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

Lung Cancer Clinical Trial

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 Effusion), or Stage IV NSCLC Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00431015
• Other study ID #: IPI-504-03
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 31, 2007
• Last updated: December 6, 2012
• Start date: January 2007
• Est. completion date: December 2011

Study information

• Verified date: December 2012
• Source: Infinity Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pathologically confirmed diagnosis of a Stage IIIb (with malignant pleural or pericardial effusion) or Stage IV NSCLC

• Measurable disease by RECIST criteria.

Exclusion Criteria:

• Treatment for NSCLC with any approved or investigational product within 2 weeks of the start of IPI-504 treatment for any small molecule therapy; within 4 weeks of the start of IPI-504 treatment for any biologic or any conventional chemotherapy.

• Inadequate hematologic or renal or hepatic function

• Previous treatment with 17-AAG, DMAG or other known Hsp90 inhibitor.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• IPI-504
IV Hsp90 inhibitor

Locations

Country	Name	City	State
United States	Medical College of Georgia	Augusta	Georgia
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Mary Crowley Cancer Research Centers - Baylor	Dallas	Texas
United States	Mary Crowley Cancer Research Centers - Medical City	Dallas	Texas
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Mount Sinai Comprehensive Cancer Center	Miami	Florida
United States	Yale Comprehensive Cancer Center	New Haven	Connecticut
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	H. Lee Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Infinity Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine potential anti-tumor activity of IPI-504 in molecularly defined sub-groups of patients by RECIST criteria		Every 6 weeks	No