We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of LY2523355 in Participants With Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01416389
First Posted: August 15, 2011
Last Update Posted: December 4, 2017
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.
Information provided by (Responsible Party):
Eli Lilly and Company
Results First Submitted: September 27, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Metastatic Breast Cancer
Interventions: Drug: LY2523355
Drug: ixabepilone
Drug: pegfilgrastim
Drug: filgrastim

  Participant Flow
  Hide Participant Flow

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
Participants completed the study if they had at least 1 dose of study drug in Cycle 2 (or later) and had at least 1 post-baseline radiological tumor assessment or if the participant had a progression of disease or death. Non-completers were those that were lost to follow-up or who withdrew their consent to trial participation.

Reporting Groups
  Description
LY2523355 + Pegfilgrastim or Filgrastim

LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day [mg/m^2/day]). One participant was mistakenly dosed with 6 mg/m^2/day in Cycle 1 and for 2 doses in Cycle 2. The dose was subsequently corrected and the participant is included in this analysis.

Pegfilgrastim or filgrastim administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. Dosage is determined by standard of care.

If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.

Ixabepilone

Ixabepilone administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles.

Dosage determined by calculating participant's body surface area (40 mg/m^2).

If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.


Participant Flow:   Overall Study
    LY2523355 + Pegfilgrastim or Filgrastim   Ixabepilone
STARTED   26   13 
Received at Least 1 Dose of Study Drug   26   13 
COMPLETED   23   13 
NOT COMPLETED   3   0 
Lost to Follow-up                1                0 
Started New Therapy                2                0 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
Participants who received at least 1 dose of study medication (LY2523355 or ixabepilone). One participant was mistakenly dosed with 6 mg/m^2/day in Cycle 1 and for 2 doses in Cycle 2. The dose was subsequently corrected and the participant is included in this analysis.

Reporting Groups
  Description
LY2523355 + Pegfilgrastim or Filgrastim

LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day [mg/m^2/day]).

Pegfilgrastim or filgrastim administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. Dosage is determined by standard of care.

If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.

Ixabepilone

Ixabepilone administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles.

Dosage determined by calculating participant's body surface area (40 mg/m^2).

If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.

Total Total of all reporting groups

Baseline Measures
   LY2523355 + Pegfilgrastim or Filgrastim   Ixabepilone   Total 
Overall Participants Analyzed 
[Units: Participants]
 26   13   39 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.3  (9.9)   57.8  (9.9)   60.8  (10) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      26 100.0%      13 100.0%      39 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      26 100.0%      13 100.0%      39 100.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      5  19.2%      4  30.8%      9  23.1% 
White      21  80.8%      9  69.2%      30  76.9% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   26   13   39 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Tumor Size (CTS) From Baseline to the End of Cycle 2   [ Time Frame: Baseline up to end of Cycle 2 (Day 42) ]

2.  Secondary:   Percentage of Participants Achieving an Overall Response (Overall Response Rate)   [ Time Frame: Baseline to measured progressive disease or date of death from any cause (up to 423 days) ]

3.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: Baseline to measured progressive disease or date of death from any cause (up to 423 days) ]

4.  Secondary:   Percentage of Participants Achieving a Clinical Benefit (Clinical Benefit Rate)   [ Time Frame: Baseline to measured progressive disease or date of death from any cause (up to 423 days) ]

5.  Secondary:   Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LY2523355   [ Time Frame: Cycle 1: Day 1 and Day 3 ]

6.  Secondary:   Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LSN2546307   [ Time Frame: Cycle 1: Day 1 and Day 3 ]

7.  Secondary:   Pharmacokinetics, Intracycle Accumulation Ration (Ra) of LY2523355   [ Time Frame: Cycle 1: Day 1 and Day 3 ]

8.  Other Pre-specified:   Percentage of Deaths on Study Through the Follow-up Period   [ Time Frame: Baseline through end of treatment follow-up (up to 423 days) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979



Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01416389     History of Changes
Other Study ID Numbers: 12847
I1Y-MC-JFBE ( Other Identifier: Eli Lilly and Company )
First Submitted: August 11, 2011
First Posted: August 15, 2011
Results First Submitted: September 27, 2017
Results First Posted: December 4, 2017
Last Update Posted: December 4, 2017