A Dose-escalation Study in Subjects With Advanced Malignancies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01072266|
Recruitment Status : Completed
First Posted : February 22, 2010
Last Update Posted : November 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor Advanced Cancer Metastatic Cancer||Drug: INCB028060||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||January 2013|
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.
- 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. ]
- 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. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01072266
|United States, Maryland|
|Baltimore, Maryland, United States|
|United States, Tennessee|
|Nashville, Tennessee, United States|
|Study Director:||Lance Leopold||Incyte Corporation|