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NCT01348126 Clinical Trial

Study of Ganetespib (STA-9090) + Docetaxel in Advanced Non Small Cell Lung Cancer

Non-small Cell Lung Cancer Metastatic Clinical Trial

— GALAXY  

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01348126
Other study ID # 9090-08
Secondary ID
Status Terminated
Phase Phase 2/Phase 3
First received May 2, 2011
Last updated November 4, 2015
Start date May 2011
Est. completion date October 2015

Study information
Verified date November 2015
Source Synta Pharmaceuticals Corp.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsBosnia: Federal Ministry of HealthCanada: Health CanadaCroatia: Ministry of Health and Social CareCzech Republic: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical DevicesNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Medicines AgencyRussia: Pharmacological Committee, Ministry of HealthSerbia and Montenegro: Agency for Drugs and Medicinal DevicesSpain: Agencia Española de Medicamentos y Productos SanitariosUkraine: State Pharmacological Center - Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 385
Est. completion date October 2015
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Docetaxel
75 mg/m2 administered on Day 1 of a 3-week treatment cycle by 1-hour intravenous infusion
• Combination of ganetespib and docetaxel
Ganetespib 150 mg/m2 in combination with docetaxel 75 mg/m2. On Day 1 of each 3-week treatment cycle, ganetespib and docetaxel will be administered as separate 1-hour intravenous infusions. Ganetespib 150 mg/m2 will be administered again on Day 15 of each cycle.

Locations
Country Name City State
Belgium Synta Pharmaceuticals Investigative Site Brussels
Belgium Synta Pharmaceuticals Investigative Site Jette
Belgium Synta Pharmaceuticals Investigative Site Yvoir
Bosnia and Herzegovina Synta Pharmaceuticals Investigative Site Banja Luka
Bosnia and Herzegovina Synta Pharmaceuticals Investigative Site Mostar
Bosnia and Herzegovina Synta Pharmaceuticals Investgative Site Sarajevo
Bosnia and Herzegovina Synta Pharmaceuticals Investigative Site Sarajevo
Bosnia and Herzegovina Synta Pharmaceuticals Investigative Site Tuzla
Canada Synta Pharmaceuticals Investigative Site Hamilton
Canada Synta Pharmaceuticals Investigative Site Montreal
Canada Synta Pharmaceuticals Investigative Site Montreal
Canada Synta Pharmaceuticals Investigative Site Ottawa
Croatia Synta Pharmaceuticals Investigative Site Pula
Croatia Synta Pharmaceuticals Investigative Site Split
Croatia Synta Pharmaceuticals Investigative Site Zagreb
Czech Republic Synta Pharmaceuticals Investigative Site Prague
Germany Synta Pharmaceuticals Investigative Site Halle
Germany Synta Pharmaceuticals Investigative Site Hamburg
Germany Synta Pharmaceuticals Investigative Site Mainz
Germany Synta Pharmaceuticals Investigative Site Mannheim
Germany Synta Pharmaceuticals Investigative Site Offenbach
Poland Synta Pharmaceuticals Investigative Site Krakow
Poland Synta Pharmaceuticals Investigative Site Olsztyn
Poland Synta Pharmaceuticals Investigative Site Prabuty
Poland Synta Pharmaceuticals Investigative Site Szczecin
Romania Synta Pharmaceuticals Investigative Site Cluj - Napoca
Romania Synta Pharmaceuticals Investigative Site Cluj - Napoca
Romania Synta Pharmaceuticals Investigative Site Craiova
Romania Synta Pharmaceuticals Investigative Site Suceava
Russian Federation Synta Pharmaceuticals Investigative Site Kazan
Russian Federation Synta Pharmaceuticals Investigative Site Moscow
Russian Federation Synta Pharmaceuticals Investigative Site Moscow
Russian Federation Synta Pharmaceuticals Investigative Site Saint-Petersburg
Russian Federation Synta Pharmaceuticals Investigative Site Saint-Petersburg
Russian Federation Synta Pharmaceuticals Investigative Site Sochi
Russian Federation Synta Pharmaceuticals Investigative Site Voronezh
Serbia Synta Pharmaceuticals Investigative Site Belgrade
Serbia Synta Pharmaceuticals Investigative Site Sremska Kamenica
Spain Synta Pharmaceuticals Investigative Site Badalona
Spain Synta Pharmaceuticals Investigative Site Barcelona
Spain Synta Pharmaceuticals Investigative Site Madrid
United Kingdom Synta Pharmaceuticals Investigational Site Leicester
United Kingdom Synta Pharmaceuticals Investigational Site London
United Kingdom Synta Pharmaceuticals Investigative Site London
United Kingdom Synta Pharmaceuticals Investigational Site Sutton
United States Synta Pharmaceuticals Investigative Site Atlanta Georgia
United States Synta Pharmaceutials Investigative Site Boston Massachusetts
United States Synta Pharmaceuticals Investigative Site Chicago Illinois
United States Synta Pharmaceuticals Investigative Site Kettering Ohio
United States Synta Pharmaceuticals Investigative Site Portland Oregon
United States Synta Pharmaceuticals Investigative Site Santa Monica California
United States Synta Pharmaceuticals Investigative Site Tucson Arizona
United States Synta Pharmaceuticals Investigative Site Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Synta Pharmaceuticals Corp.

Countries where clinical trial is conducted

United States,  Belgium,  Bosnia and Herzegovina,  Canada,  Croatia,  Czech Republic,  Germany,  Poland,  Romania,  Russian Federation,  Serbia,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Progression-free survival in two co-primary populations 14 months No
Secondary Overall Response Rate ORR is the proportion of subjects who achieve tumor response 14 months No
Secondary Determine qualitative and quantitative toxicities AEs will be graded by NCI-CTC criteria. Tabulations of adverse events by frequency, relatedness and severity will be presented. Data will be presented by treatment arm and overall. No formal statistical analyses are planned. 14 months Yes
Secondary Determine plasma drug concentrations of the combination Assessed via measurement of Cmax levels. 14 months No
Secondary Evaluate Quality of Life As measured by the EORTC QLQ -C30 questionnaire 14 months No
Secondary Disease Control Rate Disease Control Rate is defined as the proportion of patients with best response, according to modified RECIST 1.1, of CR, PR or SD, where the SD must be for at least 6 weeks or 12 weeks. 14 months No
Secondary Tumor size change Tumor size changes from baseline to at least 6 and 12 weeks 14 months No
Secondary Overall survival 21 months No
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