Status:
COMPLETED
Open-Label Study to Assess the Safety/Tolerability in Patients With Solid Tumors
Lead Sponsor:
Incyte Corporation
Conditions:
Solid Tumors and Hematologic Malignancy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To establish the maximum tolerated dose (MTD) of INCB007839 given as multiple doses for 28 days and to determine if a higher MTD can be established when INCB007839 is administered in combination with ...
Eligibility Criteria
Inclusion
- Either non-small cell lung cancer, hormone-refractory prostate cancer, colorectal cancer, breast cancer, or squamous cell cancer of the head and neck that is refractory to standard treatment or for which no effective treatment exists. The patient must have a life expectancy of 12 weeks or longer.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion
- Received any anticancer medications in the 28 days prior to receiving their first dose of study medication
- Evidence of venous thrombosis by flow Doppler examination at Screening
- A history of thrombosis or a coagulation disorder
- Patients with a contraindication to use of low dose warfarin and/or aspirin.
- Any unresolved toxicity greater than grade 2 from previous anticancer therapy, except for stable chronic toxicities not expected to resolve
- Brain metastases or spinal cord compression
- Impaired renal function
- Inadequate bone marrow reserve
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00820560
Start Date
January 1 2005
End Date
January 1 2009
Last Update
January 17 2018
Active Locations (4)
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1
Aurora, Colorado, United States
2
Baltimore, Maryland, United States
3
Philadelphia, Pennsylvania, United States
4
Nashville, Tennessee, United States