A Dose-escalation Study in Subjects With Advanced Malignancies
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/24/2017 |
| Start Date: | January 2010 |
| End Date: | January 2013 |
A Phase 1, Open-label, Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of INCB028060 in Subjects With Advanced Malignancies
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.
(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.
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
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