Trial · NCT01343277
A Study of Trabectedin or Dacarbazine for the Treatment of Patients With Advanced Liposarcoma or Leiomyosarcoma
NCT01343277, Phase 3, Completed, Janssen Research & Development, LLC; results first posted 2016-01-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Trabectedin or Dacarbazine for the Treatment of Patients With Advanced Liposarcoma or Leiomyosarcoma. Trials, record NCT01343277. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01343277
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Trabectedin or Dacarbazine for the Treatment of Patients With Advanced Liposarcoma or Leiomyosarcoma
- NCT number
- NCT01343277
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 579 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Advanced Liposarcoma or Leiomyosarcoma
- Interventions
- Trabectedin, Dacarbazine
- First posted
- 2011-04-28
- Last updated
- 2016-08-26
- Results first posted
- 2016-01-28
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015] | The OS is defined as the time from the date of first dose of study drug to date of death from any cause. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant will be last known to be alive. |
| Secondary | Progression-Free Survival (PFS) | approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013]) | The Progression-Free Survival (PFS) was assessed as median number of months from baseline until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier. Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed. |
| Secondary | Time to Progression | approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013]) | Time interval in months between the date of randomization and the date of disease progression or death due to progression, whichever occurred first. Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed. |
| Secondary | Objective Response Rate | approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013]) | The objective response rate (ORR) is defined as the percentage of participants who achieved a Complete response (CR) or partial response (PR) as best responses. according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST). CR defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than 10 millimeter (mm). PR defined as at least 30 percent (%) decrease in sum of the diameters of the target lesions taking as reference the Baseline sum diameters. Confirmed responses are those that persist on repeat imaging study for at least 4 weeks after initial documentation of response. Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed. |
| Secondary | Duration of Response | approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013]) | Duration of response is defined as the time from the date of initial documentation of a response (CR or PR) to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death. Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed. |
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015]) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Progression-Free Survival (PFS) | approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013]) | Analysis population included all the randomized participants up to interim analysis cut-off date (16 September 2013). N (number of participants analyzed) signifies the participants evaluable for this measure. | Months | MEDIAN |
| SECONDARY | Time to Progression | approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013]) | Analysis population included all the randomized participants up to interim analysis cut-off date (16 September 2013). N (number of participants analyzed) signifies the participants evaluable for this measure. | Months | MEDIAN |
| SECONDARY | Objective Response Rate | approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013]) | Analysis population included all the randomized participants up to interim analysis cut-off date (16 September 2013). N (number of participants analyzed) signifies the participants evaluable for this measure. | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response | approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013]) | Analysis population included all the randomized participants up to interim analysis cut-off date (16 September 2013). N (number of participants analyzed) signifies the participants evaluable for this measure. | Months | MEDIAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015]) | Safety population included all the treated participants. | Participants | NUMBER |
| PRIMARY | Overall Survival (OS) | approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015] | Analysis population included all the randomized participants up to up to final analysis cut-off date (05 January 2015). | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) | Trabectedin | 4.21 | 95% Confidence Interval 2.99 to 4.83 | Months | |
| Progression-Free Survival (PFS) | Dacarbazine | 1.54 | 95% Confidence Interval 1.48 to 2.60 | Months | |
| Time to Progression | Trabectedin | 4.24 | 95% Confidence Interval 3.22 to 4.93 | Months | |
| Time to Progression | Dacarbazine | 1.54 | 95% Confidence Interval 1.48 to 2.60 | Months | |
| Objective Response Rate | Trabectedin | 9.9 | 95% Confidence Interval 6.9 to 13.5 | Percentage of Participants | |
| Objective Response Rate | Dacarbazine | 6.9 | 95% Confidence Interval 3.6 to 11.8 | Percentage of Participants | |
| Duration of Response | Trabectedin | 6.47 | 95% Confidence Interval 3.58 to 7.62 | Months | |
| Duration of Response | Dacarbazine | 4.17 | 95% Confidence Interval 2.14 to NA | Months | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Trabectedin | Serious Adverse Events (SAEs) | 155 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Dacarbazine | Serious Adverse Events (SAEs) | 52 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Trabectedin | 384 | |
| Overall Study | STARTED | Dacarbazine | 193 | |
| Overall Study | Treated | Trabectedin | 378 | |
| Overall Study | Treated | Dacarbazine | 172 | |
| Overall Study | COMPLETED | Trabectedin | 0 | |
| Overall Study | COMPLETED | Dacarbazine | 0 | |
| Overall Study | NOT COMPLETED | Trabectedin | 384 | |
| Overall Study | NOT COMPLETED | Dacarbazine | 193 |
Source ClinicalTrials.gov
Adverse events510
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 | Trabectedin | 149 | 378 | |
| other | Anaemia | Blood and lymphatic system disorders | Dacarbazine | 48 | 172 | |
| other | Leukopenia | Blood and lymphatic system disorders | Trabectedin | 43 | 378 | |
| other | Leukopenia | Blood and lymphatic system disorders | Dacarbazine | 11 | 172 | |
| other | Neutropenia | Blood and lymphatic system disorders | Trabectedin | 111 | 378 | |
| other | Neutropenia | Blood and lymphatic system disorders | Dacarbazine | 31 | 172 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Trabectedin | 70 | 378 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Dacarbazine | 33 | 172 | |
| other | Abdominal Distension | Gastrointestinal disorders | Trabectedin | 30 | 378 | |
| other | Abdominal Distension | Gastrointestinal disorders | Dacarbazine | 16 | 172 |
1 to 10 of 510Source ClinicalTrials.gov
See all 510 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Trabectedin | ||
| Total, all-cause mortality | Dacarbazine | ||
| Total, other adverse events | Trabectedin | 375 | 378 |
| Total, other adverse events | Dacarbazine | 166 | 172 |
| Total, serious adverse events | Trabectedin | 155 | 378 |
| Total, serious adverse events | Dacarbazine | 52 | 172 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|
| Trabectedin vs Dacarbazine: 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.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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/NCT01343277
GET https://conductscience.org/api/trials/v1/NCT01343277/events?page=2