Spots Global Cancer Trial Database for A Dose-escalation Study in Subjects With Advanced Malignancies

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Trial Identification

Brief Title: A Dose-escalation Study in Subjects With Advanced Malignancies

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 ID: NCT01195311

Conditions

Solid Tumors and Hematologic Malignancy

Interventions

INCB024360

Study Description

Brief 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.

Detailed Description: