A First-in-Human Single Ascending Dose Study of TRX518 in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma or Other Solid Tumor Malignancies
The following visits are required:
- Screening visit: 1 to 2 appointments will be conducted to determine eligibility. All or
most requirements can be determined from the patient's medical records.
- Baseline visit: within 7 days of the planned study dosing day a baseline physical exam,
blood tests and electrocardiogram will be obtained.
- Dosing visit: 1 outpatient visit where TRX518 will be given IV over 1 hour followed by
4 hours of observation and some repeat blood tests.
- Follow up visits: 5 outpatient visits following dosing at 1, 8 and 15 days and 3, 6,
12, and 18 weeks post dosing
- Long term follow-up: 4 brief assessments by medical record review and/or telephone
contact at 6, 12, 18, and 24 months post dosing.
- The core study duration is 18 weeks. The follow-up study duration is 24 months.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
1. Adverse events (Safety)
Any adverse change in health or side effect from the initiation of the study drug dose through completion or premature withdrawal.
18 weeks
Yes
Principle Investigator: Jedd Wolchok, MD, PhD
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
TRX518-001
NCT01239134
October 2010
December 2014
Name | Location |
---|---|
Melanoma and Sarcoma Service / Memorial Sloan Kettering Cancer Center | New York, New York 10065 |