NCT01195311

A Dose-escalation Study in Subjects With Advanced Malignancies

A Phase I, Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of INCB024360 in Patients With Advanced Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (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 INCB024360 (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. For subject safety, the first subject in each cohort will be administered drug for one week before the next two subjects in the cohort can begin drug administration. Doses will be escalated unless a dose-limiting toxicity (DLT) is observed in one of three subjects. An expanded cohort of up to 15 patients may be recruited to further explore safety at the 'maximum tolerated dose' or at a lower, pharmacologically active, dose.

Conditions

• Solid Tumors and Hematologic Malignancy

Interventions

Type	Name	Description
DRUG	INCB024360	INCB024360: 25 mg and 100 mg tablets Doses will be escalated in accordance with the dosing schedule.

Timeline

• Start date: 2010-07-01
• Primary completion: 2013-05-01
• Completion: 2013-07-01
• First posted: 2010-09-06
• Last updated: 2018-01-17

Locations

2 sites across 1 country: United States