completed
Health condition(s) or Problem(s) studied	Patients with epithelial ovarian, primary peritoneal, or fallopian tube cancer
Date of first enrollment	01/04/2016
Target sample size	30
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : ET-743, PLD INN of investigational material : Trabectedin, Doxorubicin Therapeutic category code : 42- Antineoplastic agents Dosage and Administration for Investigational material : On Day 1, PLD 30 mg/m2 solution reconstituted in accordance with the latest package insert of PLD Injection will be administered by drip infusion over 90 minutes. After the end of PLD infusion, ET-743 diluted in at least 500 mL of normal saline, will be administered via a central venous line over 3 hours. The starting dose of ET-743 will be 0.9 mg/m2. Then, the patient will be followed up for 20 days until Day 21. control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -

Outcome(s)

Primary Outcome	safety dose-limiting toxicity CTCAE Ver. 4.03
Secondary Outcome	efficacy safety Safety, Efficacy CTCAE Ver. 4.03, RECIST Ver. 1.1

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Female
Include criteria	- Patients who provided written informed consent to participate as subjects of this study - Patients who have histologically or cytologically proven epithelial ovarian, primary peritoneal, or fallopian tube cancer - Other
Exclude criteria	- Patients with severe diseases or medical conditions - Other