Phase I Combination w/ Epirubicin

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00322374
First received: May 1, 2006
Last updated: April 21, 2011
Last verified: April 2011
Results First Received: July 6, 2010  
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: Ixabepilone
Drug: Epirubicin

  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
Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2 Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2 Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2 Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
All Participants No text entered.

Participant Flow for 4 periods

Period 1:   Enrollment
    Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2     Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2     Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2     All Participants  
STARTED     0     0     0     42  
COMPLETED     0     0     0     42  
NOT COMPLETED     0     0     0     0  

Period 2:   Starting Dose
    Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2     Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2     Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2     All Participants  
STARTED     6     0     0     0  
COMPLETED     0     0     0     0  
NOT COMPLETED     6     0     0     0  
Documented Disease Progression                 0                 0                 0                 0  
Physician Decision                 2                 0                 0                 0  
Study Drug Toxicity                 4                 0                 0                 0  
Participant Request                 0                 0                 0                 0  

Period 3:   First Escalation
    Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2     Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2     Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2     All Participants  
STARTED     0     30     0     0  
COMPLETED     0     0     0     0  
NOT COMPLETED     0     30     0     0  
Documented Disease Progression                 0                 6                 0                 0  
Physician Decision                 0                 12                 0                 0  
Study Drug Toxicity                 0                 11                 0                 0  
Participant Request                 0                 1                 0                 0  

Period 4:   Second Escalation
    Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2     Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2     Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2     All Participants  
STARTED     0     0     6     0  
COMPLETED     0     0     0     0  
NOT COMPLETED     0     0     6     0  
Physician Decision                 0                 0                 5                 0  
Study Drug Toxicity                 0                 0                 1                 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
Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2 Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2 Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2 Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
Total Total of all reporting groups

Baseline Measures
    Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2     Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2     Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2     Total  
Number of Participants  
[units: participants]
  6     30     6     42  
Age, Customized  
[units: participants]
       
Between 18 and 65 years     6     24     5     35  
>=65 years     0     6     1     7  
Age  
[units: years]
Median ( Full Range )
  57.5  
  ( 48 to 61 )  
  57.5  
  ( 38 to 69 )  
  53.5  
  ( 33 to 68 )  
  57  
  ( 33 to 69 )  
Gender  
[units: participants]
       
Female     6     30     6     42  
Male     0     0     0     0  
Region of Enrollment  
[units: participants]
       
France     5     16     3     24  
Italy     1     14     3     18  



  Outcome Measures
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1.  Primary:   Number of Participants With a Dose Limiting Toxicity (DLT)   [ Time Frame: From Baseline to the end of Cycle 1 (Day 21) ]

2.  Primary:   Ixabepilone Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (R2PD)   [ Time Frame: Day 21 of Cycle 1 ]

3.  Secondary:   Number of Participants With Death, Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3/4 AEs, or AEs Leading to Discontinuation   [ Time Frame: Evaluated continuously on study from Baseline to ≤30 days after the last dose of study drug. ]

4.  Secondary:   Maximum Plasma Concentration (Cmax) of Single-dose Ixabepilone   [ Time Frame: From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion. ]

5.  Secondary:   Area Under the Curve, Extrapolated to Infinity (AUC[INF]) of Single-dose Ixabepilone   [ Time Frame: From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion. ]

6.  Secondary:   Terminal Half-life (T-Half) of Single-dose Ixabepilone   [ Time Frame: From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion. ]

7.  Secondary:   Clearance (CLT) of Single-dose Ixabepilone   [ Time Frame: From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion. ]

8.  Secondary:   Volume of Distribution at Steady State (Vss) of Single-dose Ixabepilone   [ Time Frame: From the start of the ixabepilone infusion on Day 1 to 120 hours after the first infusion. ]

9.  Secondary:   Epirubicin Cmax   [ Time Frame: From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion. ]

10.  Secondary:   Epirubicin AUC(INF)   [ Time Frame: From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion. ]

11.  Secondary:   Epirubicin T-Half   [ Time Frame: From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion. ]

12.  Secondary:   Epirubicin CLT   [ Time Frame: From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion. ]

13.  Secondary:   Epirubicin Vss   [ Time Frame: From the start of the ixabepilone infusion on Day 1 to 24 hours after the first infusion. ]

14.  Secondary:   Number Of Participants With A Best Overall Tumor Response of Complete Response, Partial Response, Stable Disease, And Progressive Disease   [ Time Frame: From Baseline (up to 2 weeks prior to starting therapy) to the end Cycle 2 ]

15.  Secondary:   Duration of Tumor Response   [ Time Frame: Time (in months) when criteria for CR or PR are met (which ever occurs first) up to date of progressive disease. ]

16.  Secondary:   Number Of Participants With Tumor Response by Duration of Response Category   [ Time Frame: Time (in months) when criteria for CR or PR are met (which ever occurs first) up to date of progressive disease. ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


No publications provided


Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00322374     History of Changes
Other Study ID Numbers: CA163-104, Eudract No: 2005-004864-22
Study First Received: May 1, 2006
Results First Received: July 6, 2010
Last Updated: April 21, 2011
Health Authority: Italy:Commissario Straordinario dell' Istituto Nazionale per lo Studio e la Cura dei Tumori