A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion in Patients With Advanced Cancer.

This study has been completed.
Sponsor:
Collaborators:
Synteract, Inc.
Thywill Latam Solutions SRL
OCASA Soluciones Logísticas S.A.
Worldwide Clinical Trials Drug Development Solutions
Information provided by:
Mast Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00432562
First received: February 6, 2007
Last updated: January 19, 2012
Last verified: January 2012
Results First Received: January 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Breast Cancer
Non-small Cell Lung Cancer
Non-Hodgkins Lymphoma
Intervention: Drug: Vinorelbine Tartrate

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

STUDIED PERIOD:

First Patient Enrolled: 22 March 2007 Last Patient Completed: 02 November 2007 Study patients were enrolled at seven study sites in Argentina.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Pre-screening data was not collected for this study

Reporting Groups
  Description
ANX-530/Navelbine Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of ANX 530 in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of Navelbine in the second study period.
Navelbine/ANX-530 Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of Navelbine in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of ANX-530 in the second study period.

Participant Flow:   Overall Study
    ANX-530/Navelbine     Navelbine/ANX-530  
STARTED     16     15  
COMPLETED     13     15  
NOT COMPLETED     3     0  
Death                 3                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

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
ANX-530/Navelbine Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of ANX 530 in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of Navelbine in the second study period.
Navelbine/ANX-530 Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of Navelbine in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of ANX-530 in the second study period.
Total Total of all reporting groups

Baseline Measures
    ANX-530/Navelbine     Navelbine/ANX-530     Total  
Number of Participants  
[units: participants]
  16     15     31  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     11     10     21  
>=65 years     5     5     10  
Age  
[units: years]
Mean ± Standard Deviation
  62.2  ± 12.77     58.0  ± 13.34     60.2  ± 13.00  
Gender  
[units: participants]
     
Female     14     12     26  
Male     2     3     5  
Region of Enrollment  
[units: participants]
     
Argentina     16     15     31  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to Reach Maximum Observed Plasma Concentration (Tmax)   [ Time Frame: 0-144 hours post dose ]

2.  Primary:   Maximum Observed Plasma Concentration (Cmax)   [ Time Frame: 0-144 hours post-dose ]

3.  Primary:   Area Under the Plasma Concentratio-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast)   [ Time Frame: 0-144 hours post-dose ]

4.  Primary:   Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf)   [ Time Frame: 0-144 hours post-dose ]

5.  Primary:   Percentage of AUCinf Based on Extrapolation (AUCextrap)   [ Time Frame: 0-144 hours post-dose ]

6.  Primary:   Observed Elimination Rate Constant Associated With the Terminal Portion of the Curve (λ z)   [ Time Frame: 0-144 hours post-dose ]

7.  Primary:   Observed Terminal Elimination Half-Life (t1/2)   [ Time Frame: 0-144 hours post-dose ]

8.  Primary:   Time of Last Measurable Concentration (Tlast)   [ Time Frame: 0-144 hours post-dose ]

9.  Primary:   Last Quantifiable Drug Concentration (Clast)   [ Time Frame: 0-144 hours post-dose ]

10.  Primary:   Mean Residence Time (MRTinf)   [ Time Frame: 0-144 hours post-dose ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

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.


Limitations and Caveats
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.  


Results Point of Contact:  
Name/Title: Chief Executive Officer
Organization: Adventrx Pharmaceuticals
phone: 858-768-6325
e-mail: culley@adventrx.com


No publications provided


Responsible Party: Chief Executive Officer, Adventrx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00432562     History of Changes
Other Study ID Numbers: 530-01
Study First Received: February 6, 2007
Results First Received: January 19, 2012
Last Updated: January 19, 2012
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica