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Trivalent Ganglioside Vaccine With Immunological Adjuvant or Immunological Adjuvant Alone in Metastatic Sarcoma Patients Who Are Rendered Disease Free

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
MabVax Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01141491
First received: June 9, 2010
Last updated: October 14, 2016
Last verified: October 2016
Results First Received: October 14, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Sarcoma
Interventions: Biological: Trivalent ganglioside vaccine
Biological: OPT-821

  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
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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
Arm A- Vaccine Plus OPT-821 Trivalent ganglioside vaccine: Patients will be given 10 injections of ganglioside vaccine plus adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
Arm B - OPT-821 Immunologic Adjuvant Patients will be given 10 injections of OPT-821 alone as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84

Participant Flow:   Overall Study
    Arm A- Vaccine Plus OPT-821   Arm B - OPT-821 Immunologic Adjuvant
STARTED   68   68 
COMPLETED   20   21 
NOT COMPLETED   48   47 



  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.
Adults (male or female), 16 years of age and older who have metastatic sarcoma at initial presentation or who had relapsed disease and are rendered disease-free following surgical metastectomy

Reporting Groups
  Description
Arm A- Vaccine Plus OPT-821 Trivalent ganglioside vaccine: Patients will be given 10 injections of ganglioside vaccine plus adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
Arm B - OPT-821 Immunologic Adjuvant OPT-821: Patients will be given 10 injections of adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
Total Total of all reporting groups

Baseline Measures
   Arm A- Vaccine Plus OPT-821   Arm B - OPT-821 Immunologic Adjuvant   Total 
Overall Participants Analyzed 
[Units: Participants]
 68   68   136 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   57   51   108 
>=65 years   11   17   28 
Gender 
[Units: Participants]
     
Female   29   36   65 
Male   39   32   71 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   1   0   1 
Asian   4   3   7 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   1   3   4 
White   62   61   123 
More than one race   0   0   0 
Unknown or Not Reported   0   1   1 


  Outcome Measures

1.  Primary:   Progressions Free Survival   [ Time Frame: 3-years ]

2.  Secondary:   Overall Survival   [ Time Frame: Measured over time ]
Results not yet reported.   Anticipated Reporting Date:   04/2017   Safety Issue:   No


  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 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: Dave Hansen
Organization: MabVax Therapeutics, Inc.
phone: 858.259.9405 ext 301
e-mail: dhansen@mabvax.com



Responsible Party: MabVax Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01141491     History of Changes
Other Study ID Numbers: MV-0109DP001
Study First Received: June 9, 2010
Results First Received: October 14, 2016
Last Updated: October 14, 2016
Health Authority: United States: Food and Drug Administration