Advanced Cancer, Metastatic Cancer, Solid Tumor
Conditions
Keywords
Refractory, Advanced malignancies
Brief summary
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.
Interventions
DRUGINCB028060
10 mg and 50 mg capsules will be provided and dosed per the dosing schedule.
Sponsors
Novartis Pharmaceuticals
Incyte Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability will be the primary endpoint and will be assessed by monitoring the frequency, duration, and severity of AEs | Baseline and every 1-2 weeks based on protocol visit schedule until the end of study or early termination visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| c-MET inhibitory activity determined by the relationship between blood levels of INCB028060 and the percent inhibition of c-MET phosphorylation | Predose, specific hours post-dose on day and Day 15 of Cycle 1. | Samples will be collected at 0 (predose) and 2, 4, and 6 hours after dosing on Day 1 and Day 15 of Cycle 1 for subjects undergoing full PK analysis. |
Countries
United States
Outcome results
None listed