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Lonafarnib in Metastatic Breast Cancer

This study has been terminated.
(funding terminated)
Sponsor:
Collaborators:
Schering-Plough
Hoosier Cancer Research Network
Information provided by (Responsible Party):
George Sledge, Hoosier Cancer Research Network
ClinicalTrials.gov Identifier:
NCT00773474
First received: October 14, 2008
Last updated: January 21, 2016
Last verified: January 2016
Results First Received: December 15, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Metastatic Breast Cancer
Intervention: Drug: Lonafarnib

  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
Lonafarnib

All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.

Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator’s discretion.


Participant Flow:   Overall Study
    Lonafarnib
STARTED   29 
COMPLETED   29 
NOT COMPLETED   0 



  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
Lonafarnib

All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.

Lonafarnib: All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator’s discretion.


Baseline Measures
   Lonafarnib 
Overall Participants Analyzed 
[Units: Participants]
 29 
Age 
[Units: Years]
Median (Full Range)
 56 
 (41 to 76) 
Gender 
[Units: Participants]
 
Female   29 
Male   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   1 
Not Hispanic or Latino   27 
Unknown or Not Reported   1 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   3 
White   26 
More than one race   0 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   29 
Primary Tumor Diagnosis [1] 
[Units: Participants]
 
Breast Carcinoma   14 
Ductal Breast Carcinoma   20 
Lobular Breast Carcinoma   1 
Other   1 
[1] Participants can have more than one primary tumor diagnosis. The sum of all tumor diagnoses can/will be greater than the number of participants.
Estrogen Receptor (ER)/Progesterone Receptor (PR)/ HER2 Status [1] 
[Units: Participants]
 
ER-   9 
ER+   15 
PR-   13 
PR+   11 
HER2-   17 
HER2+   3 
Unknown   4 
[1] Hormone Receptor Status. Each participant can have 0-3 possible HR statuses, consequently the sum of all HR statuses will be greater than the number of participants.
Number of Prior Therapies 
[Units: Prior Therapies]
Median (Full Range)
 8.4 
 (0 to 20) 


  Outcome Measures
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1.  Primary:   Progression Free Survival   [ Time Frame: 18 months ]

2.  Secondary:   Overall Response Rate   [ Time Frame: 18 months ]

3.  Secondary:   Toxicity Profile of Lonafarib   [ Time Frame: 18 months ]

4.  Secondary:   Clinical Benefit Response Rate (Complete Response (CR)+Partial Response(PR)+Stable Disease(SD) > 180 Day Duration).   [ Time Frame: 18 months ]


  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: Principal Investigator
Organization: Hoosier Cancer Research Network, Inc.
phone: 317-921-2050
e-mail: jsmith@hoosiercancer.org



Responsible Party: George Sledge, Hoosier Cancer Research Network
ClinicalTrials.gov Identifier: NCT00773474     History of Changes
Other Study ID Numbers: HOG BRE07-126
Study First Received: October 14, 2008
Results First Received: December 15, 2015
Last Updated: January 21, 2016
Health Authority: United States: Food and Drug Administration