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.
(The study was stopped after the first Interim Analysis due to futility.)
Sponsor:
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:
NCT01798485
First received: February 4, 2013
Last updated: May 26, 2016
Last verified: May 2016
Results First Received: March 7, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: 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
Interventions: Drug: Docetaxel
Drug: Ganetespib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
209 sites screened at least one patient and 175 sites randomized at least one patient.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

1220 patients with advanced NSCLC of adenocarcinoma histology diagnosed ≥6 months prior to study entry were screened. 696 patients were randomized in a 1:1 ratio to two arms and stratified by:

  • ECOG (0 versus 1)
  • Screening total LDH levels (normal vs. elevated)
  • Geographic region (North America and Western Europe vs. Rest of World)

Reporting Groups
  Description
Ganetespib and Docetaxel Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
Docetaxel Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.

Participant Flow:   Overall Study
    Ganetespib and Docetaxel     Docetaxel  
STARTED     347     349  
Safety Population as of 23 Dec 2015     338     342  
Randomized as of 19 October 2015     335     337  
COMPLETED     1     59  
NOT COMPLETED     346     290  
Adverse Event                 32                 40  
Withdrawal by Subject                 27                 31  
Lost to Follow-up                 0                 3  
Physician Decision                 14                 10  
Objective Disease Progression                 152                 106  
Death                 25                 22  
Sponsor Decision                 61                 54  
Clinical Progression                 35                 24  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants as of 23 December 2015

Reporting Groups
  Description
Ganetespib and Docetaxel Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
Docetaxel Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
Total Total of all reporting groups

Baseline Measures
    Ganetespib and Docetaxel     Docetaxel     Total  
Number of Participants  
[units: participants]
  347     349     696  
Age  
[units: years]
Mean (Standard Deviation)
  60.9  (8.93)     60.1  (8.69)     60.5  (8.81)  
Age, Customized  
[units: participants]
     
<65 years     227     247     474  
>=65 years     120     102     222  
Gender  
[units: participants]
     
Female     141     135     276  
Male     206     214     420  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     1     1     2  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     1     6     7  
White     341     340     681  
More than one race     0     0     0  
Unknown or Not Reported     4     2     6  
Geographic region  
[units: participants]
     
North America     41     44     85  
Western Europe     101     96     197  
Rest of World     205     209     414  
Smoking History  
[units: participants]
     
Never Smoked     62     62     124  
Ever Smoked     282     284     566  
Unknown     3     3     6  
Time from Advanced NCSLC Diagnosis to Consent [1]
[units: months]
Mean (Standard Deviation)
  11.54  (5.995)     11.76  (7.740)     11.65  (6.920)  
Stage at Initial Diagnosis [2]
[units: participants]
     
I/II     22     19     41  
IIIA     18     18     36  
IIIB     52     52     104  
IV     254     258     512  
Unknown     1     2     3  
ECOG at Study Entry [3]
[units: participants]
     
0 = Fully Active     124     125     249  
1 = Restrictive but Ambulatory     223     224     447  
2 = Ambulatory unable to Work     0     0     0  
3 = Limited Self-Care     0     0     0  
4 = Completely Disabled     0     0     0  
Lactate Dehydrogenase (LDH) at Study Entry  
[units: participants]
     
Normal     246     247     493  
Elevated     101     102     203  
Brain Metastasis  
[units: participants]
     
Yes     65     55     120  
No     282     294     576  
Bone Metastasis  
[units: participants]
     
Yes     115     100     215  
No     232     249     481  
Intra-Thoracic Metastasis only  
[units: participants]
     
Yes     95     120     215  
No     252     229     481  
[1] NCSLC = non-small-cell lung cancer
[2] Disease stage described using American Joint Committee on Cancer (AJCC). Stages ranged from I (cancer was small and had not spread to the lymph nodes) to IV (cancer spread throughout the body). Stage III (cancer had spread to nearby tissue or lymph nodes) was further differentiated based on regional lymph nodes: Stage IIIA (spread to nearby lymph nodes) and Stage IIIB (spread to distance lymph nodes).
[3] Eastern Cooperative Oncology Group (ECOG) Performance Status is used by doctors and researchers to assess how a participants' disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis.



  Outcome Measures
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1.  Primary:   Overall Survival as of 19 October 2015   [ Time Frame: up to 36 months ]

2.  Secondary:   Progression-free Survival (PFS) as of 19 October 2015   [ Time Frame: up to 36 months ]

3.  Secondary:   Overall Survival (OS) In Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015   [ Time Frame: up to 36 months ]

4.  Secondary:   Objective Response Rate (ORR) as of 19 October 2015   [ Time Frame: up to 36 months ]

5.  Secondary:   Disease Control Rate (DCR) as of 19 October 2015   [ Time Frame: up to 36 months ]

6.  Secondary:   Kaplan-Meier Estimate of Duration of Response (DOR) as of 19 October 2015   [ Time Frame: up to 36 months ]

7.  Secondary:   Progression Free Survival (PFS) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015   [ Time Frame: up to 36 months ]

8.  Secondary:   Objective Response Rate (ORR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015   [ Time Frame: up to 36 months ]

9.  Secondary:   Disease Control Rate (DCR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015   [ Time Frame: up to 36 months ]

10.  Secondary:   Kaplan-Meier Estimate for Time to Emergence of New Metastatic Lesion (TNL) as of 19 October 2015   [ Time Frame: up to 36 months ]

11.  Secondary:   Percentage of Participants With Progressive Disease Due to Any New Metastatic Lesion as of 19 October 2015   [ Time Frame: up to 36 months ]

12.  Secondary:   Participants With Treatment-Emergent Adverse Events as of 23 December 2015   [ Time Frame: up to 36 months ]

13.  Secondary:   Patient-Reported Quality of Life as Measured by the European Quality Of Life - Five Dimensions - Three Levels (EQ-5D-3L) Survey   [ Time Frame: Day 1 (pre-treatment), Day 63 (Cycle 3 Day 1), Day 105 (Cycle 5 Day 1) and end of trial ]

14.  Secondary:   Patient-Reported Symptom Improvement as Measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) Version 4 Test   [ Time Frame: Day 1 (pre-treatment), Day 63 (Cycle 3 Day 1), Day 105 (Cycle 5 Day 1) and end of trial ]

15.  Other Pre-specified:   Exploratory Biomarker Analyses   [ Time Frame: up to 36 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: President, Chief Executive Officer
Organization: Synta Pharmaceuticals
phone: 781-541-7261



Responsible Party: Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier: NCT01798485     History of Changes
Other Study ID Numbers: 9090-14
2012-004349-34 ( EudraCT Number )
Study First Received: February 4, 2013
Results First Received: March 7, 2016
Last Updated: May 26, 2016
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