NCT04013217

Evaluate Eribulin ORA in Subjects With Solid Tumors

A Phase I Study With Expansion Cohorts to Assess the Safety, Tolerability, and Activity of Eribulin ORA in Subjects With Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Health Hope Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a nonrandomized, open-label, dosed escalation, safety activity, and PK study to determine the MTD and optimal dosing regimen of Eribulin ORA.

Detailed description

This is a multicenter, open-label safety, tolerability, pharmacokinetic, and activity study. Eligible subjects will be adults with advanced solid tumors. Groups of 3 to 6 subjects will receive a single dose of Eribulin ORA on Day 1 and Day 8 of a 21 day cycle and will be followed for toxicity. If non linearity in PK is observed, additional subjects will be added with study drug administered on Day 1 and 8 once every three weeks cycle. Subjects who tolerate the study drug and have stable disease or better response will be eligible to receive ongoing treatment.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Eribulin ORA	Oral eribulin mesylate will be supplied as an aqueous solution and HM30181A-UK

Timeline

• Start date: 2019-07-29
• Primary completion: 2022-03-02
• Completion: 2022-03-02
• First posted: 2019-07-09
• Last updated: 2025-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study