Clinical Trial: Safety Study of IPI-504 in Patients With Gastrointestinal Stromal Tumors (GIST) or Soft Tissue Sarcomas (STS)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 1, Safety Assessment and Pharmacokinetic Study of IPI-504 in Patients With Either Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) or Advanced or Metastatic Soft Tissue Sa

Brief Summary:

The primary objectives of the study are:

  • Determine the safety and maximum tolerated dose (MTD) of IPI-504 in GIST and STS patients who have failed prior therapies
  • Recommend a dose for subsequent studies of IPI-504

Detailed Summary: IPI-504 is a novel, water-soluble analog of 17-AAG and a potent inhibitor of Hsp90. Hsp90's role in the cell is to control the proper folding, function, and viability of various "client" proteins. Many of these client proteins (such as AKT, Her-2, Bcr-Abl, PDGFR-α, and c-Kit) are oncoproteins or important cell signaling proteins. In patients with GIST, mutations in the tyrosine kinase receptor Kit play a critical role in the pathogenesis of this disease. Inhibition of Kit signaling with the tyrosine kinase inhibitor Imatinib (IM) is a very effective treatment for GIST patients. However, new mutations arise in Kit conferring resistance to IM treatment which results in disease progression. Kit is a client protein of Hsp90 and is sensitive to IPI-504. In Soft Tissue Sarcomas, there may be genetic abnormalities that lead to the expression of certain proteins that drive the growth of cancer. These cancer-driving proteins may be stimulated by HSP90. This provides a scientific rationale for Phase 1 clinical testing of IPI-504 in patients with advanced GIST and STS who have failed prior therapies.
Sponsor: Infinity Pharmaceuticals, Inc.

Current Primary Outcome:

  • To determine the safety and maximum tolerated dose (MTD) of IPI-504 in GIST and STS patients who have failed prior therapies [ Time Frame: 18 months ]
  • To recommend a dose for subsequent studies of IPI-504 [ Time Frame: 18 months ]


Original Primary Outcome:

  • • To determine the safety and maximum tolerated dose (MTD) of IPI-504 in GIST patients who have failed prior therapies
  • • To recommend a dose for subsequent studies of IPI-504


Current Secondary Outcome:

  • To examine the pharmacokinetic (PK) parameters of IPI-504 in GIST and STS patients [ Time Frame: 18 months ]
  • To assess in a preliminary way the potential anti-tumor activity of IPI-504 in GIST and STS. [ Time Frame: 18 months ]
  • To explore potential pharmacodynamic (PD) markers of biologic activity of IPI-504 in GIST and STS. [ Time Frame: 18 months ]


Original Secondary Outcome:

  • • To examine the pharmacokinetic (PK) parameters of IPI-504 in GIST patients
  • • To assess in a preliminary way the potential anti-tumor activity of IPI-504 in GIST
  • • To explore potential pharmacodynamic (PD) markers of biologic activity of IPI-504 in GIST


Information By: Infinity Pharmaceuticals, Inc.

Dates:
Date Received: January 11, 2006
Date Started: December 2005
Date Completion:
Last Updated: January 5, 2011
Last Verified: January 2011