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.
Primary Outcome Measures:
- To determine the safety and maximum tolerated dose of IPI-504 [ Time Frame: Following 1 cycle of treatment ] [ Designated as safety issue: Yes ]
- Recommend a dose for subsequent studies of IPI-504 [ Time Frame: Once MTD is reached ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To examine the pharmacokinetic parameters of IPI-504 [ Time Frame: During first dose first cycle of IPI-504 ] [ Designated as safety issue: No ]
- To evaluate the potential anti-tumor activity with standard markers of disease progression [ Time Frame: 1 cycle of treatment ] [ Designated as safety issue: No ]
- To examine pharmacodynamic markers of biologic activity of IPI-504 [ Time Frame: Cycle 1 of treatment ] [ Designated as safety issue: No ]
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.