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

NCT ID: NCT01031225

Last Updated: 2014-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2014-02-28

Brief Summary

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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).

Detailed Description

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Conditions

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Non Small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

STA 9090

Intervention Type DRUG

STA-9090 IV infusion once per week for three consecutive weeks followed by a 1 week dose-free interval

Interventions

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STA 9090

STA-9090 IV infusion once per week for three consecutive weeks followed by a 1 week dose-free interval

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Synta Pharmaceuticals Corp.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Arizona Cancer Center; University of Arizona

Tucson, Arizona, United States

Site Status

Genesis Cancer Center

Hot Springs, Arkansas, United States

Site Status

City of Hope Medical Center

Duarte, California, United States

Site Status

UCLA Health System

Santa Monica, California, United States

Site Status

University of Colorado Cancer Center

Aurora, Colorado, United States

Site Status

Emory University- Winship Cancer Institute

Atlanta, Georgia, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Nevada Cancer Institute

Las Vegas, Nevada, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

University of North Carolina, Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Site Status

Piedmont Hematology Oncology Associates

Winston-Salem, North Carolina, United States

Site Status

Oregon Health and Science University

Portland, Oregon, United States

Site Status

Penn State Hershey Cancer Institute

Hershey, Pennsylvania, United States

Site Status

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status

Swedish Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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9090-06

Identifier Type: -

Identifier Source: org_study_id

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