search
Back to results

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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IPI-504
Sponsored by
Infinity Pharmaceuticals, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Lung Cancer, Cancer of the lung, Non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cedars-Sinai Medical Center
  • Yale Comprehensive Cancer Center
  • Mount Sinai Comprehensive Cancer Center
  • H. Lee Moffitt Cancer Center
  • Medical College of Georgia
  • Massachusetts General Hospital
  • Dana-Farber Cancer Institute
  • Hackensack University Medical Center
  • Mary Crowley Cancer Research Centers - Medical City
  • Mary Crowley Cancer Research Centers - Baylor
  • Seattle Cancer Care Alliance

Outcomes

Primary Outcome Measures

Determine potential anti-tumor activity of IPI-504 in molecularly defined sub-groups of patients by RECIST criteria

Secondary Outcome Measures

Full Information

First Posted
January 31, 2007
Last Updated
December 6, 2012
Sponsor
Infinity Pharmaceuticals, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00431015
Brief Title
Phase I/II Safety Study of IPI-504 in Relapsed/Refractory Stage IIIb, or Stage IV Non-small Cell Lung Cancer (NSCLC)
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Infinity Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung Cancer, Cancer of the lung, Non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
IPI-504
Intervention Description
IV Hsp90 inhibitor
Primary Outcome Measure Information:
Title
Determine potential anti-tumor activity of IPI-504 in molecularly defined sub-groups of patients by RECIST criteria
Time Frame
Every 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lecia Sequist, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Yale Comprehensive Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Mount Sinai Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
H. Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Medical College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Mary Crowley Cancer Research Centers - Medical City
City
Dallas
State/Province
Texas
ZIP/Postal Code
75201
Country
United States
Facility Name
Mary Crowley Cancer Research Centers - Baylor
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs