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

NCT ID: NCT01348126

Last Updated: 2015-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

385 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2015-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer Metastatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single agent docetaxel

Group Type ACTIVE_COMPARATOR

Docetaxel

Intervention Type DRUG

75 mg/m2 administered on Day 1 of a 3-week treatment cycle by 1-hour intravenous infusion

Combination of ganetespib and docetaxel

Group Type EXPERIMENTAL

Combination of ganetespib and docetaxel

Intervention Type DRUG

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.

Interventions

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Docetaxel

75 mg/m2 administered on Day 1 of a 3-week treatment cycle by 1-hour intravenous infusion

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Synta Pharmaceuticals Corp.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Synta Pharmaceuticals Investigative Site

Tucson, Arizona, United States

Site Status

Synta Pharmaceuticals Investigative Site

Santa Monica, California, United States

Site Status

Synta Pharmaceuticals Investigative Site

Atlanta, Georgia, United States

Site Status

Synta Pharmaceuticals Investigative Site

Chicago, Illinois, United States

Site Status

Synta Pharmaceutials Investigative Site

Boston, Massachusetts, United States

Site Status

Synta Pharmaceuticals Investigative Site

Winston-Salem, North Carolina, United States

Site Status

Synta Pharmaceuticals Investigative Site

Kettering, Ohio, United States

Site Status

Synta Pharmaceuticals Investigative Site

Portland, Oregon, United States

Site Status

Synta Pharmaceuticals Investigative Site

Brussels, , Belgium

Site Status

Synta Pharmaceuticals Investigative Site

Jette, , Belgium

Site Status

Synta Pharmaceuticals Investigative Site

Yvoir, , Belgium

Site Status

Synta Pharmaceuticals Investigative Site

Banja Luka, , Bosnia and Herzegovina

Site Status

Synta Pharmaceuticals Investigative Site

Mostar, , Bosnia and Herzegovina

Site Status

Synta Pharmaceuticals Investgative Site

Sarajevo, , Bosnia and Herzegovina

Site Status

Synta Pharmaceuticals Investigative Site

Sarajevo, , Bosnia and Herzegovina

Site Status

Synta Pharmaceuticals Investigative Site

Tuzla, , Bosnia and Herzegovina

Site Status

Synta Pharmaceuticals Investigative Site

Hamilton, , Canada

Site Status

Synta Pharmaceuticals Investigative Site

Montreal, , Canada

Site Status

Synta Pharmaceuticals Investigative Site

Montreal, , Canada

Site Status

Synta Pharmaceuticals Investigative Site

Ottawa, , Canada

Site Status

Synta Pharmaceuticals Investigative Site

Pula, , Croatia

Site Status

Synta Pharmaceuticals Investigative Site

Split, , Croatia

Site Status

Synta Pharmaceuticals Investigative Site

Zagreb, , Croatia

Site Status

Synta Pharmaceuticals Investigative Site

Prague, , Czechia

Site Status

Synta Pharmaceuticals Investigative Site

Halle, , Germany

Site Status

Synta Pharmaceuticals Investigative Site

Hamburg, , Germany

Site Status

Synta Pharmaceuticals Investigative Site

Mainz, , Germany

Site Status

Synta Pharmaceuticals Investigative Site

Mannheim, , Germany

Site Status

Synta Pharmaceuticals Investigative Site

Offenbach, , Germany

Site Status

Synta Pharmaceuticals Investigative Site

Krakow, , Poland

Site Status

Synta Pharmaceuticals Investigative Site

Olsztyn, , Poland

Site Status

Synta Pharmaceuticals Investigative Site

Prabuty, , Poland

Site Status

Synta Pharmaceuticals Investigative Site

Szczecin, , Poland

Site Status

Synta Pharmaceuticals Investigative Site

Cluj-Napoca, , Romania

Site Status

Synta Pharmaceuticals Investigative Site

Cluj-Napoca, , Romania

Site Status

Synta Pharmaceuticals Investigative Site

Craiova, , Romania

Site Status

Synta Pharmaceuticals Investigative Site

Suceava, , Romania

Site Status

Synta Pharmaceuticals Investigative Site

Kazan', , Russia

Site Status

Synta Pharmaceuticals Investigative Site

Moscow, , Russia

Site Status

Synta Pharmaceuticals Investigative Site

Moscow, , Russia

Site Status

Synta Pharmaceuticals Investigative Site

Saint Petersburg, , Russia

Site Status

Synta Pharmaceuticals Investigative Site

Saint Petersburg, , Russia

Site Status

Synta Pharmaceuticals Investigative Site

Sochi, , Russia

Site Status

Synta Pharmaceuticals Investigative Site

Voronezh, , Russia

Site Status

Synta Pharmaceuticals Investigative Site

Belgrade, , Serbia

Site Status

Synta Pharmaceuticals Investigative Site

Kamenitz, , Serbia

Site Status

Synta Pharmaceuticals Investigative Site

Badalona, , Spain

Site Status

Synta Pharmaceuticals Investigative Site

Barcelona, , Spain

Site Status

Synta Pharmaceuticals Investigative Site

Madrid, , Spain

Site Status

Synta Pharmaceuticals Investigational Site

Leicester, , United Kingdom

Site Status

Synta Pharmaceuticals Investigative Site

London, , United Kingdom

Site Status

Synta Pharmaceuticals Investigational Site

London, , United Kingdom

Site Status

Synta Pharmaceuticals Investigational Site

Sutton, , United Kingdom

Site Status

Countries

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United States Belgium Bosnia and Herzegovina Canada Croatia Czechia Germany Poland Romania Russia Serbia Spain United Kingdom

Other Identifiers

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9090-08

Identifier Type: -

Identifier Source: org_study_id

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