NCT01072266

A Dose-escalation Study in Subjects With Advanced Malignancies

A Phase 1, Open-label, Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of INCB028060 in Subjects With Advanced Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, dose escalation study using a 3 + 3 design to determine if INCB028060 (study drug) is safe, well-tolerated and effective in patients with advanced malignancies. Patients will be enrolled and treated in cohorts of three and each observed a minimum of 28 days before the next group is enrolled and may begin to receive study drug. Doses will be escalated unless a dose-limiting toxicity (DLT) is observed in one of three subjects.

Conditions

• Solid Tumor
• Advanced Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	INCB028060	10 mg and 50 mg capsules will be provided and dosed per the dosing schedule.

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-07-01
• Completion: 2013-01-01
• First posted: 2010-02-22
• Last updated: 2017-11-22

Locations

2 sites across 1 country: United States