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Sponsored by: |
PRAECIS Pharmaceuticals Inc. |
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Information provided by: | PRAECIS Pharmaceuticals Inc. |
ClinicalTrials.gov Identifier: | NCT00100347 |
The purpose of this multi-center, open-label, escalating dose study is to assess the safety and tolerability of PPI-2458 in subjects with Non-Hodgkin's Lymphoma (NHL)and solid tumors. Subjects will be treated every other day (QOD) with PPI-2458 while being monitored closely for adverse events.
Condition | Intervention | Phase |
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Non-Hodgkin's Lymphoma, Solid Tumors |
Drug: PPI-2458 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase 1 Dose Escalation Safety/Tolerance Study of PPI-2458 in Subjects With Non-Hodgkin’s Lymphoma and Solid Tumors |
Enrollment: | 45 |
Study Start Date: | December 2004 |
Study Completion Date: | July 2007 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
Universtiy of Maryland Marlene and Stewart Greenebaum Cancer Center | |
Baltimore, Maryland, United States, 21201 | |
United States, Massachusetts | |
Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
United States, New Mexico | |
University of New Mexico | |
Albuquerque, New Mexico, United States, 87131 | |
United States, New York | |
Columbia University Medical Center | |
New York, New York, United States, 10032 | |
United States, Texas | |
University of Texas, M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
United States, Virginia | |
Virginia Oncology Associates | |
Norfolk, Virginia, United States, 23502 |
Principal Investigator: | Paul Eder, MD | Dana-Farber Cancer Institute |
Study ID Numbers: | 2458-04-01 |
Study First Received: | December 29, 2004 |
Last Updated: | July 23, 2007 |
ClinicalTrials.gov Identifier: | NCT00100347 |
Health Authority: | United States: Food and Drug Administration |
non-Hodgkin lymphoma non-Hodgkin’s lymphoma NHL MetAP2 Solid Tumors |
Lymphatic Diseases Immunoproliferative Disorders Lymphoma, small cleaved-cell, diffuse |
Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |