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

November 4, 2015 updated by: Synta Pharmaceuticals Corp.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

385

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Synta Pharmaceuticals Investigative Site
      • Jette, Belgium, 1090
        • Synta Pharmaceuticals Investigative Site
      • Yvoir, Belgium, 5530
        • Synta Pharmaceuticals Investigative Site
  • Bosnia and Herzegovina
      • Banja Luka, Bosnia and Herzegovina, 78000
        • Synta Pharmaceuticals Investigative Site
      • Mostar, Bosnia and Herzegovina, 88000
        • Synta Pharmaceuticals Investigative Site
      • Sarajevo, Bosnia and Herzegovina, 71000
        • Synta Pharmaceuticals Investgative Site
      • Sarajevo, Bosnia and Herzegovina, 71000
        • Synta Pharmaceuticals Investigative Site
      • Tuzla, Bosnia and Herzegovina, 75000
        • Synta Pharmaceuticals Investigative Site
  • Canada
      • Hamilton, Canada, L8V 5C2
        • Synta Pharmaceuticals Investigative Site
      • Montreal, Canada, H3A 1A1
        • Synta Pharmaceuticals Investigative Site
      • Montreal, Canada, H3G 1A4
        • Synta Pharmaceuticals Investigative Site
      • Ottawa, Canada, K1H 8L6
        • Synta Pharmaceuticals Investigative Site
  • Croatia
      • Pula, Croatia, 52100
        • Synta Pharmaceuticals Investigative Site
      • Split, Croatia, 21000
        • Synta Pharmaceuticals Investigative Site
      • Zagreb, Croatia, 10000
        • Synta Pharmaceuticals Investigative Site
  • Czech Republic
      • Prague, Czech Republic, 180 00
        • Synta Pharmaceuticals Investigative Site
  • Germany
      • Halle, Germany, 06120
        • Synta Pharmaceuticals Investigative Site
      • Hamburg, Germany, 22045
        • Synta Pharmaceuticals Investigative Site
      • Mainz, Germany, 55131
        • Synta Pharmaceuticals Investigative Site
      • Mannheim, Germany, 68167
        • Synta Pharmaceuticals Investigative Site
      • Offenbach, Germany, 63069
        • Synta Pharmaceuticals Investigative Site
  • Poland
      • Krakow, Poland, 31-115
        • Synta Pharmaceuticals Investigative Site
      • Olsztyn, Poland, 10-357
        • Synta Pharmaceuticals Investigative Site
      • Prabuty, Poland, 82-550
        • Synta Pharmaceuticals Investigative Site
      • Szczecin, Poland, 70-891
        • Synta Pharmaceuticals Investigative Site
  • Romania
      • Cluj - Napoca, Romania, 400015
        • Synta Pharmaceuticals Investigative Site
      • Cluj - Napoca, Romania, 400058
        • Synta Pharmaceuticals Investigative Site
      • Craiova, Romania, 200385
        • Synta Pharmaceuticals Investigative Site
      • Suceava, Romania, 720237
        • Synta Pharmaceuticals Investigative Site
  • Russian Federation
      • Kazan, Russian Federation, 420029
        • Synta Pharmaceuticals Investigative Site
      • Moscow, Russian Federation, 105229
        • Synta Pharmaceuticals Investigative Site
      • Moscow, Russian Federation, 115478
        • Synta Pharmaceuticals Investigative Site
      • Saint-Petersburg, Russian Federation, 194075
        • Synta Pharmaceuticals Investigative Site
      • Saint-Petersburg, Russian Federation, 197758
        • Synta Pharmaceuticals Investigative Site
      • Sochi, Russian Federation, 354057
        • Synta Pharmaceuticals Investigative Site
      • Voronezh, Russian Federation, 394000
        • Synta Pharmaceuticals Investigative Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Synta Pharmaceuticals Investigative Site
      • Sremska Kamenica, Serbia, 21204
        • Synta Pharmaceuticals Investigative Site
  • Spain
      • Badalona, Spain, 08916
        • Synta Pharmaceuticals Investigative Site
      • Barcelona, Spain, 08035
        • Synta Pharmaceuticals Investigative Site
      • Madrid, Spain, 28040
        • Synta Pharmaceuticals Investigative Site
  • United Kingdom
      • Leicester, United Kingdom, LE2 7HL
        • Synta Pharmaceuticals Investigational Site
      • London, United Kingdom, SE1 9RT
        • Synta Pharmaceuticals Investigative Site
      • London, United Kingdom, SW3 6JJ
        • Synta Pharmaceuticals Investigational Site
      • Sutton, United Kingdom, SM2 5PT
        • Synta Pharmaceuticals Investigational Site
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85715
        • Synta Pharmaceuticals Investigative Site
    • California
      • Santa Monica, California, United States, 90404
        • Synta Pharmaceuticals Investigative Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Synta Pharmaceuticals Investigative Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Synta Pharmaceuticals Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Synta Pharmaceutials Investigative Site
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Synta Pharmaceuticals Investigative Site
    • Ohio
      • Kettering, Ohio, United States, 45429
        • Synta Pharmaceuticals Investigative Site
    • Oregon
      • Portland, Oregon, United States, 97227
        • Synta Pharmaceuticals Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Single agent docetaxel
Drug: Docetaxel
75 mg/m2 administered on Day 1 of a 3-week treatment cycle by 1-hour intravenous infusion
Experimental: Combination of ganetespib and docetaxel
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival in two co-primary populations
Time Frame: 14 months
14 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate
Time Frame: 14 months
ORR is the proportion of subjects who achieve tumor response
14 months
Determine qualitative and quantitative toxicities
Time Frame: 14 months
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
Determine plasma drug concentrations of the combination
Time Frame: 14 months
Assessed via measurement of Cmax levels.
14 months
Evaluate Quality of Life
Time Frame: 14 months
As measured by the EORTC QLQ -C30 questionnaire
14 months
Disease Control Rate
Time Frame: 14 months
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
Tumor size change
Time Frame: 14 months
Tumor size changes from baseline to at least 6 and 12 weeks
14 months
Overall survival
Time Frame: 21 months
21 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Synta Pharmaceuticals Corp.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

May 2, 2011

First Submitted That Met QC Criteria

May 3, 2011

First Posted (Estimate)

May 5, 2011

Study Record Updates

Last Update Posted (Estimate)

November 5, 2015

Last Update Submitted That Met QC Criteria

November 4, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9090-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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