NCT02222363

Study of Safety and Tolerability of VLX600, an Iron Chelator, in Patients With Refractory Advanced Solid Tumors

A Phase I Study of the Safety and Tolerability of VLX600, an Iron Chelator, in Patients With Refractory Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Vivolux AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of the investigational drug VLX600 in patients with refractory advanced solid tumors.

Detailed description

This Phase I, open label dose escalation study of VLX600 in patients with refractory advanced solid tumors will determine the safety profile and maximum tolerated dose (MTD) of VLX600 when administered by intravenous infusion on Days 1, 8, and 15 of each 28-day treatment cycle. Dose escalation will proceed according to the standard "3 + 3" design using doubling doses. The doses are: 10, 20, 40, 80, 160, and 210 mg VLX600.

Conditions

• Refractory Cancer

Interventions

Type	Name	Description
DRUG	VLX600	Patients will receive a dose of VLX600 by 4-hr intravenous infusion using a central venous catheter on Days 1, 8, and 15 of each 28-day treatment cycle. There are the following dose cohorts: 10, 20, 40, 80, 160, and 210 mg VLX600. It is anticipated that patients will receive 6 treatment cycles. In the absence of unacceptable toxicity and disease progression, patients have the option of continuing treatment beyond 6 cycles, if the investigator determines that the patient may benefit further from it.

Timeline

• Start date: 2015-02-18
• Primary completion: 2016-12-28
• Completion: 2016-12-28
• First posted: 2014-08-21
• Last updated: 2018-05-11

Locations

3 sites across 1 country: United States