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A Study to Assess the Potential Effects of a Single-Dose Administration of Trabectedin on the QT Intervals of the Electrocardiogram

This study has been completed.
Sponsor:
Collaborator:
PharmaMar
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00786838
First received: November 4, 2008
Last updated: March 13, 2014
Last verified: March 2014
Results First Received: March 29, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Solid Tumor
Interventions: Drug: Trabectedin
Drug: Placebo

  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
This study was conducted in 7 countries: Belgium (3 sites), France (2 sites), India (2 sites), Republic of Korea (4 sites), Russia (4 sites), Spain (1 site), and the United States (4 sites). Total 75 participants were enrolled in this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All enrolled participants (ie, 75 participants) received study medication. 26 participants completed the study.

Reporting Groups
  Description
Trabectedin 1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2

Participant Flow:   Overall Study
    Trabectedin  
STARTED     75  
COMPLETED     26  
NOT COMPLETED     49  
Physician Decision                 4  
Death                 4  
Adverse Event                 6  
Progressive disease                 31  
Withdrawal by Subject                 4  



  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 1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2

Baseline Measures
    Trabectedin  
Number of Participants  
[units: participants]
  75  
Age  
[units: years]
Mean ± Standard Deviation
  50.2  ± 11.04  
Gender  
[units: participants]
 
Female     51  
Male     24  
Race/Ethnicity, Customized  
[units: participants]
 
White     51  
Asian     23  
Other     1  
Region of Enrollment  
[units: participants]
 
Belgium     17  
France     3  
India     8  
Republic Of Korea     15  
Russia     17  
Spain     4  
United States Of America     11  



  Outcome Measures
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1.  Primary:   The Difference in the Change From Baseline (Predose on Day 1) in QTc Intervals Trabectedin Relative to Placebo at 24 Hour Post Dose by Fridericia Correction   [ Time Frame: Baseline (predose on Day 1) to 24 hour post dose (Day 1 or Day 2) ]

2.  Primary:   The Difference in the Change From Baseline (Predose on Day 1) in QTc Intervals Trabectedin Relative to Placebo at 24 Hour Post Dose by Bazett’s Correction   [ Time Frame: Baseline (predose on Day 1) to 24 hour post dose (Day 1 or Day 2) ]

3.  Secondary:   Maximum Plasma Concentration of Trabectedin (Cmax)   [ Time Frame: Baseline (predose on Day 2) to 24 hour post dose (Day 2 or Day 3). ]

4.  Secondary:   Time Taken to Acheive Maximum Plasma Concentration (Tmax)   [ Time Frame: Baseline (predose on Day 2) to 24 hour post dose (Day 2 or Day 3). ]

5.  Secondary:   Number of Participants With QTc Interval Increase From Baseline (Predose on Day 1) Greater Than 30 Milli Seconds   [ Time Frame: Baseline (predose) to approximately 24 hour post dose ]

6.  Secondary:   Number of Participants With QTc Interval Increase From Baseline (Predose on Day 1) Greater Than 60 Milli Seconds   [ Time Frame: Baseline (predose) to approximately 24 hour post dose ]

7.  Secondary:   Number of Participants With QTc Interval Greater Than 450 Milli Seconds   [ Time Frame: Baseline (predose) to approximately 24 hour post dose ]

8.  Secondary:   Number of Participants With QTc Interval Greater Than 480 Milli Seconds   [ Time Frame: Baseline (predose) to approximately 24 hour post dose ]

9.  Secondary:   Number of Participants With QTc Interval Greater Than 500 Milli Seconds   [ Time Frame: Baseline (predose) to approximately 24 hour post dose ]

10.  Secondary:   Number of Participants With PR Interval Greater Than 200 Milli Seconds   [ Time Frame: Baseline (predose) to approximately 24 hour post dose ]

11.  Secondary:   Number of Participants With QRS Interval Greater Than 120 Milli Seconds   [ Time Frame: Baseline (predose) to approximately 24 hour post dose ]

12.  Secondary:   Mean Heart Rate (Beats Per Minute) Over 24 Hours Postdose   [ Time Frame: Baseline (predose on Day 1) to 24 hour post dose ]


  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
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  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Senior Medical Director
Organization: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
phone: 1 908 704-5779


No publications provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications automatically indexed to this study:

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00786838     History of Changes
Other Study ID Numbers: CR014917, ET743OVC1001
Study First Received: November 4, 2008
Results First Received: March 29, 2013
Last Updated: March 13, 2014
Health Authority: United States: Food and Drug Administration