Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Phase I/II Trial of Sorafenib Plus Ixabepilone in HER2-Negative Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
Bayer
Bristol-Myers Squibb
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00825734
First received: January 19, 2009
Last updated: December 16, 2014
Last verified: December 2014
Results First Received: November 21, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Metastatic Breast Cancer
Interventions: Drug: Sorafenib
Drug: Ixabepilone

  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 regimen (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 Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (40mg/m^2)
Dose Level -1 Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (32mg/m^2)
Dose Level 1a Sorafenib PO BID (400mg), Ixabepilone IV every 21 days (32mg/m^2)

Participant Flow for 2 periods

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

Period 2:   Phase II
    Dose Level 1     Dose Level -1     Dose Level 1a  
STARTED     0     0     76 [1]
COMPLETED     0     0     0  
NOT COMPLETED     0     0     76  
[1] Includes patients treated at MTD during Phase I and 73 additional patients enrolled for Phase II



  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
All Patients

Patients treated at all dose levels in the Phase I and Phase II portions of the study

: Dose Level 1 (4 patients) Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (40mg/m^2)

Dose Level -1 (3 patients) Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (32mg/m^2)

Dose Level 1a (76 patients) Sorafenib PO BID (400mg), Ixabepilone IV every 21 days (32mg/m^2)


Baseline Measures
    All Patients  
Number of Participants  
[units: participants]
  83  
Age  
[units: Years]
Median ( Full Range )
  57  
  ( 30 to 80 )  
Gender  
[units: participants]
 
Female     82  
Male     1  
Region of Enrollment  
[units: participants]
 
United States     83  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-Free Survival (PFS)   [ Time Frame: every 9 weeks until treatment discontinuation or death on study ]

2.  Secondary:   6-month Progression-Free Survival   [ Time Frame: every 9 weeks, up to 6 months ]

3.  Secondary:   Objective Response Rate   [ Time Frame: every 9 weeks until discontinuation of treatment ]

4.  Secondary:   Overall Survival (OS)   [ Time Frame: every 9 weeks until treatment discontinuation or death on study ]

5.  Secondary:   Number of Patients With Adverse Events as a Measure of of Safety and Tolerability   [ Time Frame: every 9 weeks until treatment discontinuation or unacceptable toxicity ]


  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: NCT00825734     History of Changes
Other Study ID Numbers: SCRI BRE 138
Study First Received: January 19, 2009
Results First Received: November 21, 2014
Last Updated: December 16, 2014
Health Authority: United States: Food and Drug Administration