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Sponsored by: |
Infinity Pharmaceuticals |
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Information provided by: | Infinity Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00113204 |
This is a phase 1 clinical trial to find the safe, maximum tolerated dose of IPI-504 in patients with relapsed and/or relapsed, refractory multiple myeloma. This study will examine how IPI-504 is absorbed, distributed, metabolized, and eliminated by the body. The study will also evaluate potential anti-tumor activity of IPI-504.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma |
Drug: IPI-504 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study |
Official Title: | A Phase 1, Safety Assessment and Pharmacokinetic Study of IPI-504 in Patients With Relapsed, and Relapsed Refractory Multiple Myeloma |
Enrollment: | 18 |
Study Start Date: | June 2005 |
Study Completion Date: | March 2007 |
Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
IPI-504 is a novel small molecule inhibitor of heat shock protein 90 (Hsp90), an emerging and recently identified target for cancer therapy. Hsp90 is a protein chaperone that plays a central role in regulating protein homeostasis. Hsp90 regulates the stability of key proteins (called "client proteins") and keeps them in the appropriate three dimensional shape so they can perform their cellular functions. In addition, many of the proteins stabilized by Hsp90 are oncoproteins and cell-signaling proteins important in cancer cell proliferation and cancer cell survival. Thus Hsp90, a single molecular target that is a central integrator of multiple pathways important to cancer, is an ideal novel target for oncologic therapy. Selective inhibition of Hsp90 will affect multiple downstream mechanisms to disrupt tumor growth and selectively kill cancer cells. The anti-neoplastic effects of Hsp90 inhibition have been demonstrated both in vitro and in vivo for a variety of different hematologic and solid tumors including multiple myeloma.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | |
Baltimore, Maryland, United States, 21231 | |
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, New Jersey | |
Hackensack University Medical Center The David Jurist Research Center | |
Hackensack, New Jersey, United States, 07601 | |
United States, New York | |
St. Vincent's Comprehensive Cancer Center | |
New York, New York, United States, 10011 |
Principal Investigator: | Sundar Jagannath, MD | St. Vincent's Comprehensive Cancer Center |
Principal Investigator: | David S. Siegel, MD; Ph.D | Hackensack University Medical Center |
Principal Investigator: | Ivan Borrello, MD | Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center |
Principal Investigator: | Paul Richardson, MD | Dana-Farber Cancer Institute |
Study ID Numbers: | IPI-504-01 |
Study First Received: | June 6, 2005 |
Last Updated: | May 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00113204 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Multiple myeloma Relapsed Relapsed refractory |
Hematologic cancer hematologic disease plasma cells |
Immunoproliferative Disorders Hemorrhagic Disorders Hematologic Neoplasms Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders |
Vascular Diseases Paraproteinemias Lymphoproliferative Disorders Hemostatic Disorders Neoplasms, Plasma Cell Multiple Myeloma |
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Blood Protein Disorders Hematologic Diseases Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Neoplasms Hemorrhagic Disorders Cardiovascular Diseases Lymphoproliferative Disorders Neoplasms, Plasma Cell |