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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00883116




Registration number
NCT00883116
Ethics application status
Date submitted
16/04/2009
Date registered
17/04/2009
Date last updated
9/03/2017

Titles & IDs
Public title
A Study of Ixabepilone as Second-line Therapy for Locally Advanced, Recurrent, or Metastatic Endometrial Cancer
Scientific 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
Secondary ID [1] 0 0
2008-007167-16
Secondary ID [2] 0 0
CA163-196
Universal Trial Number (UTN)
Trial acronym
IXAMPLE2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometrial Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ixabepilone
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Paclitaxel

Experimental: Ixabepilone, 40 mg/m^2, intravenously (IV) - Participants received ixabepilone, 40 mg/m^2, given IV over 3 hours every 21 days until unacceptable toxicity or disease progression

Active Comparator: Control chemotherapy (Paclitaxel or Doxorubicin) - 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.


Treatment: Drugs: Ixabepilone


Treatment: Drugs: Doxorubicin


Treatment: Drugs: Paclitaxel
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Date of randomization to date of death or last date censored to up to approximately 26 months
Secondary outcome [1] 0 0
Progression-free Survival
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
Best Overall Response Rate
Timepoint [2] 0 0
Date of randomization and every 6 weeks to end of treatment (9 cycles, or approximately Day 189)
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
From Day 1 (first dose) to 30 days past last dose (up to Day 219); 9 cycles, or 189 days + 30 days

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2014
Sample size
Target
Accrual to date
Final
551
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Local Institution - Milton
Recruitment hospital [2] 0 0
Local Institution - East Bentleigh
Recruitment postcode(s) [1] 0 0
4064 - Milton
Recruitment postcode(s) [2] 0 0
3165 - East Bentleigh
Recruitment outside Australia
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United States of America
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Alabama
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Colorado
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Connecticut
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Florida
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Illinois
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Indiana
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Louisiana
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Michigan
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Santa Fe
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Salta
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Brescia
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Campobasso
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Meldola (fc)
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Milano
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Lima
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Madrid
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Valencia
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Goteborg
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Linkoping
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Stockholm
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Umea
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Uppsala
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United Kingdom
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Avon
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Dumfries & Galloway
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Nottinghamshire
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Yorkshire

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
R-Pharm
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00883116
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00883116