Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Nereus Pharmaceuticals, Inc. |
---|---|
Information provided by: | Nereus Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00396864 |
This is a Phase 1 clinical trial examining the safety, pharmacokinetics and pharmacodynamics of escalating doses of the proteasome inhibitor NPI-0052 in patients with refractory solid tumors or lymphomas. By inhibiting proteasomes NPI-0052 prevents the breakdown of proteins involved in signal transduction, which blocks growth and survival in cancer cells.
Condition | Intervention | Phase |
---|---|---|
Cancer Solid Tumors Lymphomas |
Drug: NPI-0052 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Solid Tumor Malignancies or Refractory Lymphoma |
Estimated Enrollment: | 50 |
Study Start Date: | May 2006 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Advanced Solid Tumor Malignancies and Refractory Lymphoma
|
Drug: NPI-0052
IV injection, three times every 28 days, escalating dosing cohorts
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Angie Longenecker, RN | 858-200-8354 | alongenecker@nereuspharm.com |
Contact: Matthew A. Spear, M.D. - Chief Medical Officer, Nereus Pharmaceuticals |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10021 | |
Contact: Michelle Maziarz 646-227-2125 | |
Principal Investigator: Carol Aghajanian, M.D. | |
Sub-Investigator: Paul Hamlin, M.D. | |
United States, Texas | |
Univ. of Texas MD Anderson Cancer Center | Recruiting |
Houston,, Texas, United States, 77030 | |
Contact: Debra Williams 713-792-1871 | |
Principal Investigator: Razelle Kurzrock, M.D. | |
Sub-Investigator: Anas Younes, M.D. |
Study Director: | Alison Hannah, M.D. | Nereus Pharmaceuticals |
Responsible Party: | Nereus Pharmaceuticals, Inc. ( Matthew A. Spear MD/Chief Medical Officer ) |
Study ID Numbers: | NPI-0052-100 |
Study First Received: | November 6, 2006 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00396864 |
Health Authority: | United States: Food and Drug Administration |
Lymphatic Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |