Study Stopped
Interim analysis results showed that ixabepilone did not improve survival compared with control chemotherapies.
A Study of Ixabepilone as Second-line Therapy for Locally Advanced, Recurrent, or Metastatic Endometrial Cancer
IXAMPLE2
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
2 other identifiers
interventional
551
19 countries
93
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2009
Typical duration for phase_3
93 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2009
CompletedFirst Posted
Study publicly available on registry
April 17, 2009
CompletedStudy Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedResults Posted
Study results publicly available
March 14, 2014
CompletedMarch 9, 2017
January 1, 2017
2.8 years
April 16, 2009
December 6, 2013
January 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Date of randomization to date of death or last date censored to up to approximately 26 months
Secondary Outcomes (3)
Progression-free Survival
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
Best Overall Response Rate
Date of randomization and every 6 weeks to end of treatment (9 cycles, or approximately Day 189)
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
From Day 1 (first dose) to 30 days past last dose (up to Day 219); 9 cycles, or 189 days + 30 days
Study Arms (2)
Ixabepilone, 40 mg/m^2, intravenously (IV)
EXPERIMENTALParticipants received ixabepilone, 40 mg/m\^2, given IV over 3 hours every 21 days until unacceptable toxicity or disease progression
Control chemotherapy (Paclitaxel or Doxorubicin)
ACTIVE COMPARATORParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- R-Pharmlead
Study Sites (93)
University Of South Alabama
Mobile, Alabama, 36604, United States
Rocky Mountain Gynecologic Oncology
Englewood, Colorado, 80113, United States
Peter E. Schwartz, Md
New Haven, Connecticut, 06510-3206, United States
Hematology Oncology, P.C.
Stamford, Connecticut, 06902, United States
Gynecologic Oncology Assoc.,Inc
Hollywood, Florida, 33021, United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804, United States
Sarasota Memorial Health Care System
Sarasota, Florida, 34239, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
Georgia Health Science University
Augusta, Georgia, 30912-3335, United States
Sudarshan K. Sharma, Md
Hinsdale, Illinois, 60521, United States
Central Dupage Hospital Cancer Center
Warrenville, Illinois, 60555, United States
St. Vincent Hospital And Health Care Center, Inc.
Indianapolis, Indiana, 46260, United States
Hematology And Oncology Specialists, Llc
Marrero, Louisiana, 70072, United States
Women'S Health Specialists
Rockville, Maryland, 20852, United States
Sparrow Regional Cancer Center
Lansing, Michigan, 48912, United States
University Of Minnesota
Minneapolis, Minnesota, 55455-0374, United States
Saint Dominic's Gynecologic Oncology
Jackson, Mississippi, 39216, United States
Matthew A Powell, Md
St Louis, Missouri, 63110, United States
Blumenthal Cancer Center
Charlotte, North Carolina, 28204, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Peggy And Charles Stephenson Oklahoma Cancer Center
Oklahoma City, Oklahoma, 73104, United States
Tulsa Cancer Institute
Tulsa, Oklahoma, 74136, United States
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, 19106, United States
Magee-Womens Hospital Of Upmc Laboratory
Pittsburgh, Pennsylvania, 15213, United States
Women & Infants Hospital Of Ri
Providence, Rhode Island, 02908, United States
Cancer Centers Of The Carolinas
Greenville, South Carolina, 29615, United States
Tennessee Gynecologic Oncology Group, Llc
Chattanooga, Tennessee, 37403, United States
University Of Virginia
Charlottesville, Virginia, 22908, United States
Local Institution
La Rioja, La Rioja Province, 5300, Argentina
Local Institution
Salta, Salta Province, A4406CLA, Argentina
Local Institution
Rosario, Santa Fe Province, S2000DSK, Argentina
Local Institution
Milton, Queensland, 4064, Australia
Local Institution
East Bentleigh, Victoria, 3165, Australia
Local Institution
Ghent, 9000, Belgium
Local Institution
Leuven, B-3000, Belgium
Local Institution
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Local Institution
Barretos, São Paulo, 14784-400, Brazil
Local Institution
Jaú, São Paulo, 17210-120, Brazil
Local Institution
São Paulo, São Paulo, 01246-000, Brazil
Local Institution
Calgary, Alberta, T2N 4N2, Canada
Local Institution
Surrey, British Columbia, V3V 1Z2, Canada
Local Institution
Vancouver, British Columbia, V5Z 4E6, Canada
Local Institution
Halifax, Nova Scotia, B3H 1V7, Canada
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Toronto, Ontario, M5G 2M9, Canada
Local Institution
Fleurimont, Quebec, J1H 5N4, Canada
Local Institution
Montreal, Quebec, H2L 4M1, Canada
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Brno, 656 53, Czechia
Local Institution
Hradec Králové, 500 05, Czechia
Local Institution
Copenhagen, 2100, Denmark
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Herlev, 2730, Denmark
Local Institution
Odense C, 5000, Denmark
Local Institution
Paris, 75004, France
Local Institution
Poitiers, 86000, France
Local Institution
Saint-Herblain, 44805, France
Local Institution
Villejuif, 94800, France
Local Institution
Athens, 11528, Greece
Local Institution
Budapest, 1122, Hungary
Local Institution
Miskolc, H-3526, Hungary
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Brescia, 25123, Italy
Local Institution
Campobasso, 86100, Italy
Local Institution
Meldola (fc), 47014, Italy
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Milan, 20141, Italy
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Monza, 20052, Italy
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Roma, 00168, Italy
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Guadalajara, Jalisco, 44340, Mexico
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Df, Mexico City, 06720, Mexico
Local Institution
Mexico City, Mexico City, 06726, Mexico
Local Institution
Mexico City, Mexico City, 07760, Mexico
Local Institution
Monterrey, Mexico City, 64320, Mexico
Local Institution
Tlalpan, Mexico City, 14080, Mexico
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Bergen, 5021, Norway
Local Institution
Oslo, 0310, Norway
Local Institution
Lima, Lima Province, 34, Peru
Local Institution
Lima, Lima Province, Lima 11, Peru
Local Institution
Lima, Lima Province, LIMA 13, Peru
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Ivanovo, 153013, Russia
Local Institution
Moscow, 115 478, Russia
Local Institution
Moscow, 117997, Russia
Local Institution
Obninsk, 249036, Russia
Local Institution
Saint Pertersburg, 198255, Russia
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Saint Petersburg, 197758, Russia
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Barcelona, 08035, Spain
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Madrid, 28040, Spain
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Valencia, 46009, Spain
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Gothenburg, 413 45, Sweden
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Linköping, 581 85, Sweden
Local Institution
Stockholm, 171 76, Sweden
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Umeå, 901 85, Sweden
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Uppsala, 751 85, Sweden
Local Institution
Bristol, Avon, BS2 8ED, United Kingdom
Local Institution
Glasgow, Dumfries & Galloway, G12 0YN, United Kingdom
Local Institution
Nottingham, Nottinghamshire, NG5 1PB, United Kingdom
Local Institution
Leeds, Yorkshire, LS9 7TF, United Kingdom
Related Publications (1)
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.
PMID: 25925990DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This study was terminated per Data Monitoring Committee. Results from an interim analysis showed that there was no favorable benefit/risk ratio with ixabepilone and that ixabepilone did not improve survival compared with control chemotherapies.
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2009
First Posted
April 17, 2009
Study Start
August 1, 2009
Primary Completion
June 1, 2012
Study Completion
February 1, 2014
Last Updated
March 9, 2017
Results First Posted
March 14, 2014
Record last verified: 2017-01