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

• ClinicalTrials.gov Identifier: NCT01798485
• Recruitment Status: Terminated
• First Posted: February 25, 2013
• Results First Posted: July 1, 2016
• Last Update Posted: July 1, 2016
• Sponsor: Synta Pharmaceuticals Corp.
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Ganetespib and Docetaxel	Docetaxel	Total
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
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

Outcome Measures

1. Primary Outcome

Title	Overall Survival as of 19 October 2015
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

Outcome Measure Data

Analysis Population Description

Randomized participants

Arm/Group Title	Ganetespib and Docetaxel	Docetaxel
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)

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]

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
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

Outcome Measure Data

Analysis Population Description

Randomized participants

Arm/Group Title	Ganetespib and Docetaxel	Docetaxel
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)

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
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

Outcome Measure Data

Analysis Population Description

Randomized participants with elevated LDH at screening

Arm/Group Title	Ganetespib and Docetaxel	Docetaxel
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)

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
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

Outcome Measure Data

Analysis Population Description

Randomized participants

Arm/Group Title	Ganetespib and Docetaxel	Docetaxel
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)

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
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

Outcome Measure Data

Analysis Population Description

Randomized participants

Arm/Group Title	Ganetespib and Docetaxel	Docetaxel
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)

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]

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
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

Outcome Measure Data

Analysis Population Description

Randomized participants who had a confirmed response

Arm/Group Title	Ganetespib and Docetaxel	Docetaxel
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)

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
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

Outcome Measure Data

Analysis Population Description

Randomized participants who had an elevated screening LDH

Arm/Group Title	Ganetespib and Docetaxel	Docetaxel
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)

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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

Analysis Population Description

Randomized participants

Arm/Group Title	Ganetespib and Docetaxel	Docetaxel
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)

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
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

Outcome Measure Data

Analysis Population Description

Randomized participants

Arm/Group Title	Ganetespib and Docetaxel	Docetaxel
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

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
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

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Ganetespib and Docetaxel	Docetaxel
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
Description	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

Outcome Measure Data

Analysis Population Description

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
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
Description	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

Outcome Measure Data

Analysis Population Description

Randomized participants

Arm/Group Title	Ganetespib and Docetaxel	Docetaxel
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
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

Outcome Measure Data

Analysis Population Description

Randomized

Arm/Group Title	Ganetespib and Docetaxel	Docetaxel
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.

Adverse Events

Time Frame	up to 36 months
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Docetaxel		Ganetespib and Docetaxel
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	--/--		--/--
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.
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)

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: President, Chief Executive Officer
• Organization: Synta Pharmaceuticals
• Phone: 781-541-7261

• Responsible Party: Synta Pharmaceuticals Corp.
• ClinicalTrials.gov Identifier: NCT01798485
• 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