Status:
COMPLETED
A Dose-escalation Study in Subjects With Advanced Malignancies
Lead Sponsor:
Incyte Corporation
Conditions:
Solid Tumors and Hematologic Malignancy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01195311
Start Date
July 1 2010
End Date
July 1 2013
Last Update
January 17 2018
Active Locations (2)
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1
Chicago, Illinois, United States
2
Philadelphia, Pennsylvania, United States