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

December 6, 2012 updated by: Infinity Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale Comprehensive Cancer Center
    • Florida
      • Miami, Florida, United States, 33140
        • Mount Sinai Comprehensive Cancer Center
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Medical College of Georgia
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • Texas
      • Dallas, Texas, United States, 75201
        • Mary Crowley Cancer Research Centers - Medical City
      • Dallas, Texas, United States, 75246
        • Mary Crowley Cancer Research Centers - Baylor
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Infinity Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Lecia Sequist, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

January 31, 2007

First Submitted That Met QC Criteria

January 31, 2007

First Posted (Estimate)

February 2, 2007

Study Record Updates

Last Update Posted (Estimate)

December 10, 2012

Last Update Submitted That Met QC Criteria

December 6, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPI-504-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Cancer

Clinical Trials on IPI-504

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe