A Dose-escalation Study in Subjects With Advanced Malignancies
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|ClinicalTrials.gov Identifier: NCT01195311|
Recruitment Status : Completed
First Posted : September 6, 2010
Last Update Posted : January 17, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors and Hematologic Malignancy||Drug: INCB024360||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||July 2013|
INCB024360: 25 mg and 100 mg tablets Doses will be escalated in accordance with the dosing schedule.
- 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) ]
- Tumor assessment as measured by RECIST criteria [ Time Frame: Measured from baseline through treatment cessation. (Measured every other cycle and end of study) ]
- 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 ]
- 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 ]
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): NCT01195311
|United States, Illinois|
|Chicago, Illinois, United States|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States|
|Study Director:||Lance Leopold, MD||Incyte Corporation|