Trial · NCT01798485
A Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced NSCLC
NCT01798485, Phase 3, Terminated, Synta Pharmaceuticals Corp.; results first posted 2016-07-01
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced NSCLC. Trials, record NCT01798485. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01798485
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced NSCLC
- NCT number
- NCT01798485
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 696 participants, actual
- Lead sponsor
- Synta Pharmaceuticals Corp.
- 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
- Docetaxel, Ganetespib
- First posted
- 2013-02-25
- Last updated
- 2016-07-01
- Other registries' IDs
- eudract:2012-004349-34
- Results first posted
- 2016-07-01
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival as of 19 October 2015 | up to 36 months | Overall survival (OS) was measured from the date of randomization to the date of death from any cause. |
| Secondary | Progression-free Survival (PFS) as of 19 October 2015 | up to 36 months | 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. |
| Secondary | Overall Survival (OS) In Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015 | up to 36 months | 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. |
| Secondary | Objective Response Rate (ORR) as of 19 October 2015 | up to 36 months | 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. |
| Secondary | Disease Control Rate (DCR) as of 19 October 2015 | up to 36 months | 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. |
| Secondary | Kaplan-Meier Estimate of Duration of Response (DOR) as of 19 October 2015 | up to 36 months | 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. |
| Secondary | Progression Free Survival (PFS) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015 | up to 36 months | 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. |
| Secondary | Objective Response Rate (ORR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015 | up to 36 months | 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. |
| Secondary | Disease Control Rate (DCR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015 | up to 36 months | 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. |
| Secondary | Kaplan-Meier Estimate for Time to Emergence of New Metastatic Lesion (TNL) as of 19 October 2015 | up to 36 months | 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival as of 19 October 2015 | up to 36 months | Randomized participants | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) as of 19 October 2015 | up to 36 months | Randomized participants | months | MEDIAN |
| SECONDARY | Overall Survival (OS) In Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015 | up to 36 months | Randomized participants with elevated LDH at screening | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) as of 19 October 2015 | up to 36 months | Randomized participants | percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) as of 19 October 2015 | up to 36 months | Randomized participants | percentage of participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimate of Duration of Response (DOR) as of 19 October 2015 | up to 36 months | Randomized participants who had a confirmed response | months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015 | up to 36 months | Randomized participants who had an elevated screening LDH | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015 | up to 36 months | 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. | ||
| SECONDARY | Disease Control Rate (DCR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015 | up to 36 months | 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. | ||
| SECONDARY | Kaplan-Meier Estimate for Time to Emergence of New Metastatic Lesion (TNL) as of 19 October 2015 | up to 36 months | Randomized participants | months | MEDIAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival as of 19 October 2015 | Ganetespib and Docetaxel | 10.9 | 95% Confidence Interval 9.0 to 12.3 | months | |
| Overall Survival as of 19 October 2015 | Docetaxel | 10.5 | 95% Confidence Interval 8.6 to 12.2 | months | |
| Progression-free Survival (PFS) as of 19 October 2015 | Ganetespib and Docetaxel | 4.2 | 95% Confidence Interval 3.8 to 4.4 | months | |
| Progression-free Survival (PFS) as of 19 October 2015 | Docetaxel | 4.3 | 95% Confidence Interval 3.6 to 5.6 | months | |
| Overall Survival (OS) In Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015 | Ganetespib and Docetaxel | 7.1 | 95% Confidence Interval 5.4 to 11.0 | months | |
| Overall Survival (OS) In Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015 | Docetaxel | 9.0 | 95% Confidence Interval 6.2 to 10.3 | months | |
| Objective Response Rate (ORR) as of 19 October 2015 | Ganetespib and Docetaxel | 13.7 | 95% Confidence Interval 10.2 to 17.9 | percentage of participants | |
| Objective Response Rate (ORR) as of 19 October 2015 | Docetaxel | 16.0 | 95% Confidence Interval 12.3 to 20.4 | percentage of participants | |
| Disease Control Rate (DCR) as of 19 October 2015 | Ganetespib and Docetaxel | >=6 weeks | 64.9 | 95% Confidence Interval 59.1 to 69.6 | percentage of participants |
| Disease Control Rate (DCR) as of 19 October 2015 | Docetaxel | >=6 weeks | 60.8 | 95% Confidence Interval 55.4 to 66.1 | percentage of participants |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ganetespib and Docetaxel | 347 | |
| Overall Study | STARTED | Docetaxel | 349 | |
| Overall Study | Safety Population as of 23 Dec 2015 | Ganetespib and Docetaxel | 338 | |
| Overall Study | Safety Population as of 23 Dec 2015 | Docetaxel | 342 | |
| Overall Study | Randomized as of 19 October 2015 | Ganetespib and Docetaxel | 335 | |
| Overall Study | Randomized as of 19 October 2015 | Docetaxel | 337 | |
| Overall Study | COMPLETED | Ganetespib and Docetaxel | 1 | |
| Overall Study | COMPLETED | Docetaxel | 59 | |
| Overall Study | NOT COMPLETED | Ganetespib and Docetaxel | 346 | |
| Overall Study | NOT COMPLETED | Docetaxel | 290 |
Source ClinicalTrials.gov
Adverse events350
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Docetaxel | 70 | 342 | 144 |
| other | Anaemia | Blood and lymphatic system disorders | Ganetespib and Docetaxel | 59 | 338 | 106 |
| other | Leukopenia | Blood and lymphatic system disorders | Docetaxel | 18 | 342 | 54 |
| other | Leukopenia | Blood and lymphatic system disorders | Ganetespib and Docetaxel | 20 | 338 | 39 |
| other | Neutropenia | Blood and lymphatic system disorders | Docetaxel | 94 | 342 | 255 |
| other | Neutropenia | Blood and lymphatic system disorders | Ganetespib and Docetaxel | 109 | 338 | 243 |
| other | Constipation | Gastrointestinal disorders | Docetaxel | 26 | 342 | 31 |
| other | Constipation | Gastrointestinal disorders | Ganetespib and Docetaxel | 35 | 338 | 41 |
| other | Diarrhoea | Gastrointestinal disorders | Docetaxel | 47 | 342 | 64 |
| other | Diarrhoea | Gastrointestinal disorders | Ganetespib and Docetaxel | 149 | 338 | 327 |
1 to 10 of 350Source ClinicalTrials.gov
See all 350 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Docetaxel | ||
| Total, all-cause mortality | Ganetespib and Docetaxel | ||
| Total, other adverse events | Docetaxel | 293 | 342 |
| Total, other adverse events | Ganetespib and Docetaxel | 308 | 338 |
| Total, serious adverse events | Docetaxel | 107 | 342 |
| Total, serious adverse events | Ganetespib and Docetaxel | 139 | 338 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Docetaxel vs Ganetespib and Docetaxel: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01798485
GET https://conductscience.org/api/trials/v1/NCT01798485/results?page=2