Solid Tumors and Hematologic Malignancy
Conditions
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 prophylactic anticoagulation and with a 2 and a half day (5 doses) treatment interruption every two weeks.
Interventions
DRUGINCB007839
INCB007839 100 or 200 mg/dose as IR capsules
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identify a maximum tolerable dose as measured through adverse event reporting, ECGs and laboratory assessments | Baseline through study completion |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of response rates as measured by RECIST criteria | At Screening, Day 1 of all 28 day cycles beginning of each subsequent odd numbered cycle. |
| Evaluation of PSA laboratory values for response | Baseline and every visit through study termination |
| Evaluation of PD markers for HER2 and ErbB ligand levels | Measured at screening and Day 1 of all subsequent 28 days cycles and Day 15 of Cycle 1. |
Countries
United States
Outcome results
None listed