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A Study of Trabectedin or Dacarbazine for the Treatment of Patients With Advanced Liposarcoma or Leiomyosarcoma

This study has been completed.
Sponsor:
Collaborator:
PharmaMar
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01343277
First received: April 26, 2011
Last updated: July 15, 2016
Last verified: July 2016
Results First Received: December 22, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Advanced Liposarcoma or Leiomyosarcoma
Interventions: Drug: Trabectedin
Drug: Dacarbazine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Total enrolled participants were 577, but 2 participants were randomized twice, therefore counted twice in enrollment. Thus, enrolled participants are reported as 579.

Reporting Groups
  Description
Trabectedin Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
Dacarbazine Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.

Participant Flow:   Overall Study
    Trabectedin     Dacarbazine  
STARTED     384     193  
Treated     378     172  
COMPLETED     0     0  
NOT COMPLETED     384     193  
Unspecified                 3                 3  
Withdrawal by Subject                 18                 13  
Physician Decision                 1                 2  
Death                 10                 1  
Adverse Event                 67                 13  
Disease progression                 270                 138  
Randomized not treated                 6                 21  
Treatment ongoing                 8                 2  
Subsequent anticancer therapy                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Trabectedin Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
Dacarbazine Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
Total Total of all reporting groups

Baseline Measures
    Trabectedin     Dacarbazine     Total  
Number of Participants  
[units: participants]
  384     193     577  
Age  
[units: years]
Mean (Standard Deviation)
  56.5  (11.04)     54.1  (11.92)     55.7  (11.39)  
Gender  
[units: participants]
     
Female     262     140     402  
Male     122     53     175  
Region of Enrollment  
[units: participants]
     
AUS     15     8     23  
BRA     10     2     12  
NZL     3     0     3  
USA     356     183     539  



  Outcome Measures
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1.  Primary:   Overall Survival (OS)   [ Time Frame: approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015] ]

2.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013]) ]

3.  Secondary:   Time to Progression   [ Time Frame: approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013]) ]

4.  Secondary:   Objective Response Rate   [ Time Frame: approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013]) ]

5.  Secondary:   Duration of Response   [ Time Frame: approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013]) ]

6.  Secondary:   Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015]) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Director
Organization: Janssen Research & Development, LLC
e-mail: ClinicalTrialDisclosure@its.jnj.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01343277     History of Changes
Other Study ID Numbers: CR018004
ET743SAR3007 ( Other Identifier: Janssen Research & Development, LLC )
Study First Received: April 26, 2011
Results First Received: December 22, 2015
Last Updated: July 15, 2016
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Health Research Council
Brazil: Ministry of Health