NCT01985555

Phase I Study of the Volitinib (HMPL-504) in Patients With Advanced Solid Tumors

A Phase I, Open-label, Multicenter Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of Volitinib in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Hutchison Medipharma Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of single and multiple doses of volitinib administered to patients with locally advanced or metastatic solid tumors and determine MTD (Maximum Tolerated Dose) or RPTD(recommended Phase 2 dose).

Detailed description

The primary endpoint is evaluation of safety and tolerability during all the study of therapy following the initiation of multiple dosing of HMPL-504. The safety and tolerability variables to be evaluated in this study are adverse events, physical examinations, vital signs (specifically including blood pressure), clinical laboratory evaluations including serum chemistry, hematology (Maximum Tolerated Dose), and urinalysis (with detailed sediment analysis, proteinuria, and 24-hour urine for collection for protein), and electrocardiograms (ECGs) in triplicate, Incidence and nature of DLTs (Dose-Limiting Toxicity), to determine the MTD (Maximum Tolerated Dose).

Conditions

• Tumors

Interventions

Type	Name	Description
DRUG	Volitinib(HMPL-504)	Volitinib(HMPL-504) is a tablet in the form of 25 mg ,100mg and 200 mg,oral,once daily or 2 times a day.

Timeline

• Start date: 2013-05-01
• Primary completion: 2019-04-01
• Completion: 2019-04-01
• First posted: 2013-11-15
• Last updated: 2019-07-15

Locations

1 site across 1 country: China