Clinical trial NCT01348126: Study of Ganetespib (STA-9090) + Docetaxel in Advanced Non Small Cell Lung Cancer
Official title: A Randomized, Phase IIB/III Study of Ganetespib (STA-9090) in Combination With Docetaxel Versus Docetaxel Alone in Subjects With Stage IIIb or IV Non-Small-Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Non-small Cell Lung Cancer Stage IIIB
Non-small Cell Lung Cancer Stage IV
Non-small Cell Lung Cancer Metastatic
Keywords: Advanced non-small cell lung cancer
NSCLC
Lung cancer
Lead sponsor: Synta Pharmaceuticals Corp.
Sponsor class: INDUSTRY
First posted: 2011-05-05
Enrollment: 385
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether combining ganetespib (STA-9090) with docetaxel is more effective than docetaxel alone in the treatment of subjects with advanced non-small cell lung cancer.

Detailed description: Preliminary signals of clinical activity of ganetespib as a single agent have been observed in NSCLC. A novel approach to treatment of NSCLC is the combination of Hsp90 inhibitors, such as ganetespib, and taxanes. Such combinations have shown potential for synergy in preclinical and clinical evaluations with other Hsp90 inhibitors. Preclinical studies with ganetespib and taxanes have indicated that the combination of these drugs was more effective than either drug alone at inducing cell death, and an ongoing phase 1 study indicates that the combination is well tolerated and warrants systematic evaluation in a larger study.

Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of NSCLC
* Stage IIIB or IV NSCLC
* ECOG Performance Status 0 or 1
* Prior therapy defined as 1 prior systemic therapy for advanced disease
* measurable disease
* Radiologic evidence of disease progression following most recent prior treatment.
* Adequate hematologic, hepatic, renal function

Exclusion Criteria:

* Active or untreated CNS metastases
* Active malignancies other than NSCLC within the last 5 years with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin
* Serious cardiac illness or medical conditions
* Pregnant or lactating women
* Uncontrolled intercurrent illness

Primary outcomes:
measure: Progression-free survival in two co-primary populations
timeFrame: 14 months
Secondary outcomes:
measure: Overall Response Rate
timeFrame: 14 months
measure: Determine qualitative and quantitative toxicities
timeFrame: 14 months
measure: Determine plasma drug concentrations of the combination
timeFrame: 14 months
measure: Evaluate Quality of Life
timeFrame: 14 months
measure: Disease Control Rate
timeFrame: 14 months
measure: Tumor size change
timeFrame: 14 months
measure: Overall survival
timeFrame: 21 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Synta Pharmaceuticals Investigative Site
state: Arizona
city: Santa Monica
country: United States
facility: Synta Pharmaceuticals Investigative Site
state: California
city: Atlanta
country: United States
facility: Synta Pharmaceuticals Investigative Site
state: Georgia
city: Chicago
country: United States
facility: Synta Pharmaceuticals Investigative Site
state: Illinois
city: Boston
country: United States
facility: Synta Pharmaceutials Investigative Site
state: Massachusetts
city: Winston-Salem
country: United States
facility: Synta Pharmaceuticals Investigative Site
state: North Carolina
city: Kettering
country: United States
facility: Synta Pharmaceuticals Investigative Site
state: Ohio
city: Portland
country: United States
facility: Synta Pharmaceuticals Investigative Site
state: Oregon
city: Brussels
country: Belgium
facility: Synta Pharmaceuticals Investigative Site
city: Jette
country: Belgium
facility: Synta Pharmaceuticals Investigative Site
city: Yvoir
country: Belgium
facility: Synta Pharmaceuticals Investigative Site
city: Banja Luka
country: Bosnia and Herzegovina
facility: Synta Pharmaceuticals Investigative Site
city: Mostar
country: Bosnia and Herzegovina
facility: Synta Pharmaceuticals Investigative Site
city: Sarajevo
country: Bosnia and Herzegovina
facility: Synta Pharmaceuticals Investgative Site
city: Sarajevo
country: Bosnia and Herzegovina
facility: Synta Pharmaceuticals Investigative Site
city: Tuzla
country: Bosnia and Herzegovina
facility: Synta Pharmaceuticals Investigative Site
city: Hamilton
country: Canada
facility: Synta Pharmaceuticals Investigative Site
city: Montreal
country: Canada
facility: Synta Pharmaceuticals Investigative Site
city: Montreal
country: Canada
facility: Synta Pharmaceuticals Investigative Site
city: Ottawa
country: Canada
facility: Synta Pharmaceuticals Investigative Site
city: Pula
country: Croatia
facility: Synta Pharmaceuticals Investigative Site
city: Split
country: Croatia
facility: Synta Pharmaceuticals Investigative Site
city: Zagreb
country: Croatia
facility: Synta Pharmaceuticals Investigative Site
city: Prague
country: Czech Republic
facility: Synta Pharmaceuticals Investigative Site
city: Halle
country: Germany
facility: Synta Pharmaceuticals Investigative Site
city: Hamburg
country: Germany
facility: Synta Pharmaceuticals Investigative Site
city: Mainz
country: Germany
facility: Synta Pharmaceuticals Investigative Site
city: Mannheim
country: Germany
facility: Synta Pharmaceuticals Investigative Site
city: Offenbach
country: Germany
facility: Synta Pharmaceuticals Investigative Site
city: Krakow
country: Poland
facility: Synta Pharmaceuticals Investigative Site
city: Olsztyn
country: Poland
facility: Synta Pharmaceuticals Investigative Site
city: Prabuty
country: Poland
facility: Synta Pharmaceuticals Investigative Site
city: Szczecin
country: Poland
facility: Synta Pharmaceuticals Investigative Site
city: Cluj - Napoca
country: Romania
facility: Synta Pharmaceuticals Investigative Site
city: Cluj - Napoca
country: Romania
facility: Synta Pharmaceuticals Investigative Site
city: Craiova
country: Romania
facility: Synta Pharmaceuticals Investigative Site
city: Suceava
country: Romania
facility: Synta Pharmaceuticals Investigative Site
city: Kazan
country: Russian Federation
facility: Synta Pharmaceuticals Investigative Site
city: Moscow
country: Russian Federation
facility: Synta Pharmaceuticals Investigative Site
city: Moscow
country: Russian Federation
facility: Synta Pharmaceuticals Investigative Site
city: Saint-Petersburg
country: Russian Federation
facility: Synta Pharmaceuticals Investigative Site
city: Saint-Petersburg
country: Russian Federation
facility: Synta Pharmaceuticals Investigative Site
city: Sochi
country: Russian Federation
facility: Synta Pharmaceuticals Investigative Site
city: Voronezh
country: Russian Federation
facility: Synta Pharmaceuticals Investigative Site
city: Belgrade
country: Serbia
facility: Synta Pharmaceuticals Investigative Site
city: Sremska Kamenica
country: Serbia
facility: Synta Pharmaceuticals Investigative Site
city: Badalona
country: Spain
facility: Synta Pharmaceuticals Investigative Site
city: Barcelona
country: Spain
facility: Synta Pharmaceuticals Investigative Site
city: Madrid
country: Spain
facility: Synta Pharmaceuticals Investigative Site
city: Leicester
country: United Kingdom
facility: Synta Pharmaceuticals Investigational Site
city: London
country: United Kingdom
facility: Synta Pharmaceuticals Investigative Site
city: London
country: United Kingdom
facility: Synta Pharmaceuticals Investigational Site
city: Sutton
country: United Kingdom
facility: Synta Pharmaceuticals Investigational Site
Study officials:
References: