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

Sponsor

Synta Pharmaceuticals Corp. (Industry)

Overall Status

Completed

CT.gov ID

NCT01031225

Collaborator

(none)

113

Enrollment

Locations

Arm

Duration (Months)

5.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Drug: STA 9090	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

113 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Nov 1, 2009

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Feb 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Progression Free Survival rate [16 weeks]

Secondary Outcome Measures

Objective Response Rate, Disease Control Rate, Progression Free Survival, Overall Survival [18 months]
Safety and tolerability as measured by adverse event rates and laboratory evaluations [16 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

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