Clinical Trial: Phase I/II Safety Study of IPI-504 in Relapsed/Refractory Stage IIIb, or Stage IV Non-small Cell Lung Cancer (NSCLC)

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

Official Title: A Phase I/II Study to Investigate the Safety, Tolerability and Potential Activity of IPI-504 in Relapsed and / or Refractory Stage IIIb (With Malignant Pleural or Pericardial Eff

Brief Summary: The purpose of this study is to determine the safety, tolerability and maximum tolerated dose of IPI-504 in patients with non-small cell lung cancer (NSCLC). The study will examine how IPI-504 is absorbed, distributed, metabolized and eliminated by the body. The study will also evaluate the anti-tumor activity of IPI-504.

Detailed Summary: 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 maintaining the proper folding, function and viability of various "client proteins". Many of the client proteins stabilized by Hsp90 are oncoproteins and cell-signaling proteins important in cancer cell proliferation and cancer cell survival. This clinical trial will study the effects of IPI-504 in a molecularly defined sub-group of patients who carry client proteins found in non-small cell lung cancer.
Sponsor: Infinity Pharmaceuticals, Inc.

Current Primary Outcome: Determine potential anti-tumor activity of IPI-504 in molecularly defined sub-groups of patients by RECIST criteria [ Time Frame: Every 6 weeks ]

Original Primary Outcome:

  • Determine the safety and maximum tolerated dose
  • Recommend a dose for subsequent studies
  • Examine Pharmacokinetic (PK)properties


Current Secondary Outcome:

Original Secondary Outcome:

  • To determine potential anti-tumor activity
  • Explore pharmacodynamic (PD)markers


Information By: Infinity Pharmaceuticals, Inc.

Dates:
Date Received: January 31, 2007
Date Started: January 2007
Date Completion:
Last Updated: December 6, 2012
Last Verified: December 2012