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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Synta Pharmaceuticals Corp..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:
NCT01348126
First received: May 2, 2011
Last updated: May 13, 2013
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Non-small Cell Lung Cancer Stage IIIB
Non-small Cell Lung Cancer Stage IV
Non-small Cell Lung Cancer Metastatic
Drug: Docetaxel
Drug: Combination of ganetespib and docetaxel
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Synta Pharmaceuticals Corp.:

Primary Outcome Measures:
  • Progression-free survival in two co-primary populations [ Time Frame: 14 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Response Rate [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    ORR is the proportion of subjects who achieve tumor response

  • Determine qualitative and quantitative toxicities [ Time Frame: 14 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    Assessed via measurement of Cmax levels.

  • Evaluate Quality of Life [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    As measured by the EORTC QLQ -C30 questionnaire

  • Disease Control Rate [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    Tumor size changes from baseline to at least 6 and 12 weeks

  • Overall survival [ Time Frame: 21 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: May 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01348126

  Hide Study Locations
Locations
United States, Arizona
Synta Pharmaceuticals Investigative Site
Tucson, Arizona, United States, 85715
United States, California
Synta Pharmaceuticals Investigative Site
Santa Monica, California, United States, 90404
United States, Georgia
Synta Pharmaceuticals Investigative Site
Atlanta, Georgia, United States, 30322
United States, Illinois
Synta Pharmaceuticals Investigative Site
Chicago, Illinois, United States, 60637
United States, Massachusetts
Synta Pharmaceutials Investigative Site
Boston, Massachusetts, United States, 02215
United States, North Carolina
Synta Pharmaceuticals Investigative Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Synta Pharmaceuticals Investigative Site
Kettering, Ohio, United States, 45429
United States, Oregon
Synta Pharmaceuticals Investigative Site
Portland, Oregon, United States, 97227
Belgium
Synta Pharmaceuticals Investigative Site
Brussels, Belgium, 1200
Synta Pharmaceuticals Investigative Site
Jette, Belgium, 1090
Synta Pharmaceuticals Investigative Site
Yvoir, Belgium, 5530
Bosnia and Herzegovina
Synta Pharmaceuticals Investigative Site
Banja Luka, Bosnia and Herzegovina, 78000
Synta Pharmaceuticals Investigative Site
Mostar, Bosnia and Herzegovina, 88000
Synta Pharmaceuticals Investgative Site
Sarajevo, Bosnia and Herzegovina, 71000
Synta Pharmaceuticals Investigative Site
Sarajevo, Bosnia and Herzegovina, 71000
Synta Pharmaceuticals Investigative Site
Tuzla, Bosnia and Herzegovina, 75000
Canada
Synta Pharmaceuticals Investigative Site
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
Croatia
Synta Pharmaceuticals Investigative Site
Pula, Croatia, 52100
Synta Pharmaceuticals Investigative Site
Split, Croatia, 21000
Synta Pharmaceuticals Investigative Site
Zagreb, Croatia, 10000
Czech Republic
Synta Pharmaceuticals Investigative Site
Prague, Czech Republic, 180 00
Germany
Synta Pharmaceuticals Investigative Site
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
Poland
Synta Pharmaceuticals Investigative Site
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
Romania
Synta Pharmaceuticals Investigative Site
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
Russian Federation
Synta Pharmaceuticals Investigative Site
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
Serbia
Synta Pharmaceuticals Investigative Site
Belgrade, Serbia, 11000
Synta Pharmaceuticals Investigative Site
Sremska Kamenica, Serbia, 21204
Spain
Synta Pharmaceuticals Investigative Site
Badalona, Spain, 08916
Synta Pharmaceuticals Investigative Site
Barcelona, Spain, 08035
Synta Pharmaceuticals Investigative Site
Madrid, Spain, 28040
United Kingdom
Synta Pharmaceuticals Investigational Site
Leicester, United Kingdom, LE2 7HL
Synta Pharmaceuticals Investigative Site
London, United Kingdom, SE1 9RT
Synta Pharmaceuticals Investigational Site
London, United Kingdom, SW3 6JJ
Synta Pharmaceuticals Investigational Site
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Synta Pharmaceuticals Corp.
  More Information

No publications provided

Responsible Party: Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier: NCT01348126     History of Changes
Other Study ID Numbers: 9090-08
Study First Received: May 2, 2011
Last Updated: May 13, 2013
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Bosnia: Federal Ministry of Health
Canada: Health Canada
Croatia: Ministry of Health and Social Care
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Synta Pharmaceuticals Corp.:
Advanced non-small cell lung cancer
NSCLC
Lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014