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A Study of Ixabepilone as Second-line Therapy for Locally Advanced, Recurrent, or Metastatic Endometrial Cancer (IXAMPLE2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00883116
First received: April 16, 2009
Last updated: February 12, 2014
Last verified: February 2014
Results First Received: December 6, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Endometrial Cancer
Interventions: Drug: Ixabepilone
Drug: Doxorubicin
Drug: Paclitaxel

  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
A total of 500 participants were enrolled, and 496 were randomized (248 to ixabepilone and 248 to control); 487 received treatment.

Reporting Groups
  Description
Ixabepilone, 40 mg/m^2, IV Participants received ixabepilone, 40 mg/m^2, given intravenously (IV) over 3 hours every 21 days until unacceptable toxicity or disease progression
Control Chemotherapy Participants received either paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.

Participant Flow:   Overall Study
    Ixabepilone, 40 mg/m^2, IV     Control Chemotherapy  
STARTED     248     239  
COMPLETED     39 [1]   29 [1]
NOT COMPLETED     209     210  
Adverse event unrelated to study drug                 5                 10  
Death                 6                 2  
Disease progression                 130                 127  
Lost to Follow-up                 0                 1  
Maximum clinical benefit                 13                 46  
Not identified                 3                 0  
Study drug toxicity                 36                 16  
Withdrawal by Subject                 14                 7  
No longer meets study criteria                 2                 1  
[1] Still receiving treatment



  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.
Baseline analyses are for randomized participants.

Reporting Groups
  Description
Ixabepilone, 40 mg/m^2, IV Participants received ixabepilone, 40 mg/m^2, given intravenously (IV) over 3 hours every 21 days until unacceptable toxicity or disease progression
Control Chemotherapy Participants received either paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
Total Total of all reporting groups

Baseline Measures
    Ixabepilone, 40 mg/m^2, IV     Control Chemotherapy     Total  
Number of Participants  
[units: participants]
  248     248     496  
Age  
[units: Years]
Median ( Full Range )
  64.0  
  ( 39.0 to 86.0 )  
  64.0  
  ( 33.0 to 88.0 )  
  64.0  
  ( 33.0 to 88.0 )  
Age, Customized  
[units: Participants]
     
Younger than 65 years     126     139     265  
65 years and older     122     109     231  
Younger than 50 years     14     18     32  
50 years and older     234     230     464  
Gender  
[units: participants]
     
Female     248     248     496  
Male     0     0     0  
Race/Ethnicity, Customized  
[units: Participants]
     
White     215     213     428  
Black or African American     12     18     30  
Asian     6     5     11  
Other     12     12     24  
American Indian or Alaska Native     3     0     3  
Karnofsky Performance Scale Index Status [1]
[units: Units on a scale]
     
100     86     86     172  
90     95     79     174  
80     48     64     112  
70     19     16     35  
<70     0     2     2  
Not reported     0     1     1  
[1] This scale classifies patients by functional impairment. The lower the Karnofsky score, the more impaired the patient is. 100=No complaints; 90=Normal activity; 80=Normal activity with effort; 70=Cares for self but unable to carry on normal activity or to do active work; 60=Requires occasional assistance, but is able to care for most of his personal needs; 50=Requires considerable assistance; 40=Disabled; requires special care; 30=Severely disabled hospitalization indicated; 20=Very sick; hospital admission necessary; 10=Fatal processes progressing rapidly; 0=Death.



  Outcome Measures
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1.  Primary:   Overall Survival (OS)   [ Time Frame: Date of randomization to date of death or last date censored to up to approximately 26 months ]

2.  Secondary:   Progression-free Survival   [ Time Frame: Date of randomization to date of disease progression or death (or date of last tumor assessment for those who did not die or progress) up to approximately 22 months ]

3.  Secondary:   Best Overall Response Rate   [ Time Frame: Date of randomization and every 6 weeks to end of treatment (9 cycles, or approximately Day 189) ]

4.  Secondary:   Number of Participants With a Serious Adverse Event (SAE), an SAE Related to Study Drug, Death as Outcome, a Peripheral Neuropathy Adverse Event (AE), a Grade 3 or Higher AE, and an AE Related to Study Drug   [ Time Frame: From Day 1, first dose to 30 days past last dose, up to Day 219 (9 cycles, or 189 days, + 30 days) ]


  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
This study was terminated per Data Monitoring Committee and protocol. Results from an interim analysis showed no favorable benefit/risk ratio for ixabepilone patients and that ixabepilone did not improve survival compared with control chemotherapies.


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


No publications provided


Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00883116     History of Changes
Other Study ID Numbers: CA163-196, 2008-007167-16
Study First Received: April 16, 2009
Results First Received: December 6, 2013
Last Updated: February 12, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Brazil: National Health Surveillance Agency
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Greece: Ethics Committee
Hungary: National Institute of Pharmacy
Italy: Ministry of Health
Korea: Food and Drug Administration
Mexico: Federal Commission for Sanitary Risks Protection
Norway: Directorate of Health
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Poland: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Taiwan: National Bureau of Controlled Drugs
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration