A Study of the HSP90 Inhibitor, STA-9090 in Subjects With Stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC)

September 18, 2014 updated by: Synta Pharmaceuticals Corp.

A Non-Randomized, Open-label, Multi-Center, Multi-Cohort Phase 2 Study Evaluating the Efficacy and Safety of STA-9090 in Subjects With Stage IIIB or IV Non-Small Cell Lung Cancer

This is a phase 2 study of the HSP90 inhibitor, STA-9090 (ganetespib) in subjects with stage IIIB or IV non-small cell lung cancer (NSCLC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Phase 2

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
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center; University of Arizona
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Genesis Cancer Center
    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Center
      • Santa Monica, California, United States, 90404
        • UCLA Health System
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University- Winship Cancer Institute
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
    • Nevada
      • Las Vegas, Nevada, United States, 89135
        • Nevada Cancer Institute
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina, Lineberger Comprehensive Cancer Center
      • Winston Salem, North Carolina, United States, 27103
        • Piedmont Hematology Oncology Associates
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Cancer Institute
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt-Ingram Cancer Center
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center

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 Stage IIIB (with pleural effusion) or Stage IV NSCLC with measurable disease by RECIST and evidence of progression
  • Availability of tissue for analysis
  • ECOG Performance Status 0 or 1
  • Adequate organ function as defined in the protocol.
  • Must be at least 18 years old and able and willing to sign a written informed consent document

Exclusion Criteria:

  • Poor venous access requiring an indwelling catheter for study drug administration
  • Women who are pregnant or lactating
  • Ventricular ejection fraction < or = to 55% at baseline
  • Any uncontrolled intercurrent illness

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: STA 9090
STA-9090 IV infusion once per week for three consecutive weeks followed by a 1 week dose-free interval

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival rate
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate, Disease Control Rate, Progression Free Survival, Overall Survival
Time Frame: 18 months
18 months
Safety and tolerability as measured by adverse event rates and laboratory evaluations
Time Frame: 16 months
16 months

Collaborators and Investigators

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

Sponsor

Synta Pharmaceuticals Corp.

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

November 1, 2009

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

November 16, 2009

First Submitted That Met QC Criteria

December 10, 2009

First Posted (Estimate)

December 14, 2009

Study Record Updates

Last Update Posted (Estimate)

September 19, 2014

Last Update Submitted That Met QC Criteria

September 18, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9090-06

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.

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