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Safety and Efficacy of SNX-5422 in Human Epidermal Growth Factor Receptor 2 (HER2) Positive Cancers

This study has been terminated.
(Business reasons)
Sponsor:
Information provided by (Responsible Party):
Esanex Inc.
ClinicalTrials.gov Identifier:
NCT01848756
First received: May 3, 2013
Last updated: September 29, 2016
Last verified: September 2016
Results First Received: April 1, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Cancer
Intervention: Drug: SNX-5422

  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
No text entered.

Reporting Groups
  Description
SNX-5422

Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.

SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle.


Participant Flow:   Overall Study
    SNX-5422
STARTED   15 
COMPLETED   12 [1] 
NOT COMPLETED   3 
Adverse Event                1 
Withdrawal by Subject                1 
Enrolled in Error                1 
[1] Cycle 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
SNX-5422

Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.

SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle.


Baseline Measures
   SNX-5422 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age 
[Units: Years]
Mean (Standard Deviation)
 58  (12.9) 
Gender 
[Units: Participants]
 
Female   9 
Male   6 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   1 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   0 
White   13 
More than one race   1 
Unknown or Not Reported   0 


  Outcome Measures
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1.  Primary:   Objective Response Rate   [ Time Frame: Up to 24 months from last patient entry ]

2.  Primary:   Progression Free Survival   [ Time Frame: Every 3 months until 24 months after the last subject has been enrolled ]

3.  Primary:   Overall Survival   [ Time Frame: Every 3 months until 24 months after the last subject has been enrolled ]

4.  Secondary:   Number of Patients With Adverse Events   [ Time Frame: Day 28 of each cycle ]

5.  Secondary:   Changes in Vital Signs, Physical Examination or Clinical Laboratory From Baseline   [ Time Frame: Day 28 of each cycle ]

6.  Secondary:   Ophthalmologic Changes From Baseline   [ Time Frame: Screening, end of Cycle 1, final visit ]

7.  Secondary:   Adverse Events by Severity and Relationship to Treatment   [ Time Frame: Every 28 day cycle ]


  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 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.
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: Eric Orlemans, Chief Scientific Officer
Organization: Esanex Inc
phone: 919-338-2019
e-mail: eorlemans@esanexpharma.com



Responsible Party: Esanex Inc.
ClinicalTrials.gov Identifier: NCT01848756     History of Changes
Other Study ID Numbers: SNX-5422-CLN1-008
Study First Received: May 3, 2013
Results First Received: April 1, 2016
Last Updated: September 29, 2016
Health Authority: United States: Food and Drug Administration