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Inhalation SLIT Cisplatin (Liposomal) for the Treatment of Osteosarcoma Metastatic to the Lung

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00102531
First Posted: January 31, 2005
Last Update Posted: August 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Insmed Incorporated
Results First Submitted: July 5, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Osteosarcoma Metastatic
Intervention: Drug: Cisplatin liposomal

  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
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Reporting Groups
  Description
Cisplatin Liposomal 24 mg/m2

Inhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation for a maximum of 6 cycles.

Cisplatin liposomal

Cisplatin Liposomal 36 mg/m2

The study allowed for a dose escalation of liposomal cisplatin to 36 mg/m2 if no adverse events of Grade 3 or higher occurred after at least 3 cycles of drug administration at 24 mg/m2

Cisplatin liposomal


Participant Flow:   Overall Study
    Cisplatin Liposomal 24 mg/m2   Cisplatin Liposomal 36 mg/m2
STARTED   7   12 
COMPLETED   2   1 
NOT COMPLETED   5   11 
Adverse Event                0                1 
Disease Progression                5                9 
Physician Decision                0                1 



  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
Cisplatin Liposomal 24 mg/m2

Inhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation for a maximum of 6 cycles.

Cisplatin liposomal

Cisplatin Liposomal 36 mg/m2

The study allowed for a dose escalation of liposomal cisplatin to 36 mg/m2 if no adverse events of Grade 3 or higher occurred after at least 3 cycles of drug administration at 24 mg/m2

Cisplatin liposomal

Total Total of all reporting groups

Baseline Measures
   Cisplatin Liposomal 24 mg/m2   Cisplatin Liposomal 36 mg/m2   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   12   19 
Age 
[Units: Years]
Mean (Standard Deviation)
 19  (4.8)   17.8  (2.3)   18.2  (3.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  71.4%      2  16.7%      7  36.8% 
Male      2  28.6%      10  83.3%      12  63.2% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      1  14.3%      0   0.0%      1   5.3% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1  14.3%      1   8.3%      2  10.5% 
White      4  57.1%      9  75.0%      13  68.4% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1  14.3%      2  16.7%      3  15.8% 
Region of Enrollment 
[Units: Participants]
     
United States   7   12   19 


  Outcome Measures

1.  Primary:   The Study Medication Was to be Considered Effective if the Population Response Rate Was Found to be Greater Than 20% and Individuals Who Demonstrated a CR or PR or Whose Tumours Demonstrated a Grade 3 or 4 Histologic Response at the Time of Surgery.   [ Time Frame: 4 to 48 weeks ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Margaret Galluzzi
Organization: Insmed
phone: (908) 977-9900
e-mail: Margaret.Galluzzi@Insmed.com


Publications of Results:

Responsible Party: Insmed Incorporated
ClinicalTrials.gov Identifier: NCT00102531     History of Changes
Other Study ID Numbers: TR02-2421
First Submitted: January 29, 2005
First Posted: January 31, 2005
Results First Submitted: July 5, 2017
Results First Posted: August 1, 2017
Last Update Posted: August 1, 2017