A Dose-escalation Study in Subjects With Advanced Malignancies
Completed · Phase 1
Conditions studied: Solid Tumor, Advanced Cancer, Metastatic Cancer
In brief
This is an open label, dose escalation study using a 3 + 3 design to determine if INCB028060 (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. Doses will be escalated unless a dose-limiting toxicity (DLT) is observed in one of three subjects.
Key facts
- Study ID
- NCT01072266
- Run by
- Incyte Corporation
- People needed
- 45
- Starts
- 2010-01-01
- Expected to finish
- 2013-01-01
- Last updated by the study team
- 2017-11-22
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 clinically significant non-healing or healing wounds or subjects with lung tumor lesions with increased likelihood of bleeding
- Subjects with a history of any gastrointestinal condition
Where it is running
- Study site — Baltimore, Maryland, United States
- Study site — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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