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 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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1, Open-label, Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of INCB028060 in Subjects With Advanced Malignancies|
- Safety and tolerability will be the primary endpoint and will be assessed by monitoring the frequency, duration, and severity of AEs [ Time Frame: Baseline and every 1-2 weeks based on protocol visit schedule until the end of study or early termination visit. ] [ Designated as safety issue: Yes ]
- c-MET inhibitory activity determined by the relationship between blood levels of INCB028060 and the percent inhibition of c-MET phosphorylation [ Time Frame: Predose, specific hours post-dose on day and Day 15 of Cycle 1. ] [ Designated as safety issue: No ]Samples will be collected at 0 (predose) and 2, 4, and 6 hours after dosing on Day 1 and Day 15 of Cycle 1 for subjects undergoing full PK analysis.
|Study Start Date:||January 2010|
|Study Completion Date:||January 2013|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Subjects will be enrolled and treated in cohorts of three and each observed a minimum of 28 days before the next group of patients may be enrolled and receive study drug. The initial cohort will be treated with 10 mg QD. The second cohort will be treated with 20 mg QD. The third cohort will be treated with 50 mg QD. Subsequent cohorts will be treated with two times the dose of the prior cohort to a limited toxicity level.
10 mg and 50 mg capsules will be provided and dosed per the dosing schedule.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01072266
|United States, Maryland|
|Baltimore, Maryland, United States|
|United States, Michigan|
|Detroit, Michigan, United States|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States|
|United States, Tennessee|
|Nashville, Tennessee, United States|
|Study Director:||Lance Leopold||Incyte Corporation|