NCT02300467

NOV120401 (CKD-516 Tablet) for Advanced Solid Tumors

A Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of NOV120401 (CKD-516 Tablet) in Patients With Advanced Refractory Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: National OncoVenture · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this open-label, dose-escalation phase I trial is to evaluate the safety, tolerability and pharmacokinetic profiles and to assess the efficacy of NOV120401 (CKD-516 Tablet), a novel vascular disrupting agent, in patients with advanced refractory solid tumors.

Detailed description

Vascular disrupting agents are expected to kill cancer cells located in core of tumor tissues by disrupting microvascular structure of tumor. To assess the safety and tolerability of NOV120401 (CKD-516 Tablet), patients with advanced refractory solid tumors will be enrolled in this study. Initial dose of NOV120401 (CKD-516 Tablet) is 5 mg/day, which will be escalated until at least 2 of 6 subjects show dose-limiting toxicities (DLTs). Pharmacokinetic profiles and efficacy by tumor response and vascular disrupting activities will also be assessed.

Conditions

• Advanced Refractory Solid Tumors

Interventions

Type	Name	Description
DRUG	NOV120401	5 to 45 mg/day PO for 5 consecutive days and 2 days off

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2014-11-25
• Last updated: 2015-08-14

Locations

1 site across 1 country: South Korea