Trial of Amrubicin as Treatment for Patients With HER2-Negative Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT01033032
First received: December 15, 2009
Last updated: December 22, 2014
Last verified: December 2014
Results First Received: November 21, 2014  
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: Amrubicin

  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
Patients were recruited at multiple dose levels into the Dose Escalation (Phase I) portion of this study to determine the safest dose of this regime (MTD - Maximum Tolerated Dose). Upon determination of this dose, patients being treated at the MTD proceeded to the Dose Expansion (Phase II) portion of the study and additional patients were recruited

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
Dose Level 1 Amrubicin - 90 mg/m^2 by intravenous (IV) every 21 days
Dose Level 2 Amrubicin - 100 mg/m^2 IV every 21 days
Dose Level 3 Amrubicin - 110 mg/m^2 IV every 21 days
Dose Level 4 Amrubicin - 120 mg/m^2 every 21 days

Participant Flow for 2 periods

Period 1:   Phase I
    Dose Level 1     Dose Level 2     Dose Level 3     Dose Level 4  
STARTED     3     3     3     6  
COMPLETED     0 [1]   0 [1]   3     0 [1]
NOT COMPLETED     3     3     0     6  
[1] Patients were on-study until determination of the Maximum Tolerated Dose (MTD)

Period 2:   Phase II
    Dose Level 1     Dose Level 2     Dose Level 3     Dose Level 4  
STARTED     0     0     66 [1]   0  
COMPLETED     0     0     0 [2]   0  
NOT COMPLETED     0     0     66     0  
[1] Includes patients treated at MTD during Phase I (3 patients); 63 additional patients enrolled
[2] Patients continued recieving treatment until disease progression or unacceptable toxicity



  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.
Includes Phase I and Phase II patients

Reporting Groups
  Description
All Patients Includes all Phase I and Phase II patients treated at all dose levels (total enrollment = 78 patients)

Baseline Measures
    All Patients  
Number of Participants  
[units: participants]
  78  
Age  
[units: Years]
Median (Full Range)
  58   (27 to 86)  
Gender  
[units: participants]
 
Female     78  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     78  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: every 6 weeks until progressive disease ]

2.  Secondary:   Number of Patients With Adverse Events as a Measure of Safety and Tolerability   [ Time Frame: every 6 weeks until treatment discontinuation, expected average 18 months ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: every 6 weeks until treatment discontinuation, expected average of 18 months ]

4.  Secondary:   Overall Response Rate (ORR)   [ Time Frame: every 6 weeks until treatment discontinuation, expected average 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 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: John D. Hainsworth, MD
Organization: Sarah Cannon Research Institute
phone: 1-877-691-7274
e-mail: asksarah@scresearch.net


No publications provided


Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT01033032     History of Changes
Other Study ID Numbers: SCRI BRE 161
Study First Received: December 15, 2009
Results First Received: November 21, 2014
Last Updated: December 22, 2014
Health Authority: United States: Food and Drug Administration