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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Synta Pharmaceuticals Corp.
Sponsor:
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:
NCT01798485
First received: February 4, 2013
Last updated: October 22, 2014
Last verified: October 2014

February 4, 2013
October 22, 2014
March 2013
March 2016   (final data collection date for primary outcome measure)
Overall survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: 19 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01798485 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Progression-free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Overall Response Rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Disease control rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Duration of treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: 19 months ] [ Designated as safety issue: No ]
  • Symptom improvement [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Symptom improvement will be evaluated based on patient responses to quality of life questionnaires.
  • Qualitative and quantitative toxicities [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    As measured by adverse event rates, physical examination and laboratory evaluations
  • Clinical efficacy in biomarker-defined subpopulations. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Evaluate clinical efficacy in biomarker-defined subpopulations by use of transcriptional and proteomic profiling,analysis of genetic aberrations DNA derived from the tumor tissue and plasma samples.
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 19 months ] [ Designated as safety issue: Yes ]
  • Exploratory biomarker analyses [ Time Frame: 19 months ] [ Designated as safety issue: No ]
    Exploratory biomarker analyses will examine potential predictive biomarkers for correlation with ganetespib activity and safety.
Not Provided
Not Provided
 
A Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced NSCLC
A Randomized, Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced Non-Small-Cell Lung Adenocarcinoma

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
    Single agent docetaxel 75 mg/m2
  • Drug: Arm B: Combination of ganetespib and docetaxel
    ganetespib 150 mg/m2 in combination with docetaxel 75 mg/m2
  • Active Comparator: Single agent docetaxel
    Intervention: Drug: Arm A: single agent docetaxel
  • Experimental: Combination of ganetespib and docetaxel
    Intervention: Drug: Arm B: Combination of ganetespib and docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
850
March 2016
March 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Synta Pharmaceuticals ClinicalTrials.gov Call Center 855-499-9664 9090-14_StudyInfo@SyntaPharma.com
Czech Republic,   United States,   Austria,   Belgium,   Bosnia and Herzegovina,   United Kingdom,   Canada,   Croatia,   France,   Germany,   Hungary,   Netherlands,   Poland,   Romania,   Russian Federation,   Serbia,   Slovenia,   Spain,   Ukraine
 
NCT01798485
9090-14
Yes
Synta Pharmaceuticals Corp.
Synta Pharmaceuticals Corp.
Not Provided
Not Provided
Synta Pharmaceuticals Corp.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP