A Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced NSCLC (Galaxy 2)

This study has been terminated.
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:
First received: February 4, 2013
Last updated: November 3, 2015
Last verified: November 2015
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 patients with advanced non-small cell lung cancer.

Condition Intervention Phase
Non-Small-Cell Lung Adenocarcinoma
Non-small Cell Lung Cancer Stage IIIB
Non-small Cell Lung Cancer Stage IV
Non-small Cell Lung Cancer Metastatic
Drug: Arm A: single agent docetaxel
Drug: Arm B: Combination of ganetespib and docetaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced Non-Small-Cell Lung Adenocarcinoma

Resource links provided by NLM:

Further study details as provided by Synta Pharmaceuticals Corp.:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Objective Response Rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Disease control rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Symptom improvement [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Symptom improvement will be evaluated based on patient responses to quality of life questionnaires.

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Exploratory biomarker analyses [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Exploratory biomarker analyses will assess correlation between biomarkers and clinical outcome.

  • Emergence of metastatic lesions [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Enrollment: 696
Study Start Date: March 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Single agent docetaxel Drug: Arm A: single agent docetaxel
Single agent docetaxel 75 mg/m2
Experimental: Combination of ganetespib and docetaxel Drug: Arm B: Combination of ganetespib and docetaxel
ganetespib 150 mg/m2 in combination with docetaxel 75 mg/m2

Detailed Description:
Preliminary signals of clinical activity of ganetespib as a single agent have been observed in patients with advanced NSCLC. A Phase 2b/3 Study (9090-08) was initiated to evaluate the safety and activity of ganetespib in combination with docetaxel vs. docetaxel alone in NSCLC. Study 9090-08 is ongoing. Results from an interim analysis show that the combination has been well tolerated and an encouraging improvement in efficacy, including overall survival(OS) has been observed.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Advanced Stage IIIB or IV NSCLC
  • Eastern Oncology Cooperative Group (ECOG) Performance Status 0 or 1
  • Prior therapy defined as 1 prior systemic therapy for advanced disease
  • Documented disease progression during or following most first line therapy for advanced disease
  • Adequate hematologic, hepatic, renal function

Exclusion Criteria:

  • EGFR mutations
  • ALK translocations
  • Predominantly squamous, adenosquamous or unclear histologic type
  • 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01798485

  Show 268 Study Locations
Sponsors and Collaborators
Synta Pharmaceuticals Corp.
  More Information

Responsible Party: Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier: NCT01798485     History of Changes
Other Study ID Numbers: 9090-14 
Study First Received: February 4, 2013
Last Updated: November 3, 2015
Health Authority: United States: Food and Drug Administration
Austria: Austrian Agency for Health and Food Safety
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
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Italy: Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
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
Slovenia: Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators

ClinicalTrials.gov processed this record on May 22, 2016