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

Sponsor:	Synta Pharmaceuticals Corp.
Information provided by:	Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:	NCT01031225

Purpose

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).

Condition	Intervention	Phase
Non Small Cell Lung Cancer	Drug: STA 9090	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by Synta Pharmaceuticals Corp.:

Primary Outcome Measures:

Progression Free Survival rate [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Objective Response Rate, Disease Control Rate, Progression Free Survival, Overall Survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Safety and tolerability as measured by adverse event rates and laboratory evaluations [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	88
Study Start Date:	November 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: STA 9090 STA-9090 IV infusion once per week for three consecutive weeks followed by a 1 week dose-free interval

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01031225

Contacts

Contact: Kelly Maslin	781-541-7150	kmaslin@syntapharma.com
Contact: Amy Gauger	781-541-7985	agauger@syntapharma.com

Locations

United States, Arizona
Arizona Cancer Center; University of Arizona	Recruiting
Tucson, Arizona, United States, 85724
Contact: Jeanette S Cardenas, BS, CCRC 520-694-9082
Principal Investigator: Linda Garland, MD
United States, Arkansas
Genesis Cancer Center	Recruiting
Hot Springs, Arkansas, United States, 71913
Contact: Lesia Gill, MAP 501-624-7700 lgill@genesiscancercenter.com
Principal Investigator: Timothy Webb, MD
United States, California
City of Hope Medical Center	Recruiting
Duarte, California, United States, 91010
Contact: Marianna Koczywas, MD, MD 626-256-4673
Principal Investigator: Marianna Koczywas, MD
Premiere Oncology	Recruiting
Santa Monica, California, United States, 90404
Contact 310-633-8400
United States, Georgia
Emory University- Winship Cancer Institute	Recruiting
Atlanta, Georgia, United States, 30322
Contact: Dorothy Breckner 404-778-4147 dorothy.breckner@emoryhealthcare.org
Principal Investigator: Suresh Ramalingam, MD
United States, Illinois
Rush University Medical Center	Recruiting
Chicago, Illinois, United States, 60612
Contact: Deborah Pach, RN 312-563-3347 Deborah_B_Pach@rush.edu
Principal Investigator: Philip Bonomi, MD
University of Chicago Medical Center	Recruiting
Chicago, Illinois, United States, 60637
Contact: Livia Szeto 773-834-0783 lszeto@medicine.bsd.uchicago.edu
Contact: Jennifer Shouldis 773-834-3137 jshouldi@medicine.bsd.uchicago.edu
Principal Investigator: Ravi Salgia, MD
United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center	Recruiting
Baltimore, Maryland, United States, 21231
Contact: Charles P Raines, CRNP, MSN 410-502-3696
Principal Investigator: Julie Brahmer, MD
United States, Massachusetts
Dana Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Joan Lucca, RN, NP-C 617-632-5403 jlucca@partners.org
Principal Investigator: Geoffrey Shapiro, MD, PhD
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Patricia Ostler, RN 617-724-7829 postler@partners.org
Sub-Investigator: Lecia Sequist, MD
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Kelly Masone 617-667-1925
Sub-Investigator: Mark Huberman, MD
United States, Nevada
Nevada Cancer Institute	Recruiting
Las Vegas, Nevada, United States, 89135
Contact: Christine Zades, MA 702-822-5456 czades@nvcancer.org
Principal Investigator: Lin-Chi Chen, MD
United States, New Jersey
Hackensack University Medical Center	Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Diane Den Bleyker, RN 201-336-8066 ddenbleyker@humed.com
Principal Investigator: Harry D Harper, MD
United States, North Carolina
University of North Carolina, Lineberger Comprehensive Cancer Center	Recruiting
Chapel Hill, North Carolina, United States, 27599
Principal Investigator: Mark Socinski, MD
Piedmont Hematology Oncology Associates	Recruiting
Winston Salem, North Carolina, United States, 27103
Contact: Don McCall 336-277-8887 dmccall@phoa.org
Principal Investigator: Eugene Paschold, MD
United States, Oregon
Oregon Health and Science University	Recruiting
Portland, Oregon, United States, 97239
Contact: OHSU Clinical Trials Hotline 503-494-1080
Principal Investigator: Alan Sandler, MD
United States, Pennsylvania
Penn State Hershey Cancer Institute	Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Rebecca Miller, RN, BS, OCN 717-531-1003 rmiller13@hmc.psu.edu
Principal Investigator: Chandra Belani, MD
United States, Tennessee
Vanderbilt-Ingram Cancer Center	Recruiting
Nashville, Tennessee, United States, 37212
Contact: Clinical Trials Information Program 800-811-8480
Principal Investigator: Leora Horn, MD
United States, Texas
UT Southwestern Medical Center	Recruiting
Dallas, Texas, United States, 75390
Contact: Rachael Skelton 214-648-4180 Rachael.Skelton@UTSouthwestern.edu
Principal Investigator: Joan Schiller, MD
United States, Washington
Swedish Medical Center	Recruiting
Seattle, Washington, United States, 98104
Contact: Justine Rees 206-215-6166 Justine.rees@swedish.org
Principal Investigator: Howard West, MD

Sponsors and Collaborators

Synta Pharmaceuticals Corp.

More Information

No publications provided

Responsible Party:	Kelly Maslin, Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:	NCT01031225 History of Changes
Other Study ID Numbers:	9090-06
Study First Received:	November 16, 2009
Last Updated:	May 23, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Synta Pharmaceuticals Corp.:

Synta
STA 9090
ganetespib)

Lung Cancer
Non Small Cell Lung Cancer
NSCLC

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms

Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 09, 2012