Endometrial CancerPhase 3IXAMPLE2NCT00883116
A Study of Ixabepilone as Second-line Therapy for Locally Advanced, Recurrent, or Metastatic Endometrial Cancer
A Phase 3 study testing Ixabepilone, Doxorubicin and Paclitaxel in people with Endometrial Cancer, run by R-Pharm at 93 sites in 19 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Ixabepilone, Doxorubicin and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 551 participants
- Where
- 93 sitesin 19 countries
- Study dates
- Aug 2009to Feb 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
93 sites in 19 countries.
93 sites in 19 countries
United States28 sites
Georgia Health Science University
Augusta, Georgia, 30912-3335
Blumenthal Cancer Center
Charlotte, North Carolina, 28204
University Of Virginia
Charlottesville, Virginia, 22908
Tennessee Gynecologic Oncology Group, Llc
Chattanooga, Tennessee, 37403
Duke University Medical Center
Durham, North Carolina, 27710
Rocky Mountain Gynecologic Oncology
Englewood, Colorado, 80113
Cancer Centers Of The Carolinas
Greenville, South Carolina, 29615
Sudarshan K. Sharma, Md
Hinsdale, Illinois, 60521
Gynecologic Oncology Assoc.,Inc
Hollywood, Florida, 33021
St. Vincent Hospital And Health Care Center, Inc.
Indianapolis, Indiana, 46260
Saint Dominic's Gynecologic Oncology
Jackson, Mississippi, 39216
Sparrow Regional Cancer Center
Lansing, Michigan, 48912
Hematology And Oncology Specialists, Llc
Marrero, Louisiana, 70072
University Of Minnesota
Minneapolis, Minnesota, 55455-0374
University Of South Alabama
Mobile, Alabama, 36604
Peter E. Schwartz, Md
New Haven, Connecticut, 06510-3206
Peggy And Charles Stephenson Oklahoma Cancer Center
Oklahoma City, Oklahoma, 73104
Florida Hospital Cancer Institute
Orlando, Florida, 32804
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, 19106
Magee-Womens Hospital Of Upmc Laboratory
Pittsburgh, Pennsylvania, 15213
Women & Infants Hospital Of Ri
Providence, Rhode Island, 02908
Women'S Health Specialists
Rockville, Maryland, 20852
Sarasota Memorial Health Care System
Sarasota, Florida, 34239
Matthew A Powell, Md
St Louis, Missouri, 63110
Hematology Oncology, P.C.
Stamford, Connecticut, 06902
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
Tulsa Cancer Institute
Tulsa, Oklahoma, 74136
Central Dupage Hospital Cancer Center
Warrenville, Illinois, 60555
Canada7 sites
Local Institution
Calgary, Alberta, T2N 4N2
Local Institution
Fleurimont, Quebec, J1H 5N4
Local Institution
Halifax, Nova Scotia, B3H 1V7
Local Institution
Montreal, Quebec, H2L 4M1
Local Institution
Surrey, British Columbia, V3V 1Z2
Local Institution
Toronto, Ontario, M5G 2M9
Local Institution
Vancouver, British Columbia, V5Z 4E6
Italy6 sites
Local Institution
Brescia, 25123
Local Institution
Campobasso, 86100
Local Institution
Meldola (fc), 47014
Local Institution
Milan, 20141
Local Institution
Monza, 20052
Local Institution
Roma, 00168
Mexico6 sites
Local Institution
Df, Mexico City, 06720
Local Institution
Guadalajara, Jalisco, 44340
Local Institution
Mexico City, Mexico City, 06726
Local Institution
Mexico City, Mexico City, 07760
Local Institution
Monterrey, Mexico City, 64320
Local Institution
Tlalpan, Mexico City, 14080
Russia6 sites
Local Institution
Ivanovo, 153013
Local Institution
Moscow, 115 478
Local Institution
Moscow, 117997
Local Institution
Obninsk, 249036
Local Institution
Saint Pertersburg, 198255
Local Institution
Saint Petersburg, 197758
Sweden5 sites
Local Institution
Gothenburg, 413 45
Local Institution
Linköping, 581 85
Local Institution
Stockholm, 171 76
Local Institution
Umeå, 901 85
Local Institution
Uppsala, 751 85
Brazil4 sites
Local Institution
Barretos, São Paulo, 14784-400
Local Institution
Jaú, São Paulo, 17210-120
Local Institution
Porto Alegre, Rio Grande do Sul, 90610-000
Local Institution
São Paulo, São Paulo, 01246-000
France4 sites
Local Institution
Paris, 75004
Local Institution
Poitiers, 86000
Local Institution
Saint-Herblain, 44805
Local Institution
Villejuif, 94800
United Kingdom4 sites
Local Institution
Bristol, Avon, BS2 8ED
Local Institution
Glasgow, Dumfries & Galloway, G12 0YN
Local Institution
Leeds, Yorkshire, LS9 7TF
Local Institution
Nottingham, Nottinghamshire, NG5 1PB
Argentina3 sites
Local Institution
La Rioja, La Rioja Province, 5300
Local Institution
Rosario, Santa Fe Province, S2000DSK
Local Institution
Salta, Salta Province, A4406CLA
Denmark3 sites
Local Institution
Copenhagen, 2100
Local Institution
Herlev, 2730
Local Institution
Odense C, 5000
Peru3 sites
Local Institution
Lima, Lima Province, 34
Local Institution
Lima, Lima Province, Lima 11
Local Institution
Lima, Lima Province, LIMA 13
Spain3 sites
Local Institution
Barcelona, 08035
Local Institution
Madrid, 28040
Local Institution
Valencia, 46009
Australia2 sites
Local Institution
East Bentleigh, Victoria, 3165
Local Institution
Milton, Queensland, 4064
Czechia2 sites
Local Institution
Brno, 656 53
Local Institution
Hradec Králové, 500 05
Hungary2 sites
Local Institution
Budapest, 1122
Local Institution
Miskolc, H-3526
About this study
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
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.
- Conditions
- Endometrial Cancer
- Being tested
- Ixabepilone, Doxorubicin, Paclitaxel
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IxabepiloneDrug
Also called Ixempra, BMS-247550
DoxorubicinDrug
Also called Adriamycin PFS/RDF, Adriacin, Adriblastina, Adriablastine
PaclitaxelDrug
Also called Taxol, Anzatax, Asotax, Bristaxol Praxel
| Study group | Role | What they receive |
|---|---|---|
| Ixabepilone, 40 mg/m^2, intravenously (IV) | Experimental | Participants received ixabepilone, 40 mg/m^2, given IV over 3 hours every 21 days until unacceptable toxicity or disease progression Receives: Drug: Ixabepilone |
| Control chemotherapy (Paclitaxel or Doxorubicin) | Active comparator | 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. Receives: Drug: Doxorubicin; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Date of randomization to date of death or last date censored to up to approximately 26 months
Secondary outcomes (3)
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.
Measured: 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
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.
Measured: 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
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.
Measured: From Day 1 (first dose) to 30 days past last dose (up to Day 219); 9 cycles, or 189 days + 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2009 (estimated)
- Study startAug 2009
- Primary completionJun 2012
- Study completionFeb 2014
Why it stopped: Interim analysis results showed that ixabepilone did not improve survival compared with control chemotherapies.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 551 participants (actual)
Sponsor and investigators
- Lead sponsor
- R-Pharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00883116
- Sponsor's protocol ID
- CA163-196
- Other IDs
- 2008-007167-16, 2008
- Acronym
- IXAMPLE2
- Status last verified
- Jan 2017
- First submitted
- 16 Apr 2009
- Last updated
- 9 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 25925990
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00883116
- Acronym / sponsor ID
- IXAMPLE2 / CA163-196
- Conditions
- Endometrial Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis results showed that ixabepilone did not improve survival compared with control chemotherapies.
- Enrolment
- 551 participants (actual)
- Lead sponsor
- R-PharmIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 17 Apr 2009 (estimated)
- Results
- Posted 14 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ixabepilone, 40 mg/m^2, intravenously (IV) | Experimental | Drug: IxabepiloneParticipants 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 comparator | Drug: Doxorubicin, Drug: PaclitaxelParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IxabepiloneAlso: Ixempra, BMS-247550 | Drug | Ixabepilone, 40 mg/m^2, intravenously (IV) |
| DoxorubicinAlso: Adriamycin PFS/RDF, Adriacin, Adriblastina, Adriablastine | Drug | Control chemotherapy (Paclitaxel or Doxorubicin) |
| PaclitaxelAlso: Taxol, Anzatax, Asotax, Bristaxol Praxel | Drug | Control chemotherapy (Paclitaxel or Doxorubicin) |
Primary outcome
Overall Survival (OS)
Time frame: Date of randomization to date of death or last date censored to up to approximately 26 months
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.
3 secondary outcomes
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
Best Overall Response Rate
Time frame: 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
Time frame: From Day 1 (first dose) to 30 days past last dose (up to Day 219); 9 cycles, or 189 days + 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25925990McMeekin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
93 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ixabepilone, Doxorubicin and Paclitaxel in people with Endometrial Cancer, run by R-Pharm at 93 sites in 19 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 93 sites in United States, Canada, Italy, Mexico, Russia and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Date of randomization to date of death or last date censored to up to approximately 26 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00883116, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.