Back to resultsA Study of Ixabepilone as Second-line Therapy for Locally Advanced, Recurrent, or Metastatic Endometrial Cancer (IXAMPLE2)
Primary Purpose
Endometrial Cancer
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ixabepilone
Doxorubicin
Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Endometrial Cancer
Eligibility Criteria
Key Inclusion Criteria
- Women aged 18 years and older
- Histologic or cytologic diagnosis of endometrial carcinoma
- Evidence that the cancer is advanced, recurrent, or metastatic and not curable by local measures, such as surgery or radiation.
- Karnofsky performance status >=70
Measurable or nonmeasurable disease that has progressed since last treatment.
- If only disease is confined to a solitary lesion, its neoplastic nature must be confirmed by histology or cytology.
- Disease in a previously irradiated field is acceptable as the only site of measurable disease only if there has been clear progression since completion of radiotherapy.
- All therapy directed at endometrial cancer must be discontinued 21 days prior to start of treatment, except for hormonal therapy which must be discontinued at least 1 week prior to start of study treatment. Concurrent administration of hormone replacement therapy is allowed.
- Prior therapy: Participants must have failed 1 prior platinum-based chemotherapeutic regimen for endometrial cancer. May have received 2 prior chemotherapy regimens if 1 regimen was given for stage I or II disease. May have received any number of prior non-cytotoxic regimens such as monoclonal antibodies, cytokines, signal transduction inhibitors, or hormonal therapy. Previous radiation therapy is allowed.
Key Exclusion Criteria
- Carcinosarcoma (malignant mixed mullerian tumor)
- Endometrial leiomyosarcoma and endometrial stromal sarcomas
- Participants who received no prior chemotherapy for endometrial cancer or ≥2 prior chemotherapy regimens (exceptions defined in protocol)
- Known brain metastases
- Receipt of prior ixabepilone therapy
- Concurrent active infection requiring antibiotics or other therapy
- Concurrent unstable disease or other debilitating illness, such as congestive heart failure, unstable angina, myocardial infarction, or other cardiac disease that could jeopardize participation, within the last 6 months
- For participants whose prior therapy did not include an anthracycline and therefore may be randomized to doxorubicin, left ventricular ejection fraction <50% as measured by multigated radionuclide angiography or echocardiography
- History of malignancy, except nonmelanoma skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of the breast, within the last 5 years that has not been treated with chemotherapy
- Known human immunodeficiency viral infection
- Psychiatric disorders or other conditions rendering the participant incapable of complying with protocol requirements
- Absolute neutrophil count <1500/mm^3
- Platelets <100,000/mm^3
- Hemoglobin <9 g/dL
- Total bilirubin >1.5*upper limit of normal (ULN), except for those with Gilbert's disease
- Aspartate aminotransferase or alanine aminotransferase >2.5*ULN
- Serum creatinine >1.5*ULN
- Grade ≥2 neuropathy (sensory or motor)
- No concurrent therapy (chemotherapy, hormonal, or investigational) directed at endometrial cancer during the study
Sites / Locations
- University Of South Alabama
- Rocky Mountain Gynecologic Oncology
- Peter E. Schwartz, Md
- Hematology Oncology, P.C.
- Gynecologic Oncology Assoc.,Inc
- Florida Hospital Cancer Institute
- Sarasota Memorial Health Care System
- H. Lee Moffitt Cancer Center
- Georgia Health Science University
- Sudarshan K. Sharma, Md
- Central Dupage Hospital Cancer Center
- St. Vincent Hospital And Health Care Center, Inc.
- Hematology And Oncology Specialists, Llc
- Women'S Health Specialists
- Sparrow Regional Cancer Center
- University Of Minnesota
- Saint Dominic's Gynecologic Oncology
- Matthew A Powell, Md
- Blumenthal Cancer Center
- Duke University Medical Center
- Peggy And Charles Stephenson Oklahoma Cancer Center
- Tulsa Cancer Institute
- Pennsylvania Oncology Hematology Associates
- Magee-Womens Hospital Of Upmc Laboratory
- Women & Infants Hospital Of Ri
- Cancer Centers Of The Carolinas
- Tennessee Gynecologic Oncology Group, Llc
- University Of Virginia
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
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- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ixabepilone, 40 mg/m^2, intravenously (IV)
Control chemotherapy (Paclitaxel or Doxorubicin)
Arm Description
Participants received ixabepilone, 40 mg/m^2, given IV over 3 hours every 21 days until unacceptable toxicity or disease progression
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.
Outcomes
Primary Outcome Measures
Overall Survival (OS)
Survival was defined as the time from the date of randomization until the date of death. If the patient did not die, OS was censored on the last date he or she was known to be alive.
Secondary Outcome Measures
Progression-free Survival
Progression-free survival was defined as the time from randomization to the date of documented disease progression. Patients who died without a reported prior progression were considered to have progressed on the date of their death. Those who did not progress or die were censored on the date of their last tumor assessment. Participants who did not have any on-study tumor assessments were censored on the date they were randomized. Measurable disease was present if the patient had 1 or more measurable lesions.
Best Overall Response Rate
Best overall response rate was defined as the number of participants whose best response was either partial response (PR) or complete response (CR) divided by the number of participants in the treatment group. Overall tumor response was based on an integration of the evaluation of target, nontarget, and new lesions. CR=Disappearance of all clinical and radiologic evidence of target lesions. PR=At least 30% reduction in the sum of diameters of all target lesions; taking as reference the baseline study measurement. Changes in tumor measurements need not be confirmed by repeat measurements performed after the criteria for response were first met.
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
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related to study drug=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00883116
Brief Title
A Study of Ixabepilone as Second-line Therapy for Locally Advanced, Recurrent, or Metastatic Endometrial Cancer
Acronym
IXAMPLE2
Official Title
A Phase III, Open Label, Randomized, 2 Arm Study of Ixabepilone Administered Every 21 Days Versus Paclitaxel or Doxorubicin Administered Every 21 Days in Women With Advanced Endometrial Cancer Who Have Previously Been Treated With Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
Interim analysis results showed that ixabepilone did not improve survival compared with control chemotherapies.
Study Start Date
August 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
R-Pharm
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary purpose of this study is to investigate whether administration of ixabepilone results in superior outcome as assessed by overall survival compared with that achieved with standard chemotherapy (paclitaxel or doxorubicin) in women with advanced endometrial cancer that has progressed following first-line chemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
551 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ixabepilone, 40 mg/m^2, intravenously (IV)
Arm Type
Experimental
Arm Description
Participants received ixabepilone, 40 mg/m^2, given IV over 3 hours every 21 days until unacceptable toxicity or disease progression
Arm Title
Control chemotherapy (Paclitaxel or Doxorubicin)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ixabepilone
Other Intervention Name(s)
Ixempra, BMS-247550
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Other Intervention Name(s)
Adriamycin PFS/RDF, Adriacin, Adriblastina, Adriablastine, Adrimedac, DOXO-CELL, Doxolem, Doxorubin, Farmiblastina, Rubex
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol, Anzatax, Asotax, Bristaxol Praxel, Taxol Konzentrat, F1-106
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Survival was defined as the time from the date of randomization until the date of death. If the patient did not die, OS was censored on the last date he or she was known to be alive.
Time Frame
Date of randomization to date of death or last date censored to up to approximately 26 months
Secondary Outcome Measure Information:
Title
Progression-free Survival
Description
Progression-free survival was defined as the time from randomization to the date of documented disease progression. Patients who died without a reported prior progression were considered to have progressed on the date of their death. Those who did not progress or die were censored on the date of their last tumor assessment. Participants who did not have any on-study tumor assessments were censored on the date they were randomized. Measurable disease was present if the patient had 1 or more measurable lesions.
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
Title
Best Overall Response Rate
Description
Best overall response rate was defined as the number of participants whose best response was either partial response (PR) or complete response (CR) divided by the number of participants in the treatment group. Overall tumor response was based on an integration of the evaluation of target, nontarget, and new lesions. CR=Disappearance of all clinical and radiologic evidence of target lesions. PR=At least 30% reduction in the sum of diameters of all target lesions; taking as reference the baseline study measurement. Changes in tumor measurements need not be confirmed by repeat measurements performed after the criteria for response were first met.
Time Frame
Date of randomization and every 6 weeks to end of treatment (9 cycles, or approximately Day 189)
Title
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
Description
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related to study drug=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
Time Frame
From Day 1 (first dose) to 30 days past last dose (up to Day 219); 9 cycles, or 189 days + 30 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria
Women aged 18 years and older
Histologic or cytologic diagnosis of endometrial carcinoma
Evidence that the cancer is advanced, recurrent, or metastatic and not curable by local measures, such as surgery or radiation.
Karnofsky performance status >=70
Measurable or nonmeasurable disease that has progressed since last treatment.
If only disease is confined to a solitary lesion, its neoplastic nature must be confirmed by histology or cytology.
Disease in a previously irradiated field is acceptable as the only site of measurable disease only if there has been clear progression since completion of radiotherapy.
All therapy directed at endometrial cancer must be discontinued 21 days prior to start of treatment, except for hormonal therapy which must be discontinued at least 1 week prior to start of study treatment. Concurrent administration of hormone replacement therapy is allowed.
Prior therapy: Participants must have failed 1 prior platinum-based chemotherapeutic regimen for endometrial cancer. May have received 2 prior chemotherapy regimens if 1 regimen was given for stage I or II disease. May have received any number of prior non-cytotoxic regimens such as monoclonal antibodies, cytokines, signal transduction inhibitors, or hormonal therapy. Previous radiation therapy is allowed.
Key Exclusion Criteria
Carcinosarcoma (malignant mixed mullerian tumor)
Endometrial leiomyosarcoma and endometrial stromal sarcomas
Participants who received no prior chemotherapy for endometrial cancer or ≥2 prior chemotherapy regimens (exceptions defined in protocol)
Known brain metastases
Receipt of prior ixabepilone therapy
Concurrent active infection requiring antibiotics or other therapy
Concurrent unstable disease or other debilitating illness, such as congestive heart failure, unstable angina, myocardial infarction, or other cardiac disease that could jeopardize participation, within the last 6 months
For participants whose prior therapy did not include an anthracycline and therefore may be randomized to doxorubicin, left ventricular ejection fraction <50% as measured by multigated radionuclide angiography or echocardiography
History of malignancy, except nonmelanoma skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of the breast, within the last 5 years that has not been treated with chemotherapy
Known human immunodeficiency viral infection
Psychiatric disorders or other conditions rendering the participant incapable of complying with protocol requirements
Absolute neutrophil count <1500/mm^3
Platelets <100,000/mm^3
Hemoglobin <9 g/dL
Total bilirubin >1.5*upper limit of normal (ULN), except for those with Gilbert's disease
Aspartate aminotransferase or alanine aminotransferase >2.5*ULN
Serum creatinine >1.5*ULN
Grade ≥2 neuropathy (sensory or motor)
No concurrent therapy (chemotherapy, hormonal, or investigational) directed at endometrial cancer during the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
University Of South Alabama
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Rocky Mountain Gynecologic Oncology
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Peter E. Schwartz, Md
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510-3206
Country
United States
Facility Name
Hematology Oncology, P.C.
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Facility Name
Gynecologic Oncology Assoc.,Inc
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Florida Hospital Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Sarasota Memorial Health Care System
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
H. Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Georgia Health Science University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912-3335
Country
United States
Facility Name
Sudarshan K. Sharma, Md
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
Central Dupage Hospital Cancer Center
City
Warrenville
State/Province
Illinois
ZIP/Postal Code
60555
Country
United States
Facility Name
St. Vincent Hospital And Health Care Center, Inc.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Hematology And Oncology Specialists, Llc
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Women'S Health Specialists
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Sparrow Regional Cancer Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
University Of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455-0374
Country
United States
Facility Name
Saint Dominic's Gynecologic Oncology
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Matthew A Powell, Md
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Blumenthal Cancer Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Peggy And Charles Stephenson Oklahoma Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Tulsa Cancer Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Pennsylvania Oncology Hematology Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Magee-Womens Hospital Of Upmc Laboratory
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Women & Infants Hospital Of Ri
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
Facility Name
Cancer Centers Of The Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Tennessee Gynecologic Oncology Group, Llc
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
University Of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Local Institution
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DSK
Country
Argentina
Facility Name
Local Institution
City
La Rioja
ZIP/Postal Code
5300
Country
Argentina
Facility Name
Local Institution
City
Salta
ZIP/Postal Code
A4406CLA
Country
Argentina
Facility Name
Local Institution
City
Milton
State/Province
Queensland
ZIP/Postal Code
4064
Country
Australia
Facility Name
Local Institution
City
East Bentleigh
State/Province
Victoria
ZIP/Postal Code
3165
Country
Australia
Facility Name
Local Institution
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Local Institution
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Local Institution
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Local Institution
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Local Institution
City
Jau
State/Province
Sao Paulo
ZIP/Postal Code
17210-120
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Local Institution
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Local Institution
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1Z2
Country
Canada
Facility Name
Local Institution
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Local Institution
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Local Institution
City
Fleurimont
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Local Institution
City
Brno
ZIP/Postal Code
656 53
Country
Czech Republic
Facility Name
Local Institution
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
Local Institution
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Local Institution
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Local Institution
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75004
Country
France
Facility Name
Local Institution
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
Local Institution
City
Saint Herblain Cedex
ZIP/Postal Code
44805
Country
France
Facility Name
Local Institution
City
Villejuif Cedex
ZIP/Postal Code
94800
Country
France
Facility Name
Local Institution
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Local Institution
City
Miskolc
ZIP/Postal Code
H-3526
Country
Hungary
Facility Name
Local Institution
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Local Institution
City
Campobasso
ZIP/Postal Code
86100
Country
Italy
Facility Name
Local Institution
City
Meldola (fc)
ZIP/Postal Code
47014
Country
Italy
Facility Name
Local Institution
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Local Institution
City
Monza
ZIP/Postal Code
20052
Country
Italy
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Local Institution
City
Df
State/Province
Distrito Federal
ZIP/Postal Code
06720
Country
Mexico
Facility Name
Local Institution
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
06726
Country
Mexico
Facility Name
Local Institution
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
07760
Country
Mexico
Facility Name
Local Institution
City
Monterrey
State/Province
Distrito Federal
ZIP/Postal Code
64320
Country
Mexico
Facility Name
Local Institution
City
Tlalpan
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Local Institution
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico
Facility Name
Local Institution
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Local Institution
City
Oslo
ZIP/Postal Code
0310
Country
Norway
Facility Name
Local Institution
City
Lima
ZIP/Postal Code
34
Country
Peru
Facility Name
Local Institution
City
Lima
ZIP/Postal Code
Lima 11
Country
Peru
Facility Name
Local Institution
City
Lima
ZIP/Postal Code
LIMA 13
Country
Peru
Facility Name
Local Institution
City
Ivanovo
ZIP/Postal Code
153013
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
115 478
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Local Institution
City
Obninsk
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
Local Institution
City
St Pertersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Local Institution
City
St Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Local Institution
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Local Institution
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Local Institution
City
Linkoping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Local Institution
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Local Institution
City
Umea
ZIP/Postal Code
901 85
Country
Sweden
Facility Name
Local Institution
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Local Institution
City
Bristol
State/Province
Avon
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Local Institution
City
Glasgow
State/Province
Dumfries & Galloway
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Local Institution
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Local Institution
City
Leeds
State/Province
Yorkshire
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
25925990
Citation
McMeekin S, Dizon D, Barter J, Scambia G, Manzyuk L, Lisyanskaya A, Oaknin A, Ringuette S, Mukhopadhyay P, Rosenberg J, Vergote I. Phase III randomized trial of second-line ixabepilone versus paclitaxel or doxorubicin in women with advanced endometrial cancer. Gynecol Oncol. 2015 Jul;138(1):18-23. doi: 10.1016/j.ygyno.2015.04.026. Epub 2015 Apr 26.
Results Reference
derived
Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource
Learn more about this trial
A Study of Ixabepilone as Second-line Therapy for Locally Advanced, Recurrent, or Metastatic Endometrial Cancer
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