Trial Outcomes & Findings for A Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced NSCLC (NCT NCT01798485)
NCT ID: NCT01798485
Last Updated: 2016-07-01
Results Overview
Overall survival (OS) was measured from the date of randomization to the date of death from any cause.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
696 participants
Primary outcome timeframe
up to 36 months
Results posted on
2016-07-01
Participant Flow
209 sites screened at least one patient and 175 sites randomized at least one patient.
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)
Participant milestones
| Measure |
Ganetespib and Docetaxel
Ganetespib (150 mg/m\^2) and docetaxel (75 mg/m\^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
|
Docetaxel
Docetaxel (75 mg/m\^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
|
|---|---|---|
|
Overall Study
STARTED
|
347
|
349
|
|
Overall Study
Safety Population as of 23 Dec 2015
|
338
|
342
|
|
Overall Study
Randomized as of 19 October 2015
|
335
|
337
|
|
Overall Study
COMPLETED
|
1
|
59
|
|
Overall Study
NOT COMPLETED
|
346
|
290
|
Reasons for withdrawal
| Measure |
Ganetespib and Docetaxel
Ganetespib (150 mg/m\^2) and docetaxel (75 mg/m\^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
|
Docetaxel
Docetaxel (75 mg/m\^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
|
|---|---|---|
|
Overall Study
Adverse Event
|
32
|
40
|
|
Overall Study
Withdrawal by Subject
|
27
|
31
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
|
Overall Study
Physician Decision
|
14
|
10
|
|
Overall Study
Objective Disease Progression
|
152
|
106
|
|
Overall Study
Death
|
25
|
22
|
|
Overall Study
Sponsor Decision
|
61
|
54
|
|
Overall Study
Clinical Progression
|
35
|
24
|
Baseline Characteristics
A Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced NSCLC
Baseline characteristics by cohort
| Measure |
Ganetespib and Docetaxel
n=347 Participants
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
n=349 Participants
Docetaxel (75 mg/m\^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
|
Total
n=696 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.9 years
STANDARD_DEVIATION 8.93 • n=5 Participants
|
60.1 years
STANDARD_DEVIATION 8.69 • n=7 Participants
|
60.5 years
STANDARD_DEVIATION 8.81 • n=5 Participants
|
|
Age, Customized
<65 years
|
227 participants
n=5 Participants
|
247 participants
n=7 Participants
|
474 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
120 participants
n=5 Participants
|
102 participants
n=7 Participants
|
222 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
141 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
276 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
206 Participants
n=5 Participants
|
214 Participants
n=7 Participants
|
420 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
341 Participants
n=5 Participants
|
340 Participants
n=7 Participants
|
681 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Geographic region
North America
|
41 participants
n=5 Participants
|
44 participants
n=7 Participants
|
85 participants
n=5 Participants
|
|
Geographic region
Western Europe
|
101 participants
n=5 Participants
|
96 participants
n=7 Participants
|
197 participants
n=5 Participants
|
|
Geographic region
Rest of World
|
205 participants
n=5 Participants
|
209 participants
n=7 Participants
|
414 participants
n=5 Participants
|
|
Smoking History
Never Smoked
|
62 participants
n=5 Participants
|
62 participants
n=7 Participants
|
124 participants
n=5 Participants
|
|
Smoking History
Ever Smoked
|
282 participants
n=5 Participants
|
284 participants
n=7 Participants
|
566 participants
n=5 Participants
|
|
Smoking History
Unknown
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Time from Advanced NCSLC Diagnosis to Consent
|
11.54 months
STANDARD_DEVIATION 5.995 • n=5 Participants
|
11.76 months
STANDARD_DEVIATION 7.740 • n=7 Participants
|
11.65 months
STANDARD_DEVIATION 6.920 • n=5 Participants
|
|
Stage at Initial Diagnosis
I/II
|
22 participants
n=5 Participants
|
19 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Stage at Initial Diagnosis
IIIA
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Stage at Initial Diagnosis
IIIB
|
52 participants
n=5 Participants
|
52 participants
n=7 Participants
|
104 participants
n=5 Participants
|
|
Stage at Initial Diagnosis
IV
|
254 participants
n=5 Participants
|
258 participants
n=7 Participants
|
512 participants
n=5 Participants
|
|
Stage at Initial Diagnosis
Unknown
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
ECOG at Study Entry
0 = Fully Active
|
124 participants
n=5 Participants
|
125 participants
n=7 Participants
|
249 participants
n=5 Participants
|
|
ECOG at Study Entry
1 = Restrictive but Ambulatory
|
223 participants
n=5 Participants
|
224 participants
n=7 Participants
|
447 participants
n=5 Participants
|
|
ECOG at Study Entry
2 = Ambulatory unable to Work
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
ECOG at Study Entry
3 = Limited Self-Care
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
ECOG at Study Entry
4 = Completely Disabled
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Lactate Dehydrogenase (LDH) at Study Entry
Normal
|
246 participants
n=5 Participants
|
247 participants
n=7 Participants
|
493 participants
n=5 Participants
|
|
Lactate Dehydrogenase (LDH) at Study Entry
Elevated
|
101 participants
n=5 Participants
|
102 participants
n=7 Participants
|
203 participants
n=5 Participants
|
|
Brain Metastasis
Yes
|
65 participants
n=5 Participants
|
55 participants
n=7 Participants
|
120 participants
n=5 Participants
|
|
Brain Metastasis
No
|
282 participants
n=5 Participants
|
294 participants
n=7 Participants
|
576 participants
n=5 Participants
|
|
Bone Metastasis
Yes
|
115 participants
n=5 Participants
|
100 participants
n=7 Participants
|
215 participants
n=5 Participants
|
|
Bone Metastasis
No
|
232 participants
n=5 Participants
|
249 participants
n=7 Participants
|
481 participants
n=5 Participants
|
|
Intra-Thoracic Metastasis only
Yes
|
95 participants
n=5 Participants
|
120 participants
n=7 Participants
|
215 participants
n=5 Participants
|
|
Intra-Thoracic Metastasis only
No
|
252 participants
n=5 Participants
|
229 participants
n=7 Participants
|
481 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 36 monthsPopulation: Randomized participants
Overall survival (OS) was measured from the date of randomization to the date of death from any cause.
Outcome measures
| Measure |
Ganetespib and Docetaxel
n=335 Participants
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
n=337 Participants
Docetaxel (75 mg/m\^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
|
|---|---|---|
|
Overall Survival as of 19 October 2015
|
10.9 months
Interval 9.0 to 12.3
|
10.5 months
Interval 8.6 to 12.2
|
SECONDARY outcome
Timeframe: up to 36 monthsPopulation: Randomized participants
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.
Outcome measures
| Measure |
Ganetespib and Docetaxel
n=335 Participants
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
n=337 Participants
Docetaxel (75 mg/m\^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
|
|---|---|---|
|
Progression-free Survival (PFS) as of 19 October 2015
|
4.2 months
Interval 3.8 to 4.4
|
4.3 months
Interval 3.6 to 5.6
|
SECONDARY outcome
Timeframe: up to 36 monthsPopulation: Randomized participants with elevated LDH at screening
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.
Outcome measures
| Measure |
Ganetespib and Docetaxel
n=99 Participants
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
n=98 Participants
Docetaxel (75 mg/m\^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
|
|---|---|---|
|
Overall Survival (OS) In Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015
|
7.1 months
Interval 5.4 to 11.0
|
9.0 months
Interval 6.2 to 10.3
|
SECONDARY outcome
Timeframe: up to 36 monthsPopulation: Randomized participants
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.
Outcome measures
| Measure |
Ganetespib and Docetaxel
n=335 Participants
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
n=337 Participants
Docetaxel (75 mg/m\^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
|
|---|---|---|
|
Objective Response Rate (ORR) as of 19 October 2015
|
13.7 percentage of participants
Interval 10.2 to 17.9
|
16.0 percentage of participants
Interval 12.3 to 20.4
|
SECONDARY outcome
Timeframe: up to 36 monthsPopulation: Randomized participants
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.
Outcome measures
| Measure |
Ganetespib and Docetaxel
n=335 Participants
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
n=337 Participants
Docetaxel (75 mg/m\^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
|
|---|---|---|
|
Disease Control Rate (DCR) as of 19 October 2015
>=6 weeks
|
64.9 percentage of participants
Interval 59.1 to 69.6
|
60.8 percentage of participants
Interval 55.4 to 66.1
|
|
Disease Control Rate (DCR) as of 19 October 2015
>=12 weeks
|
46.0 percentage of participants
Interval 40.5 to 51.5
|
46.9 percentage of participants
Interval 41.5 to 52.4
|
SECONDARY outcome
Timeframe: up to 36 monthsPopulation: Randomized participants who had a confirmed response
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.
Outcome measures
| Measure |
Ganetespib and Docetaxel
n=46 Participants
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
n=54 Participants
Docetaxel (75 mg/m\^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
|
|---|---|---|
|
Kaplan-Meier Estimate of Duration of Response (DOR) as of 19 October 2015
|
5.8 months
Interval 3.0 to 5.9
|
5.8 months
Interval 4.3 to 6.9
|
SECONDARY outcome
Timeframe: up to 36 monthsPopulation: Randomized participants who had an elevated screening LDH
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.
Outcome measures
| Measure |
Ganetespib and Docetaxel
n=99 Participants
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
n=98 Participants
Docetaxel (75 mg/m\^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
|
|---|---|---|
|
Progression Free Survival (PFS) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015
|
3.0 months
Interval 2.4 to 4.0
|
2.8 months
Interval 2.2 to 4.1
|
SECONDARY outcome
Timeframe: up to 36 monthsPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 36 monthsPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 36 monthsPopulation: Randomized participants
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.
Outcome measures
| Measure |
Ganetespib and Docetaxel
n=335 Participants
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
n=337 Participants
Docetaxel (75 mg/m\^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
|
|---|---|---|
|
Kaplan-Meier Estimate for Time to Emergence of New Metastatic Lesion (TNL) as of 19 October 2015
|
8.1 months
Interval 6.5 to 9.7
|
8.7 months
Interval 7.2 to 11.6
|
SECONDARY outcome
Timeframe: up to 36 monthsPopulation: Randomized participants
Progressive disease was due to either new metastatic lesions only or new metastatic lesions and target tumor growth.
Outcome measures
| Measure |
Ganetespib and Docetaxel
n=335 Participants
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
n=337 Participants
Docetaxel (75 mg/m\^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
|
|---|---|---|
|
Percentage of Participants With Progressive Disease Due to Any New Metastatic Lesion as of 19 October 2015
|
34.9 percentage of participants
|
30.6 percentage of participants
|
SECONDARY outcome
Timeframe: up to 36 monthsPopulation: Safety population
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.
Outcome measures
| Measure |
Ganetespib and Docetaxel
n=338 Participants
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
n=342 Participants
Docetaxel (75 mg/m\^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
|
|---|---|---|
|
Participants With Treatment-Emergent Adverse Events as of 23 December 2015
>=1 AE
|
317 participants
|
307 participants
|
|
Participants With Treatment-Emergent Adverse Events as of 23 December 2015
>=1 AE with CTCAE grade of 3 or 4
|
222 participants
|
184 participants
|
|
Participants With Treatment-Emergent Adverse Events as of 23 December 2015
>=1 SAE
|
139 participants
|
107 participants
|
|
Participants With Treatment-Emergent Adverse Events as of 23 December 2015
>=1 AE leading to dose reduction
|
61 participants
|
37 participants
|
|
Participants With Treatment-Emergent Adverse Events as of 23 December 2015
>=1 AE leading to delayed dose
|
125 participants
|
55 participants
|
|
Participants With Treatment-Emergent Adverse Events as of 23 December 2015
>=1 AE leading to study drug discontinuation
|
31 participants
|
36 participants
|
|
Participants With Treatment-Emergent Adverse Events as of 23 December 2015
>=1 SAE with outcome of death
|
40 participants
|
30 participants
|
|
Participants With Treatment-Emergent Adverse Events as of 23 December 2015
>=1 AE with first occurrence during Cycle 1-2
|
280 participants
|
280 participants
|
|
Participants With Treatment-Emergent Adverse Events as of 23 December 2015
>=1 AE with first occurrence during Cycle 1-4
|
304 participants
|
299 participants
|
|
Participants With Treatment-Emergent Adverse Events as of 23 December 2015
>=1 AE with first occurrence during Cycle 1-6
|
312 participants
|
302 participants
|
|
Participants With Treatment-Emergent Adverse Events as of 23 December 2015
>=1 SAE leading to study drug discontinuation
|
19 participants
|
15 participants
|
|
Participants With Treatment-Emergent Adverse Events as of 23 December 2015
>=1 SAE leading to hospitalization
|
109 participants
|
87 participants
|
SECONDARY outcome
Timeframe: Day 1 (pre-treatment), Day 63 (Cycle 3 Day 1), Day 105 (Cycle 5 Day 1) and end of trialPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 (pre-treatment), Day 63 (Cycle 3 Day 1), Day 105 (Cycle 5 Day 1) and end of trialPopulation: Randomized participants
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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 36 monthsPopulation: Randomized
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.
Outcome measures
Outcome data not reported
Adverse Events
Docetaxel
Serious events: 107 serious events
Other events: 293 other events
Deaths: 0 deaths
Ganetespib and Docetaxel
Serious events: 139 serious events
Other events: 308 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Docetaxel
n=342 participants at risk
Docetaxel (75 mg/m\^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
|
Ganetespib and Docetaxel
n=338 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.88%
3/342 • Number of events 3 • up to 36 months
|
1.8%
6/338 • Number of events 6 • up to 36 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.2%
11/342 • Number of events 11 • up to 36 months
|
5.6%
19/338 • Number of events 20 • up to 36 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.59%
2/338 • Number of events 2 • up to 36 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.9%
10/342 • Number of events 15 • up to 36 months
|
3.6%
12/338 • Number of events 14 • up to 36 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.59%
2/338 • Number of events 2 • up to 36 months
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 2 • up to 36 months
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Cardiac disorders
Pericardial effusion
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.89%
3/338 • Number of events 3 • up to 36 months
|
|
Cardiac disorders
Pericarditis
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Eye disorders
Retinal detachment
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Gastrointestinal disorders
Constipation
|
0.58%
2/342 • Number of events 2 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.58%
2/342 • Number of events 2 • up to 36 months
|
4.4%
15/338 • Number of events 15 • up to 36 months
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Gastrointestinal disorders
Ileus
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Gastrointestinal disorders
Mesenteric artery thrombosis
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Gastrointestinal disorders
Nausea
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Gastrointestinal disorders
Stomatitis
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Gastrointestinal disorders
Subileus
|
0.29%
1/342 • Number of events 2 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Gastrointestinal disorders
Vomiting
|
0.58%
2/342 • Number of events 2 • up to 36 months
|
0.59%
2/338 • Number of events 3 • up to 36 months
|
|
General disorders
Asthenia
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
2.1%
7/338 • Number of events 9 • up to 36 months
|
|
General disorders
Chest pain
|
0.88%
3/342 • Number of events 3 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
General disorders
Death
|
1.2%
4/342 • Number of events 4 • up to 36 months
|
0.59%
2/338 • Number of events 2 • up to 36 months
|
|
General disorders
Fatigue
|
0.58%
2/342 • Number of events 2 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
General disorders
General physical health deterioration
|
0.58%
2/342 • Number of events 2 • up to 36 months
|
1.5%
5/338 • Number of events 6 • up to 36 months
|
|
General disorders
Multi-organ failure
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
General disorders
Non-cardiac chest pain
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
General disorders
Oedema peripheral
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
General disorders
Pain
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
General disorders
Pyrexia
|
0.00%
0/342 • up to 36 months
|
0.89%
3/338 • Number of events 3 • up to 36 months
|
|
General disorders
Strangulated hernia
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
General disorders
Sudden cardiac death
|
0.88%
3/342 • Number of events 3 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
General disorders
Sudden death
|
0.00%
0/342 • up to 36 months
|
0.89%
3/338 • Number of events 3 • up to 36 months
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Immune system disorders
Drug hypersensitivity
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Immune system disorders
Immunodeficiency
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Infections and infestations
Anal abscess
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Infections and infestations
Bronchitis
|
1.2%
4/342 • Number of events 4 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Infections and infestations
Bronchopneumonia
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
1.5%
5/338 • Number of events 5 • up to 36 months
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Infections and infestations
Cellulitis
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Infections and infestations
Device related infection
|
0.00%
0/342 • up to 36 months
|
0.59%
2/338 • Number of events 2 • up to 36 months
|
|
Infections and infestations
Device related sepsis
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Infections and infestations
Empyema
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Infections and infestations
Erysipelas
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Infections and infestations
Escherichia bacteraemia
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Infections and infestations
Gastroenteritis
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Infections and infestations
Infection
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.89%
3/338 • Number of events 3 • up to 36 months
|
|
Infections and infestations
Lower respiratory tract infection
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.89%
3/338 • Number of events 3 • up to 36 months
|
|
Infections and infestations
Lung infection
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Infections and infestations
Neutropenic sepsis
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.59%
2/338 • Number of events 2 • up to 36 months
|
|
Infections and infestations
Oesophageal candidiasis
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Infections and infestations
Peritonsillar abscess
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Infections and infestations
Pneumonia
|
0.58%
2/342 • Number of events 2 • up to 36 months
|
3.6%
12/338 • Number of events 12 • up to 36 months
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Infections and infestations
Respiratory tract infection
|
0.58%
2/342 • Number of events 2 • up to 36 months
|
0.89%
3/338 • Number of events 3 • up to 36 months
|
|
Infections and infestations
Sepsis
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
1.2%
4/338 • Number of events 4 • up to 36 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Infections and infestations
Subcutaneous abscess
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Infections and infestations
Urosepsis
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/342 • up to 36 months
|
0.59%
2/338 • Number of events 2 • up to 36 months
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.58%
2/342 • Number of events 2 • up to 36 months
|
0.89%
3/338 • Number of events 4 • up to 36 months
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Investigations
White blood cell count decreased
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.88%
3/342 • Number of events 3 • up to 36 months
|
0.59%
2/338 • Number of events 2 • up to 36 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Investigations
Hyponatraemia
|
0.00%
0/342 • up to 36 months
|
0.59%
2/338 • Number of events 2 • up to 36 months
|
|
Investigations
Hypovolaemia
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.29%
1/342 • Number of events 2 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
3.2%
11/342 • Number of events 11 • up to 36 months
|
4.7%
16/338 • Number of events 16 • up to 36 months
|
|
Nervous system disorders
Aphasia
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Nervous system disorders
Paraesthesia
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Nervous system disorders
Seizure
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Nervous system disorders
Somnolence
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Nervous system disorders
Syncope
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
1.2%
4/338 • Number of events 4 • up to 36 months
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Psychiatric disorders
Depression
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Psychiatric disorders
Mental status changes
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/342 • up to 36 months
|
0.59%
2/338 • Number of events 2 • up to 36 months
|
|
Renal and urinary disorders
Haematuria
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.59%
2/338 • Number of events 2 • up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.2%
11/342 • Number of events 12 • up to 36 months
|
2.7%
9/338 • Number of events 9 • up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
4/342 • Number of events 6 • up to 36 months
|
0.89%
3/338 • Number of events 3 • up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.59%
2/338 • Number of events 2 • up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.5%
5/342 • Number of events 5 • up to 36 months
|
0.89%
3/338 • Number of events 3 • up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/342 • up to 36 months
|
0.59%
2/338 • Number of events 2 • up to 36 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Surgical and medical procedures
Cancer surgery
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Vascular disorders
Embolism
|
0.00%
0/342 • up to 36 months
|
0.59%
2/338 • Number of events 2 • up to 36 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Vascular disorders
Hypotension
|
0.58%
2/342 • Number of events 2 • up to 36 months
|
0.59%
2/338 • Number of events 2 • up to 36 months
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/342 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/342 • up to 36 months
|
0.59%
2/338 • Number of events 2 • up to 36 months
|
|
Vascular disorders
Thrombosis
|
0.58%
2/342 • Number of events 2 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Vascular disorders
Venous thrombosis limb
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.00%
0/338 • up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.29%
1/342 • Number of events 1 • up to 36 months
|
0.30%
1/338 • Number of events 1 • up to 36 months
|
Other adverse events
| Measure |
Docetaxel
n=342 participants at risk
Docetaxel (75 mg/m\^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
|
Ganetespib and Docetaxel
n=338 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.5%
70/342 • Number of events 144 • up to 36 months
|
17.5%
59/338 • Number of events 106 • up to 36 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.3%
18/342 • Number of events 54 • up to 36 months
|
5.9%
20/338 • Number of events 39 • up to 36 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
27.5%
94/342 • Number of events 255 • up to 36 months
|
32.2%
109/338 • Number of events 243 • up to 36 months
|
|
Gastrointestinal disorders
Constipation
|
7.6%
26/342 • Number of events 31 • up to 36 months
|
10.4%
35/338 • Number of events 41 • up to 36 months
|
|
Gastrointestinal disorders
Diarrhoea
|
13.7%
47/342 • Number of events 64 • up to 36 months
|
44.1%
149/338 • Number of events 327 • up to 36 months
|
|
Gastrointestinal disorders
Nausea
|
19.9%
68/342 • Number of events 103 • up to 36 months
|
17.5%
59/338 • Number of events 86 • up to 36 months
|
|
Gastrointestinal disorders
Stomatitis
|
10.5%
36/342 • Number of events 52 • up to 36 months
|
9.5%
32/338 • Number of events 40 • up to 36 months
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
23/342 • Number of events 27 • up to 36 months
|
10.7%
36/338 • Number of events 46 • up to 36 months
|
|
General disorders
Asthenia
|
14.0%
48/342 • Number of events 109 • up to 36 months
|
15.1%
51/338 • Number of events 100 • up to 36 months
|
|
General disorders
Chest pain
|
5.0%
17/342 • Number of events 20 • up to 36 months
|
5.6%
19/338 • Number of events 26 • up to 36 months
|
|
General disorders
Fatigue
|
21.1%
72/342 • Number of events 123 • up to 36 months
|
23.4%
79/338 • Number of events 130 • up to 36 months
|
|
General disorders
Oedema peripheral
|
8.5%
29/342 • Number of events 30 • up to 36 months
|
8.3%
28/338 • Number of events 39 • up to 36 months
|
|
General disorders
Pyrexia
|
5.6%
19/342 • Number of events 30 • up to 36 months
|
7.7%
26/338 • Number of events 33 • up to 36 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
3.2%
11/342 • Number of events 13 • up to 36 months
|
5.0%
17/338 • Number of events 32 • up to 36 months
|
|
Investigations
Weight decreased
|
5.3%
18/342 • Number of events 22 • up to 36 months
|
11.2%
38/338 • Number of events 50 • up to 36 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.2%
35/342 • Number of events 49 • up to 36 months
|
15.4%
52/338 • Number of events 66 • up to 36 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.6%
9/342 • Number of events 20 • up to 36 months
|
7.7%
26/338 • Number of events 46 • up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.8%
20/342 • Number of events 35 • up to 36 months
|
5.0%
17/338 • Number of events 24 • up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.1%
14/342 • Number of events 19 • up to 36 months
|
7.1%
24/338 • Number of events 28 • up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.0%
17/342 • Number of events 24 • up to 36 months
|
5.6%
19/338 • Number of events 26 • up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.2%
28/342 • Number of events 52 • up to 36 months
|
11.2%
38/338 • Number of events 64 • up to 36 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.4%
15/342 • Number of events 19 • up to 36 months
|
5.3%
18/338 • Number of events 23 • up to 36 months
|
|
Nervous system disorders
Dizziness
|
6.1%
21/342 • Number of events 30 • up to 36 months
|
7.1%
24/338 • Number of events 41 • up to 36 months
|
|
Nervous system disorders
Headache
|
5.0%
17/342 • Number of events 23 • up to 36 months
|
6.5%
22/338 • Number of events 30 • up to 36 months
|
|
Nervous system disorders
Neuropathy peripheral
|
9.6%
33/342 • Number of events 52 • up to 36 months
|
12.1%
41/338 • Number of events 63 • up to 36 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.7%
23/342 • Number of events 29 • up to 36 months
|
4.4%
15/338 • Number of events 18 • up to 36 months
|
|
Psychiatric disorders
Insomnia
|
2.3%
8/342 • Number of events 8 • up to 36 months
|
6.8%
23/338 • Number of events 23 • up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
31/342 • Number of events 36 • up to 36 months
|
10.1%
34/338 • Number of events 45 • up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.0%
41/342 • Number of events 56 • up to 36 months
|
16.3%
55/338 • Number of events 59 • up to 36 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
24.6%
84/342 • Number of events 98 • up to 36 months
|
22.5%
76/338 • Number of events 93 • up to 36 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.7%
16/342 • Number of events 20 • up to 36 months
|
5.6%
19/338 • Number of events 21 • up to 36 months
|
Additional Information
President, Chief Executive Officer
Synta Pharmaceuticals
Phone: 781-541-7261
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER