Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00006317

Trial Description

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Title

A Randomized, Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced Non-Small-Cell Lung Adenocarcinoma

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Trial Acronym

Galaxy 2

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00006317
  •   2014/12/15
  •   2013/02/04
  •   no
  •   [---]*
  •   [---]*
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Secondary IDs

  •   2012-004349-34  
  •   NCT01798485  (ClinicalTrials.gov)
  •   9090-14  (Synta Pharmaceuticals Corp.)
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Health Condition or Problem studied

  •   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
  •   C34 -  Malignant neoplasm of bronchus and lung
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Interventions/Observational Groups

  •   Drug: Arm A: single agent docetaxel
  •   Drug: Arm B: Combination of ganetespib and docetaxel
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- Overall survival; time frame: 36 months

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Secondary Outcome

- Progression-free survival; time frame: 36 months
- Objective Response Rate; time frame: 36 months
- Disease control rate; time frame: 36 months
- Duration of response; time frame: 36 months
- Symptom improvement; time frame: 36 months; 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
- Exploratory biomarker analyses; time frame: 36 months; Exploratory biomarker analyses will assess correlation between biomarkers and clinical outcome.
- Emergence of metastatic lesions; time frame: 36 months

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Countries of Recruitment

  •   United States
  •   Austria
  •   Belgium
  •   Bosnia and Herzegovina
  •   Canada
  •   Croatia
  •   Czech Republic
  •   France
  •   Germany
  •   Hungary
  •   Netherlands
  •   Poland
  •   Romania
  •   Russian Federation
  •   Serbia
  •   Slovenia
  •   Spain
  •   Ukraine
  •   United Kingdom
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2013/03/31
  •   850
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Synta Pharmaceuticals Corp.
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    •   [---]*
    •   [---]*
    •   [---]*
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  • start of 1:1-Block address scientific-contact
    • Synta Pharmaceuticals ClinicalTrials.gov Call Center 
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    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Synta Pharmaceuticals ClinicalTrials.gov Call Center 
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   59
  •   2014/07/06
* This entry means the parameter is not applicable or has not been set.