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Phase II Trial of Weekly or Every 3-week Ixabepilone for Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00593827
First Posted: January 15, 2008
Last Update Posted: March 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
US Oncology Research
Information provided by (Responsible Party):
R-Pharm
Results First Submitted: March 14, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Metastatic Breast Cancer
Intervention: 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
A total of 176 participants were enrolled by 55 sites in the United States over a period of 12 months.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All the 176 enrolled participants were randomized. Of the 5 participants who did not receive treatment, 2 were due to disease progression, 1 on participant request, and 2 due to other reasons.

Reporting Groups
  Description
Ixabepilone 16 mg/m^2 ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
Ixabepilone 40 mg/m^2 ixabepilone 40 mg/m^2 every 3 weeks

Participant Flow:   Overall Study
    Ixabepilone 16 mg/m^2   Ixabepilone 40 mg/m^2
STARTED   85 [1]   91 [2] 
Safety Population   82 [3]   89 [3] 
Evaluable Population   79 [4]   89 [4] 
COMPLETED   85 [5]   89 [6] 
NOT COMPLETED   0   2 
On Active Treatment/Pending                0                2 
[1] Intent-to-Treat (ITT) Population: Participants who were randomized (eligible and ineligible).
[2] ITT Population: Participants who were randomized (eligible and ineligible).
[3] Participants (eligible and ineligible) who received at least 1 dose of study drug.
[4] Treated participants with CR, PR, SD, PD, or NE response. Refer outcome measure 3 and 4 for details.
[5] Completed=off-study (Major reasons: Adverse events (AE)=15; disease progression=76; not treated=3).
[6] Completed=off-study (Major reasons: AEs=30; disease progression=55; not treated=2).



  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 16 mg/m^2 ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
Ixabepilone 40 mg/m^2 ixabepilone 40 mg/m^2 every 3 weeks
Total Total of all reporting groups

Baseline Measures
   Ixabepilone 16 mg/m^2   Ixabepilone 40 mg/m^2   Total 
Overall Participants Analyzed 
[Units: Participants]
 85   91   176 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.3  (11.4)   58.7  (10.4)   59.5  (10.9) 
Gender 
[Units: Participants]
     
Female   85   91   176 
Male   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian   69   70   139 
African American   9   10   19 
Hispanic   6   11   17 
Other   1   0   1 
Region of Enrollment 
[Units: Participants]
     
United States   85   91   176 
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) [1] 
[Units: Participants]
     
0=normal activity   39   43   82 
1=symptoms, but fully ambulatory   40   43   83 
2=symptomatic, but in bed < 50% of the day   6   5   11 
[1] The ECOG PS is used to assess disease severity. A score of 0 is normal activity; 1 is symptoms, but fully ambulatory; 2 is symptomatic, but in bed < 50% of the day; 3 is needs to be in bed > 50% of the day, but not bedridden; 4 is unable to get out of bed; 5 is dead.


  Outcome Measures
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1.  Primary:   Progression-Free Survival (PFS) at 6 Months (6-month PFS Rate): Proportion of Participants Progression Free at 6 Months   [ Time Frame: From the date of randomization to 6-months on study ]

2.  Secondary:   Median Progression Free Survival   [ Time Frame: From the date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 25.7 months) ]

3.  Secondary:   Overall Response Rate (ORR) Based on Response Criteria in Solid Tumors [RECIST]   [ Time Frame: Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months) ]

4.  Secondary:   Best Response as Assessed With RECIST   [ Time Frame: Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months) ]

5.  Secondary:   Overall Survival (OS)   [ Time Frame: From the date of randomization to date of death (maximum participant OS of 26.3 months) ]

6.  Secondary:   Time to Response   [ Time Frame: From the date of first dose to date of first PR or CR assessment ( maximum participant time to response of 8.3 months) ]

7.  Secondary:   Duration of Response   [ Time Frame: From the date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 17.4 months) ]

8.  Secondary:   Incidence of All Grades of Peripheral Neuropathy   [ Time Frame: Assessed from the date of first study dose until at least 30 days after the last dose of study drug. Median time on study therapy was 12 weeks (range: 4-60 weeks for 16 mg/m^2 arm; 3-87 weeks for 40 mg/m^2 arm). ]

9.  Other Pre-specified:   Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia   [ Time Frame: Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on study therapy was 12 weeks (range: 4-60 weeks for 16 mg/m^2 arm; 3-87 weeks for 40 mg/m^2 arm). ]


  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: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com



Responsible Party: R-Pharm
ClinicalTrials.gov Identifier: NCT00593827     History of Changes
Other Study ID Numbers: CA163-132
USOR 06-106
First Submitted: January 4, 2008
First Posted: January 15, 2008
Results First Submitted: March 14, 2012
Results First Posted: May 25, 2012
Last Update Posted: March 10, 2016