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

Non Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01031225
• Other study ID #: 9090-06
• Status: Completed
• Phase: Phase 2
• First received: November 16, 2009
• Last updated: September 18, 2014
• Start date: November 2009
• Est. completion date: February 2014

Study information

• Verified date: September 2014
• Source: Synta Pharmaceuticals Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: February 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Emory University- Winship Cancer Institute	Atlanta	Georgia
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	Johns Hopkins Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of North Carolina, Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Chicago Medical Center	Chicago	Illinois
United States	UT Southwestern Medical Center	Dallas	Texas
United States	City of Hope Medical Center	Duarte	California
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Penn State Hershey Cancer Institute	Hershey	Pennsylvania
United States	Genesis Cancer Center	Hot Springs	Arkansas
United States	Nevada Cancer Institute	Las Vegas	Nevada
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Oregon Health and Science University	Portland	Oregon
United States	UCLA Health System	Santa Monica	California
United States	Swedish Medical Center	Seattle	Washington
United States	Arizona Cancer Center; University of Arizona	Tucson	Arizona
United States	Piedmont Hematology Oncology Associates	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Synta Pharmaceuticals Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival rate		16 weeks	No
Secondary	Objective Response Rate, Disease Control Rate, Progression Free Survival, Overall Survival		18 months	No
Secondary	Safety and tolerability as measured by adverse event rates and laboratory evaluations		16 months	Yes