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

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ClinicalTrials.gov Identifier: NCT01798485
Recruitment Status : Terminated (The study was stopped after the first Interim Analysis due to futility.)
First Posted : February 25, 2013
Results First Posted : July 1, 2016
Last Update Posted : July 1, 2016
Sponsor:
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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
Enrollment 696
Recruitment Details 209 sites screened at least one patient and 175 sites randomized at least one patient.
Pre-assignment Details

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)
Arm/Group Title Ganetespib and Docetaxel Docetaxel
Hide Arm/Group Description 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 (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
Period Title: Overall Study
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
Reason Not Completed
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
Arm/Group Title Ganetespib and Docetaxel Docetaxel Total
Hide Arm/Group Description 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 (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion. Total of all reporting groups
Overall Number of Baseline Participants 347 349 696
Hide Baseline Analysis Population Description
All randomized participants as of 23 December 2015
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 347 participants 349 participants 696 participants
60.9  (8.93) 60.1  (8.69) 60.5  (8.81)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 347 participants 349 participants 696 participants
<65 years 227 247 474
>=65 years 120 102 222
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 347 participants 349 participants 696 participants
Female
141
  40.6%
135
  38.7%
276
  39.7%
Male
206
  59.4%
214
  61.3%
420
  60.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 347 participants 349 participants 696 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   0.3%
1
   0.3%
2
   0.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   0.3%
6
   1.7%
7
   1.0%
White
341
  98.3%
340
  97.4%
681
  97.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
   1.2%
2
   0.6%
6
   0.9%
Geographic region  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 347 participants 349 participants 696 participants
North America 41 44 85
Western Europe 101 96 197
Rest of World 205 209 414
Smoking History  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 347 participants 349 participants 696 participants
Never Smoked 62 62 124
Ever Smoked 282 284 566
Unknown 3 3 6
Time from Advanced NCSLC Diagnosis to Consent   [1] 
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 347 participants 349 participants 696 participants
11.54  (5.995) 11.76  (7.740) 11.65  (6.920)
[1]
Measure Description: NCSLC = non-small-cell lung cancer
Stage at Initial Diagnosis   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 347 participants 349 participants 696 participants
I/II 22 19 41
IIIA 18 18 36
IIIB 52 52 104
IV 254 258 512
Unknown 1 2 3
[1]
Measure Description: 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).
ECOG at Study Entry   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 347 participants 349 participants 696 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
[1]
Measure Description: 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.
Lactate Dehydrogenase (LDH) at Study Entry  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 347 participants 349 participants 696 participants
Normal 246 247 493
Elevated 101 102 203
Brain Metastasis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 347 participants 349 participants 696 participants
Yes 65 55 120
No 282 294 576
Bone Metastasis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 347 participants 349 participants 696 participants
Yes 115 100 215
No 232 249 481
Intra-Thoracic Metastasis only  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 347 participants 349 participants 696 participants
Yes 95 120 215
No 252 229 481
1.Primary Outcome
Title Overall Survival as of 19 October 2015
Hide Description Overall survival (OS) was measured from the date of randomization to the date of death from any cause.
Time Frame up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants
Arm/Group Title Ganetespib and Docetaxel Docetaxel
Hide Arm/Group Description:
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 (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
Overall Number of Participants Analyzed 335 337
Median (95% Confidence Interval)
Unit of Measure: months
10.9
(9.0 to 12.3)
10.5
(8.6 to 12.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ganetespib and Docetaxel, Docetaxel
Comments Primary study hypothesis was tested at a 2-sided, 0.05 significance level using a stratified log-rank test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3293
Comments [Not Specified]
Method Log Rank
Comments P-value was from stratified log-rank test (strata: screening LDH, screening ECOG and geographic region).
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.111
Confidence Interval (2-Sided) 95%
0.899 to 1.372
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ganetespib and Docetaxel, Docetaxel
Comments

Futility analysis for the first Interim Analysis which had a database cutoff of 19 October 2015. For the first interim analysis, if the lower limit of the 2-sided 99.5% confidence interval (CI) for the Hazard Ratio was greater than 0.75, then the study could be stopped for futility, based on Data Monitoring Committee recommendation.

Hazard ratio and 99.5% CI were calculated using the stratified Cox Proportional Hazards model (strata: screening LDH, screening ECOG and geographic region).

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.111
Confidence Interval (2-Sided) 99.5%
0.821 to 1.503
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Progression-free Survival (PFS) as of 19 October 2015
Hide Description

The progression–free interval is the interval from the date of randomization until tumor progression per modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1), clinical progression, or death from any cause in the absence of progressive disease, whichever occurs first. Data represents the investigator's assessment.

Progressive Disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Time Frame up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants
Arm/Group Title Ganetespib and Docetaxel Docetaxel
Hide Arm/Group Description:
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 (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
Overall Number of Participants Analyzed 335 337
Median (95% Confidence Interval)
Unit of Measure: months
4.2
(3.8 to 4.4)
4.3
(3.6 to 5.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ganetespib and Docetaxel, Docetaxel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1180
Comments Significance level of 0.05.
Method Log Rank
Comments Stratified log-rank test with stratification variables, ECOG, screening total LDH levels, and geographic region, used to compare the treatment groups.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.161
Confidence Interval (2-Sided) 95%
0.961 to 1.403
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Overall Survival (OS) In Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015
Hide Description OS was measured from the date of randomization to the date of death from any cause. Elevated LDH includes values above the upper limit of normal.
Time Frame up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with elevated LDH at screening
Arm/Group Title Ganetespib and Docetaxel Docetaxel
Hide Arm/Group Description:
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 (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
Overall Number of Participants Analyzed 99 98
Median (95% Confidence Interval)
Unit of Measure: months
7.1
(5.4 to 11.0)
9.0
(6.2 to 10.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ganetespib and Docetaxel, Docetaxel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2506
Comments Significance level of 0.05.
Method Log Rank
Comments P-value was from stratified log-rank test (strata: screening ECOG and geographic region).
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.232
Confidence Interval (2-Sided) 95%
0.865 to 1.754
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Objective Response Rate (ORR) as of 19 October 2015
Hide Description

Percentage of participants whose best overall response, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), was either a complete response (CR) or a partial response (PR).

CR was defined as the disappearance (or normalization) of all target lesions. PR was defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters.

Time Frame up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants
Arm/Group Title Ganetespib and Docetaxel Docetaxel
Hide Arm/Group Description:
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 (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
Overall Number of Participants Analyzed 335 337
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
13.7
(10.2 to 17.9)
16.0
(12.3 to 20.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ganetespib and Docetaxel, Docetaxel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.448
Comments Significance level of 0.05.
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Disease Control Rate (DCR) as of 19 October 2015
Hide Description

Percentage of participants whose best overall response, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), was either a complete response (CR), a partial response (PR), or stable disease (SD).

CR was defined as the disappearance (or normalization) of all target lesions. PR was defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters.

SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of diameters while on study. For participants with a best response of SD, duration of SD must be for at least 6 weeks or 12 weeks.

Time Frame up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants
Arm/Group Title Ganetespib and Docetaxel Docetaxel
Hide Arm/Group Description:
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 (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
Overall Number of Participants Analyzed 335 337
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
>=6 weeks
64.9
(59.1 to 69.6)
60.8
(55.4 to 66.1)
>=12 weeks
46.0
(40.5 to 51.5)
46.9
(41.5 to 52.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ganetespib and Docetaxel, Docetaxel
Comments >= 6 weeks
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.339
Comments Significance level of 0.05.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ganetespib and Docetaxel, Docetaxel
Comments >= 12 weeks
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.817
Comments Significance level of 0.05.
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title Kaplan-Meier Estimate of Duration of Response (DOR) as of 19 October 2015
Hide Description

Only participants who achieved a confirmed response (complete response (CR) or partial response (PR)) were included in the DOR analysis.

CR was defined as the disappearance (or normalization) of all target lesions.

PR was defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters.

Time Frame up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who had a confirmed response
Arm/Group Title Ganetespib and Docetaxel Docetaxel
Hide Arm/Group Description:
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 (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
Overall Number of Participants Analyzed 46 54
Median (95% Confidence Interval)
Unit of Measure: months
5.8
(3.0 to 5.9)
5.8
(4.3 to 6.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ganetespib and Docetaxel, Docetaxel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0111
Comments Significance level of 0.05.
Method Log Rank
Comments P-value was from stratified log-rank test (strata: screening LDH, screening ECOG and geographic region).
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.344
Confidence Interval (2-Sided) 95%
1.207 to 4.551
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Progression Free Survival (PFS) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015
Hide Description

The progression-free interval is the interval from the date of randomization until tumor progression per modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1), clinical progression, or death from any cause in the absence of progressive disease, whichever occurs first. Data represents the investigator's assessment.

Progressive Disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Elevated LDH includes values above the upper limit of normal.

Time Frame up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who had an elevated screening LDH
Arm/Group Title Ganetespib and Docetaxel Docetaxel
Hide Arm/Group Description:
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 (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
Overall Number of Participants Analyzed 99 98
Median (95% Confidence Interval)
Unit of Measure: months
3.0
(2.4 to 4.0)
2.8
(2.2 to 4.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ganetespib and Docetaxel, Docetaxel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5191
Comments Significance level of 0.05.
Method Log Rank
Comments P-value was from stratified log-rank test (strata: screening ECOG and geographic region).
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.112
Confidence Interval (2-Sided) 95%
0.797 to 1.551
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Objective Response Rate (ORR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015
Hide Description

Percentage of participants whose best overall response, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), was either a complete response (CR) or a partial response (PR).

CR was defined as the disappearance (or normalization) of all target lesions.

PR was defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters.

Elevated LDH includes values above the upper limit of normal.

This study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis.

Time Frame up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who had an elevated screening LDH. However, this study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis.
Arm/Group Title Ganetespib and Docetaxel Docetaxel
Hide Arm/Group Description:
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 (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Disease Control Rate (DCR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015
Hide Description

Percentage of participants whose best overall response, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), was a complete response (CR), a partial response (PR), or stable disease (SD).

CR was defined as the disappearance (or normalization) of all target lesions.

PR was defined as <=30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters.

SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of diameters while on study. The duration of SD must be for at least 6 weeks or 12 weeks.

Elevated LDH includes values above the upper limit of normal.

This study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis.

Time Frame up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who had an elevated screening LDH. However, this study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis.
Arm/Group Title Ganetespib and Docetaxel Docetaxel
Hide Arm/Group Description:
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 (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Kaplan-Meier Estimate for Time to Emergence of New Metastatic Lesion (TNL) as of 19 October 2015
Hide Description TNL was defined as time from the randomization date to the first day of radiological progression that included new metastatic lesions. Participants with no new metastatic lesions were censored at the date of the most recent radiological assessment.
Time Frame up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants
Arm/Group Title Ganetespib and Docetaxel Docetaxel
Hide Arm/Group Description:
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 (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
Overall Number of Participants Analyzed 335 337
Median (95% Confidence Interval)
Unit of Measure: months
8.1
(6.5 to 9.7)
8.7
(7.2 to 11.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ganetespib and Docetaxel, Docetaxel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1343
Comments Significance level of 0.05.
Method Log Rank
Comments Stratified log-rank test (strata: screening LDH, screening ECOG and geographic region).
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.233
Confidence Interval (2-Sided) 95%
0.937 to 1.621
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Participants With Progressive Disease Due to Any New Metastatic Lesion as of 19 October 2015
Hide Description Progressive disease was due to either new metastatic lesions only or new metastatic lesions and target tumor growth.
Time Frame up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants
Arm/Group Title Ganetespib and Docetaxel Docetaxel
Hide Arm/Group Description:
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 (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
Overall Number of Participants Analyzed 335 337
Measure Type: Number
Unit of Measure: percentage of participants
34.9 30.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ganetespib and Docetaxel, Docetaxel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.250
Comments Significance level of 0.05.
Method Fisher Exact
Comments [Not Specified]
12.Secondary Outcome
Title Participants With Treatment-Emergent Adverse Events as of 23 December 2015
Hide Description

Treatment-emergent adverse events (AEs) were defined as AEs that occurred from the time of first dose through 30 days after the last dose of study medication. The Investigator graded the severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria:

Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death A Serious AE (SAE) is defined as any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event.

Time Frame up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Ganetespib and Docetaxel Docetaxel
Hide Arm/Group Description:
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 (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
Overall Number of Participants Analyzed 338 342
Measure Type: Number
Unit of Measure: participants
>=1 AE 317 307
>=1 AE with CTCAE grade of 3 or 4 222 184
>=1 SAE 139 107
>=1 AE leading to dose reduction 61 37
>=1 AE leading to delayed dose 125 55
>=1 AE leading to study drug discontinuation 31 36
>=1 SAE leading to study drug discontinuation 19 15
>=1 SAE leading to hospitalization 109 87
>=1 SAE with outcome of death 40 30
>=1 AE with first occurrence during Cycle 1-2 280 280
>=1 AE with first occurrence during Cycle 1-4 304 299
>=1 AE with first occurrence during Cycle 1-6 312 302
13.Secondary Outcome
Title Patient-Reported Quality of Life as Measured by the European Quality Of Life - Five Dimensions - Three Levels (EQ-5D-3L) Survey
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The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. An overall EQ-5D-3L index was calculated (see EuroQoL website, http://www.euroqol.org/eq-5d-products/eq-5d-3l.html), with an index of 1.0 representing full health and and “0” represents dead, with some health states being worse than dead (<”0”).

This study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis.

Time Frame Day 1 (pre-treatment), Day 63 (Cycle 3 Day 1), Day 105 (Cycle 5 Day 1) and end of trial
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Randomized participants. However, this study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis.
Arm/Group Title Ganetespib and Docetaxel Docetaxel
Hide Arm/Group Description:
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 (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Patient-Reported Symptom Improvement as Measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) Version 4 Test
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The FACT-L contains 4 general subscales and a Lung Cancer Subscale (LCS). General subscales include: Physical Well-Being (PWB), Social/ Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). The LCS assesses symptoms commonly reported by lung cancer patients (e.g., shortness of breath, weight loss, and tightness in the chest). The FACT-L total score ranges from 0 to 136, higher scores represent better QOL.

Data were not summarized due to the early termination of the study due to futility.

Time Frame Day 1 (pre-treatment), Day 63 (Cycle 3 Day 1), Day 105 (Cycle 5 Day 1) and end of trial
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Randomized participants
Arm/Group Title Ganetespib and Docetaxel Docetaxel
Hide Arm/Group Description:
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 (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Other Pre-specified Outcome
Title Exploratory Biomarker Analyses
Hide Description Exploratory biomarker analyses was to assess correlation between biomarkers and clinical outcome. However, this study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis.
Time Frame up to 36 months
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Randomized
Arm/Group Title Ganetespib and Docetaxel Docetaxel
Hide Arm/Group Description:
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 (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame up to 36 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Docetaxel Ganetespib and Docetaxel
Hide Arm/Group Description Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion. 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.
All-Cause Mortality
Docetaxel Ganetespib and Docetaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Docetaxel Ganetespib and Docetaxel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   107/342 (31.29%)      139/338 (41.12%)    
Blood and lymphatic system disorders     
Anaemia  1  3/342 (0.88%)  3 6/338 (1.78%)  6
Febrile neutropenia  1  11/342 (3.22%)  11 19/338 (5.62%)  20
Leukopenia  1  1/342 (0.29%)  1 2/338 (0.59%)  2
Neutropenia  1  10/342 (2.92%)  15 12/338 (3.55%)  14
Cardiac disorders     
Atrial fibrillation  1  1/342 (0.29%)  1 2/338 (0.59%)  2
Bradycardia  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Cardiac arrest  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Cardiac failure  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Cardiac tamponade  1  0/342 (0.00%)  0 1/338 (0.30%)  2
Cardiopulmonary failure  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Ischaemic cardiomyopathy  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Myocardial infarction  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Pericardial effusion  1  1/342 (0.29%)  1 3/338 (0.89%)  3
Pericarditis  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Tachycardia  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Ear and labyrinth disorders     
Vertigo  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Eye disorders     
Retinal detachment  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Colitis ischaemic  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Constipation  1  2/342 (0.58%)  2 1/338 (0.30%)  1
Diarrhoea  1  2/342 (0.58%)  2 15/338 (4.44%)  15
Dry mouth  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Gastric perforation  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Gastrointestinal disorder  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Haematemesis  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Ileus  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Ileus paralytic  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Intestinal perforation  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Large intestinal obstruction  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Mesenteric artery thrombosis  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Nausea  1  1/342 (0.29%)  1 1/338 (0.30%)  1
Oesophageal stenosis  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Stomatitis  1  1/342 (0.29%)  1 1/338 (0.30%)  1
Subileus  1  1/342 (0.29%)  2 0/338 (0.00%)  0
Upper gastrointestinal haemorrhage  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Vomiting  1  2/342 (0.58%)  2 2/338 (0.59%)  3
General disorders     
Asthenia  1  1/342 (0.29%)  1 7/338 (2.07%)  9
Chest pain  1  3/342 (0.88%)  3 0/338 (0.00%)  0
Death  1 [1]  4/342 (1.17%)  4 2/338 (0.59%)  2
Fatigue  1  2/342 (0.58%)  2 1/338 (0.30%)  1
General physical health deterioration  1  2/342 (0.58%)  2 5/338 (1.48%)  6
Multi-organ failure  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Non-cardiac chest pain  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Oedema peripheral  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Pain  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Pyrexia  1  0/342 (0.00%)  0 3/338 (0.89%)  3
Strangulated hernia  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Sudden cardiac death  1  3/342 (0.88%)  3 0/338 (0.00%)  0
Sudden death  1  0/342 (0.00%)  0 3/338 (0.89%)  3
Hepatobiliary disorders     
Hepatitis toxic  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Immune system disorders     
Drug hypersensitivity  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Immunodeficiency  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Infections and infestations     
Anal abscess  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Bacteraemia  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Bronchitis  1  4/342 (1.17%)  4 0/338 (0.00%)  0
Bronchopneumonia  1  1/342 (0.29%)  1 5/338 (1.48%)  5
Bronchopulmonary aspergillosis  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Cellulitis  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Device related infection  1  0/342 (0.00%)  0 2/338 (0.59%)  2
Device related sepsis  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Diverticulitis  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Empyema  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Erysipelas  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Escherichia bacteraemia  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Gastroenteritis  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Infection  1  1/342 (0.29%)  1 3/338 (0.89%)  3
Lower respiratory tract infection  1  1/342 (0.29%)  1 3/338 (0.89%)  3
Lung infection  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Neutropenic sepsis  1  1/342 (0.29%)  1 2/338 (0.59%)  2
Oesophageal candidiasis  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Oral candidiasis  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Perirectal abscess  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Peritonsillar abscess  1  1/342 (0.29%)  1 1/338 (0.30%)  1
Pneumonia  1  2/342 (0.58%)  2 12/338 (3.55%)  12
Pseudomembranous colitis  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Pulmonary tuberculosis  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Respiratory tract infection  1  2/342 (0.58%)  2 3/338 (0.89%)  3
Sepsis  1  1/342 (0.29%)  1 4/338 (1.18%)  4
Sinusitis  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Skin infection  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Subcutaneous abscess  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Urinary tract infection  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Urosepsis  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Injury, poisoning and procedural complications     
Ankle fracture  1  0/342 (0.00%)  0 2/338 (0.59%)  2
Concussion  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Hip fracture  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Infusion related reaction  1  2/342 (0.58%)  2 3/338 (0.89%)  4
Joint dislocation  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Investigations     
Electrocardiogram QT prolonged  1  0/342 (0.00%)  0 1/338 (0.30%)  1
White blood cell count decreased  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Hyponatraemia  1  0/342 (0.00%)  0 2/338 (0.59%)  2
Hypovolaemia  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Metabolism and nutrition disorders     
Dehydration  1  3/342 (0.88%)  3 2/338 (0.59%)  2
Hyperkalaemia  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Metabolic acidosis  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Back pain  1  1/342 (0.29%)  1 1/338 (0.30%)  1
Bone pain  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Musculoskeletal chest pain  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Pain in extremity  1  1/342 (0.29%)  2 0/338 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer pain  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Neoplasm progression  1  11/342 (3.22%)  11 16/338 (4.73%)  16
Nervous system disorders     
Aphasia  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Cerebrovascular accident  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Hypersomnia  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Ischaemic stroke  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Loss of consciousness  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Paraesthesia  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Peripheral sensorimotor neuropathy  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Seizure  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Somnolence  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Syncope  1  1/342 (0.29%)  1 4/338 (1.18%)  4
Psychiatric disorders     
Completed suicide  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Confusional state  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Depression  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Mental status changes  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Psychotic disorder  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Renal and urinary disorders     
Acute kidney injury  1  0/342 (0.00%)  0 2/338 (0.59%)  2
Haematuria  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Acute respiratory failure  1  1/342 (0.29%)  1 2/338 (0.59%)  2
Aspiration  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Atelectasis  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Chronic obstructive pulmonary disease  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Cough  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Dyspnoea  1  11/342 (3.22%)  12 9/338 (2.66%)  9
Haemoptysis  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Pleural effusion  1  4/342 (1.17%)  6 3/338 (0.89%)  3
Pneumothorax  1  1/342 (0.29%)  1 2/338 (0.59%)  2
Pulmonary embolism  1  5/342 (1.46%)  5 3/338 (0.89%)  3
Pulmonary fibrosis  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Respiratory distress  1  1/342 (0.29%)  1 1/338 (0.30%)  1
Respiratory failure  1  0/342 (0.00%)  0 2/338 (0.59%)  2
Pneumonitis  1  1/342 (0.29%)  1 1/338 (0.30%)  1
Skin and subcutaneous tissue disorders     
Palmar-plantar erythrodysaesthesia syndrome  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Surgical and medical procedures     
Cancer surgery  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Vascular disorders     
Deep vein thrombosis  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Embolism  1  0/342 (0.00%)  0 2/338 (0.59%)  2
Hypertension  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Hypotension  1  2/342 (0.58%)  2 2/338 (0.59%)  2
Jugular vein thrombosis  1  0/342 (0.00%)  0 1/338 (0.30%)  1
Superior vena cava syndrome  1  0/342 (0.00%)  0 2/338 (0.59%)  2
Thrombosis  1  2/342 (0.58%)  2 0/338 (0.00%)  0
Venous thrombosis limb  1  1/342 (0.29%)  1 0/338 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.0)
[1]
When an SAE of death is received, the site is queried to request additional information. If the site is not able to determine a specific adverse event, they report 'death' as the event.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Docetaxel Ganetespib and Docetaxel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   293/342 (85.67%)      308/338 (91.12%)    
Blood and lymphatic system disorders     
Anaemia  1  70/342 (20.47%)  144 59/338 (17.46%)  106
Leukopenia  1  18/342 (5.26%)  54 20/338 (5.92%)  39
Neutropenia  1  94/342 (27.49%)  255 109/338 (32.25%)  243
Gastrointestinal disorders     
Constipation  1  26/342 (7.60%)  31 35/338 (10.36%)  41
Diarrhoea  1  47/342 (13.74%)  64 149/338 (44.08%)  327
Nausea  1  68/342 (19.88%)  103 59/338 (17.46%)  86
Stomatitis  1  36/342 (10.53%)  52 32/338 (9.47%)  40
Vomiting  1  23/342 (6.73%)  27 36/338 (10.65%)  46
General disorders     
Asthenia  1  48/342 (14.04%)  109 51/338 (15.09%)  100
Chest pain  1  17/342 (4.97%)  20 19/338 (5.62%)  26
Fatigue  1  72/342 (21.05%)  123 79/338 (23.37%)  130
Oedema peripheral  1  29/342 (8.48%)  30 28/338 (8.28%)  39
Pyrexia  1  19/342 (5.56%)  30 26/338 (7.69%)  33
Injury, poisoning and procedural complications     
Infusion related reaction  1  11/342 (3.22%)  13 17/338 (5.03%)  32
Investigations     
Weight decreased  1  18/342 (5.26%)  22 38/338 (11.24%)  50
Metabolism and nutrition disorders     
Decreased appetite  1  35/342 (10.23%)  49 52/338 (15.38%)  66
Hyponatraemia  1  9/342 (2.63%)  20 26/338 (7.69%)  46
Musculoskeletal and connective tissue disorders     
Arthralgia  1  20/342 (5.85%)  35 17/338 (5.03%)  24
Back pain  1  14/342 (4.09%)  19 24/338 (7.10%)  28
Bone pain  1  17/342 (4.97%)  24 19/338 (5.62%)  26
Myalgia  1  28/342 (8.19%)  52 38/338 (11.24%)  64
Pain in extremity  1  15/342 (4.39%)  19 18/338 (5.33%)  23
Nervous system disorders     
Dizziness  1  21/342 (6.14%)  30 24/338 (7.10%)  41
Headache  1  17/342 (4.97%)  23 22/338 (6.51%)  30
Neuropathy peripheral  1  33/342 (9.65%)  52 41/338 (12.13%)  63
Peripheral sensory neuropathy  1  23/342 (6.73%)  29 15/338 (4.44%)  18
Psychiatric disorders     
Insomnia  1  8/342 (2.34%)  8 23/338 (6.80%)  23
Respiratory, thoracic and mediastinal disorders     
Cough  1  31/342 (9.06%)  36 34/338 (10.06%)  45
Dyspnoea  1  41/342 (11.99%)  56 55/338 (16.27%)  59
Skin and subcutaneous tissue disorders     
Alopecia  1  84/342 (24.56%)  98 76/338 (22.49%)  93
Rash  1  16/342 (4.68%)  20 19/338 (5.62%)  21
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.0)
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.
Sponsor has the right, 60 days before submission for publication, to review disclosures and require deletion of its confidential information, excluding the study results. Public disclosure shall be delayed for up to 60 additional days in order for the Sponsor to file a patent application, if needed. Single center publications will be postponed until after disclosure of pooled data (all sites), or, for a period of 18 months from study completion/termination at all participating sites.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: President, Chief Executive Officer
Organization: Synta Pharmaceuticals
Phone: 781-541-7261
Layout table for additonal information
Responsible Party: Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier: NCT01798485     History of Changes
Other Study ID Numbers: 9090-14
2012-004349-34 ( EudraCT Number )
First Submitted: February 4, 2013
First Posted: February 25, 2013
Results First Submitted: March 7, 2016
Results First Posted: July 1, 2016
Last Update Posted: July 1, 2016