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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Hackensack University Medical Center The David Jurist Research Center
Hackensack, New Jersey, United States
St. Vincent's Comprehensive Cancer Center
New York, New York, United States
To determine the safety and maximum tolerated dose of IPI-504
Time frame: Following 1 cycle of treatment
Recommend a dose for subsequent studies of IPI-504
Time frame: Once MTD is reached
To examine the pharmacokinetic parameters of IPI-504
Time frame: During first dose first cycle of IPI-504
To evaluate the potential anti-tumor activity with standard markers of disease progression
Time frame: 1 cycle of treatment
To examine pharmacodynamic markers of biologic activity of IPI-504
Time frame: Cycle 1 of treatment
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