search
Back to results

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

Primary Purpose

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

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Docetaxel
Combination of ganetespib and docetaxel
Sponsored by
Synta Pharmaceuticals Corp.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer Stage IIIB focused on measuring Advanced non-small cell lung cancer, NSCLC, Lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceutials Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investgative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigational Site
  • Synta Pharmaceuticals Investigative Site
  • Synta Pharmaceuticals Investigational Site
  • Synta Pharmaceuticals Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Single agent docetaxel

Combination of ganetespib and docetaxel

Arm Description

Outcomes

Primary Outcome Measures

Progression-free survival in two co-primary populations

Secondary Outcome Measures

Overall Response Rate
ORR is the proportion of subjects who achieve tumor response
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.
Determine plasma drug concentrations of the combination
Assessed via measurement of Cmax levels.
Evaluate Quality of Life
As measured by the EORTC QLQ -C30 questionnaire
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.
Tumor size change
Tumor size changes from baseline to at least 6 and 12 weeks
Overall survival

Full Information

First Posted
May 2, 2011
Last Updated
November 4, 2015
Sponsor
Synta Pharmaceuticals Corp.
search

1. Study Identification

Unique Protocol Identification Number
NCT01348126
Brief Title
Study of Ganetespib (STA-9090) + Docetaxel in Advanced Non Small Cell Lung Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Study Start Date
May 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Synta Pharmaceuticals Corp.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
385 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single agent docetaxel
Arm Type
Active Comparator
Arm Title
Combination of ganetespib and docetaxel
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
75 mg/m2 administered on Day 1 of a 3-week treatment cycle by 1-hour intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Combination of ganetespib and docetaxel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-free survival in two co-primary populations
Time Frame
14 months
Secondary Outcome Measure Information:
Title
Overall Response Rate
Description
ORR is the proportion of subjects who achieve tumor response
Time Frame
14 months
Title
Determine qualitative and quantitative toxicities
Description
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.
Time Frame
14 months
Title
Determine plasma drug concentrations of the combination
Description
Assessed via measurement of Cmax levels.
Time Frame
14 months
Title
Evaluate Quality of Life
Description
As measured by the EORTC QLQ -C30 questionnaire
Time Frame
14 months
Title
Disease Control Rate
Description
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.
Time Frame
14 months
Title
Tumor size change
Description
Tumor size changes from baseline to at least 6 and 12 weeks
Time Frame
14 months
Title
Overall survival
Time Frame
21 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Synta Pharmaceuticals Investigative Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Synta Pharmaceuticals Investigative Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Synta Pharmaceuticals Investigative Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Synta Pharmaceuticals Investigative Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Synta Pharmaceutials Investigative Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Synta Pharmaceuticals Investigative Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Synta Pharmaceuticals Investigative Site
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Synta Pharmaceuticals Investigative Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Synta Pharmaceuticals Investigative Site
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Synta Pharmaceuticals Investigative Site
City
Jette
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Synta Pharmaceuticals Investigative Site
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Synta Pharmaceuticals Investigative Site
City
Banja Luka
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
Synta Pharmaceuticals Investigative Site
City
Mostar
ZIP/Postal Code
88000
Country
Bosnia and Herzegovina
Facility Name
Synta Pharmaceuticals Investgative Site
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
Synta Pharmaceuticals Investigative Site
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
Synta Pharmaceuticals Investigative Site
City
Tuzla
ZIP/Postal Code
75000
Country
Bosnia and Herzegovina
Facility Name
Synta Pharmaceuticals Investigative Site
City
Hamilton
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Synta Pharmaceuticals Investigative Site
City
Montreal
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Synta Pharmaceuticals Investigative Site
City
Montreal
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Synta Pharmaceuticals Investigative Site
City
Ottawa
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Synta Pharmaceuticals Investigative Site
City
Pula
ZIP/Postal Code
52100
Country
Croatia
Facility Name
Synta Pharmaceuticals Investigative Site
City
Split
ZIP/Postal Code
21000
Country
Croatia
Facility Name
Synta Pharmaceuticals Investigative Site
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Synta Pharmaceuticals Investigative Site
City
Prague
ZIP/Postal Code
180 00
Country
Czech Republic
Facility Name
Synta Pharmaceuticals Investigative Site
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Synta Pharmaceuticals Investigative Site
City
Hamburg
ZIP/Postal Code
22045
Country
Germany
Facility Name
Synta Pharmaceuticals Investigative Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Synta Pharmaceuticals Investigative Site
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Synta Pharmaceuticals Investigative Site
City
Offenbach
ZIP/Postal Code
63069
Country
Germany
Facility Name
Synta Pharmaceuticals Investigative Site
City
Krakow
ZIP/Postal Code
31-115
Country
Poland
Facility Name
Synta Pharmaceuticals Investigative Site
City
Olsztyn
ZIP/Postal Code
10-357
Country
Poland
Facility Name
Synta Pharmaceuticals Investigative Site
City
Prabuty
ZIP/Postal Code
82-550
Country
Poland
Facility Name
Synta Pharmaceuticals Investigative Site
City
Szczecin
ZIP/Postal Code
70-891
Country
Poland
Facility Name
Synta Pharmaceuticals Investigative Site
City
Cluj - Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Synta Pharmaceuticals Investigative Site
City
Cluj - Napoca
ZIP/Postal Code
400058
Country
Romania
Facility Name
Synta Pharmaceuticals Investigative Site
City
Craiova
ZIP/Postal Code
200385
Country
Romania
Facility Name
Synta Pharmaceuticals Investigative Site
City
Suceava
ZIP/Postal Code
720237
Country
Romania
Facility Name
Synta Pharmaceuticals Investigative Site
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Synta Pharmaceuticals Investigative Site
City
Moscow
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
Synta Pharmaceuticals Investigative Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Synta Pharmaceuticals Investigative Site
City
Saint-Petersburg
ZIP/Postal Code
194075
Country
Russian Federation
Facility Name
Synta Pharmaceuticals Investigative Site
City
Saint-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Synta Pharmaceuticals Investigative Site
City
Sochi
ZIP/Postal Code
354057
Country
Russian Federation
Facility Name
Synta Pharmaceuticals Investigative Site
City
Voronezh
ZIP/Postal Code
394000
Country
Russian Federation
Facility Name
Synta Pharmaceuticals Investigative Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Synta Pharmaceuticals Investigative Site
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
Synta Pharmaceuticals Investigative Site
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Synta Pharmaceuticals Investigative Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Synta Pharmaceuticals Investigative Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Synta Pharmaceuticals Investigational Site
City
Leicester
ZIP/Postal Code
LE2 7HL
Country
United Kingdom
Facility Name
Synta Pharmaceuticals Investigative Site
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Synta Pharmaceuticals Investigational Site
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Synta Pharmaceuticals Investigational Site
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs