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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
385

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Progression-free survival in two co-primary populations
Time Frame: 14 months
14 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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