NIPH Clinical Trials Search

study of E7389 liposomal formulation plus Nivolumab in subjects with solid tumor

Basic Information

Recruitment status	completed
Health condition(s) or Problem(s) studied	Solid Tumor (Phase 2 part: GC, EGC, SCLC)
Date of first enrollment	05/09/2019
Target sample size	116
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : INN of investigational material : Eribulin mesylate Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Generic name etc : INN of investigational material : Nivolumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : -

Outcome(s)

Primary Outcome	safety efficacy To evaluate safety and tolerability and to determine recommended Phase 2 dose (RP2D) in Phase 1b part. To evaluate objective response rate (ORR) of E7389-LF and nivolumab using RP2D in Phase 2 part in each tumor type.
Secondary Outcome	safety efficacy pharmacokinetics progression free survival(Phase2)

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	1. Phase 1b part only: subjects with advanced, nonresectable, or recurrent solid tumor for which no alternative standard therapy or no effective therapy exists (subjects who will be the candidate of treatment by nivolumab monotherapy as standard therapy is acceptable). 2. Phase 2 part only: nonresectable GC, EGC or SCLC subjects with confirmed diagnosis who showed disease progression by investigator's assessment during or after 1st line chemotherapy (2nd line chemotherapy for GC) and did not receive any other systemic chemotherapy to advanced/recurrent disease. 3. Subjects who have accessible tumors for biopsy and agree with tumor biopsy for pre and post treatment of study drug. 4. Life expectancy of >=12 weeks 5. ECOG-PS 0-1 6. Phase 2 part only: At least one measurable lesion based on RECIST 1.1 (Lesions that have had radiotherapy or loco-regional therapies must show evidence of progressive disease to be deemed a measurable lesion).
Exclude criteria	1. Diagnosed with meningeal carcinomatosis. 2. Subjects with brain or subdural metastases or invasion. 3. Subjects with any active, known, or suspected autoimmune disease.