A Phase 1 Dose Escalation Safety/Tolerance Study of PPI-2458 in Subjects With Non-Hodgkin’s Lymphoma and Solid Tumors
The study will first determine the dose level that maximally inhibits MetAP2 in white blood
cells (WBC). Once this dose level is reached, the study will proceed into the next cohort
(dose level) to investigate the dose level that maximally inhibits MetAP2 in tumor tissue
biopsies. Free MetAP2 levels (WBC and/or tumor tissue) will be analyzed during the first
cycle (28 days) of treatment. Cohorts are expected to enroll every two cycles until the
maximum tolerated dose (MTD)is determined.
After the Initial Treatment Phase of two treatment cycles of PPI-2458, subjects may continue
into a Continuous Treatment Phase at the discretion of the Investigator. In order to be
eligible for the Continuous Treatment Phase of the protocol, subjects must have received
some benefit (e.g., stable disease) as assessed by the Investigator within the Initial
Treatment Phase and must continue to meet inclusion and exclusion criteria.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety will be determined by clinical adverse events, laboratory abnormalities, withdrawals due to adverse events, and drug-related neurotoxicities.
Paul Eder, MD
Principal Investigator
Dana-Farber Cancer Institute
United States: Food and Drug Administration
2458-04-01
NCT00100347
December 2004
July 2007
Name | Location |
---|---|
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Virginia Oncology Associates | Newport News, Virginia 23606 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
University of New Mexico | Albuquerque, New Mexico 87131 |
University of Texas, M.D. Anderson Cancer Center | Houston, Texas 77030 |
Columbia University Medical Center | New York, New York 10032 |
Universtiy of Maryland Marlene and Stewart Greenebaum Cancer Center | Baltimore, Maryland 21201 |