A Dose-escalation Study in Subjects With Advanced Malignancies

Completed · Phase 1

Conditions studied: Solid Tumors and Hematologic Malignancy

In brief

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.

Key facts

Study ID

NCT01195311

Run by

Incyte Corporation

People needed

52

Starts

2010-07-01

Expected to finish

2013-07-01

Last updated by the study team

2018-01-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with neoplastic disease refractory to currently available therapies or for which no effective treatment is available
• Subjects with life expectancy of 12 weeks or longer.
• Subjects with Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.

You may not qualify if…

• Subjects who received any anti-cancer medications in the 21 days prior to receiving their first dose of study medication or 6 weeks for mitomycin-C or nitrosoureas.
• Subjects with history of brain metastases or spinal cord compression.
• Subjects who have undergone a bone marrow or solid organ transplant.
• Subjects who have had major surgery within 4 weeks prior to study entry or had minor surgical procedure within 7 days prior to initiating treatment.
• Subjects with a history of any gastrointestinal condition
• Is receiving any compound that is known to be a potent inducer or inhibitor of CYP3A4
• Subjects with an active autoimmune process or is receiving therapy for an autoimmune disease
• Subjects treated with a serotonin reuptake inhibitor within 3 weeks prior to study entry

Where it is running

• Study site — Chicago, Illinois, United States
• Study site — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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