A Dose-escalation Study in Subjects With Advanced Malignancies
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I, Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of INCB024360 in Patients With Advanced Malignancies|
- Safety and tolerability as measured by adverse events and dose limiting toxicities [ Time Frame: Measured from baseline through follow-up period (measured during cycle 1 weekly and bi monthly thereafter) ] [ Designated as safety issue: Yes ]
- Tumor assessment as measured by RECIST criteria [ Time Frame: Measured from baseline through treatment cessation. (Measured every other cycle and end of study) ] [ Designated as safety issue: No ]
- Measurement of IDO inhibition in whole blood measured through blood sampling. [ Time Frame: Cycle 1, Day 1 and each 28 day subsequent cycle at Day 1 ] [ Designated as safety issue: No ]
- PK analysis [ Time Frame: Full PK at Days 1, 8 (trough only), 15 at Cycle 1 and trough at each subsequent cycle at Day 1 ] [ Designated as safety issue: No ]
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||May 2013|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
INCB024360: 25 mg and 100 mg tablets Doses will be escalated in accordance with the dosing schedule.
|United States, Illinois|
|Chicago, Illinois, United States|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States|
|Study Director:||Lance Leopold, MD||Incyte Corporation|