Trial · NCT00883116

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

NCT00883116, Phase 3, Terminated, R-Pharm; results first posted 2014-03-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Ixabepilone as Second-line Therapy for Locally Advanced, Recurrent, or Metastatic Endometrial Cancer. Trials, record NCT00883116. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00883116

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Ixabepilone as Second-line Therapy for Locally Advanced, Recurrent, or Metastatic Endometrial Cancer
NCT number: NCT00883116
Status: Terminated
Phases: Phase 3
Enrollment: 551 participants, actual
Lead sponsor: R-Pharm
Conditions: Endometrial Cancer
Interventions: Ixabepilone, Doxorubicin, Paclitaxel
First posted: 2009-04-17
Last updated: 2017-03-09
Results first posted: 2014-03-14
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.

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Survival (OS)	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.
Secondary	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	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.
Secondary	Best Overall Response Rate	Date of randomization and every 6 weeks to end of treatment (9 cycles, or approximately Day 189)	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.
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	From Day 1 (first dose) to 30 days past last dose (up to Day 219); 9 cycles, or 189 days + 30 days	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.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival (OS)	Date of randomization to date of death or last date censored to up to approximately 26 months	All randomized participants	Months	MEDIAN
SECONDARY	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	All participants with measurable disease at randomization	Months	MEDIAN
SECONDARY	Best Overall Response Rate	Date of randomization and every 6 weeks to end of treatment (9 cycles, or approximately Day 189)	All randomized participants with measurable disease	Percentage of participants	NUMBER
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	From Day 1 (first dose) to 30 days past last dose (up to Day 219); 9 cycles, or 189 days + 30 days	All participants who received at least 1 dose of ixabepilone	Participants	NUMBER

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Overall Survival (OS)	Ixabepilone, 40 mg/m^2, Intravenously (IV)		10.9	95% Confidence Interval 8.5 to 12.7	Months
Overall Survival (OS)	Control With Chemotherapy (Paclitaxel or Doxorubicin)		12.3	95% Confidence Interval 10.7 to 15.4	Months
Progression-free Survival	Ixabepilone, 40 mg/m^2, Intravenously (IV)		3.4	95% Confidence Interval 2.8 to 4.2	Months
Progression-free Survival	Control With Chemotherapy (Paclitaxel or Doxorubicin)		4.0	95% Confidence Interval 2.7 to 4.3	Months
Best Overall Response Rate	Ixabepilone, 40 mg/m^2, Intravenously (IV)		15.2	95% Confidence Interval 10.8 to 20.6	Percentage of participants
Best Overall Response Rate	Control With Chemotherapy (Paclitaxel or Doxorubicin)		15.7	95% Confidence Interval 11.2 to 21.1	Percentage of participants
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	Ixabepilone, 40 mg/m^2, Intravenously (IV)	Any SAEs	89		Participants
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	Control With Chemotherapy (Paclitaxel or Doxorubicin)	Any SAEs	70		Participants
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	Ixabepilone, 40 mg/m^2, Intravenously (IV)	Any SAE related to study drug	43		Participants
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	Control With Chemotherapy (Paclitaxel or Doxorubicin)	Any SAE related to study drug	29		Participants

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Ixabepilone, 40 mg/m^2, IV	248
Overall Study	STARTED	Control Chemotherapy	248
Overall Study	Received Treatment	Ixabepilone, 40 mg/m^2, IV	248
Overall Study	Received Treatment	Control Chemotherapy	239
Overall Study	COMPLETED	Ixabepilone, 40 mg/m^2, IV	39
Overall Study	COMPLETED	Control Chemotherapy	29
Overall Study	NOT COMPLETED	Ixabepilone, 40 mg/m^2, IV	209
Overall Study	NOT COMPLETED	Control Chemotherapy	219

Source ClinicalTrials.gov

Adverse events543

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Dizziness	Nervous system disorders	Ixabepilone, 40 mg/m^2, Intravenously (IV)	24	248
other	Dizziness	Nervous system disorders	Control With Chemotherapy (Doxorubicin, 60 mg/m^2, IV)	10	171
other	Dizziness	Nervous system disorders	Control With Chemotherapy (Paclitaxel, 175 mg/m^2, IV)	1	68
other	Dyspepsia	Gastrointestinal disorders	Ixabepilone, 40 mg/m^2, Intravenously (IV)	17	248
other	Dyspepsia	Gastrointestinal disorders	Control With Chemotherapy (Doxorubicin, 60 mg/m^2, IV)	14	171
other	Dyspepsia	Gastrointestinal disorders	Control With Chemotherapy (Paclitaxel, 175 mg/m^2, IV)	0	68
other	Decreased appetite	Metabolism and nutrition disorders	Ixabepilone, 40 mg/m^2, Intravenously (IV)	82	248
other	Decreased appetite	Metabolism and nutrition disorders	Control With Chemotherapy (Doxorubicin, 60 mg/m^2, IV)	45	171
other	Decreased appetite	Metabolism and nutrition disorders	Control With Chemotherapy (Paclitaxel, 175 mg/m^2, IV)	12	68
other	Hypoaesthesia	Nervous system disorders	Ixabepilone, 40 mg/m^2, Intravenously (IV)	3	248

1 to 10 of 543Source ClinicalTrials.gov

See all 543 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ixabepilone, 40 mg/m^2, Intravenously (IV)
Total, all-cause mortality	Control With Chemotherapy (Doxorubicin, 60 mg/m^2, IV)
Total, all-cause mortality	Control With Chemotherapy (Paclitaxel, 175 mg/m^2, IV)
Total, other adverse events	Ixabepilone, 40 mg/m^2, Intravenously (IV)	233	248
Total, other adverse events	Control With Chemotherapy (Doxorubicin, 60 mg/m^2, IV)	160	171
Total, other adverse events	Control With Chemotherapy (Paclitaxel, 175 mg/m^2, IV)	63	68
Total, serious adverse events	Ixabepilone, 40 mg/m^2, Intravenously (IV)	89	248
Total, serious adverse events	Control With Chemotherapy (Doxorubicin, 60 mg/m^2, IV)	59	171
Total, serious adverse events	Control With Chemotherapy (Paclitaxel, 175 mg/m^2, IV)	11	68

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25925990	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00883116

GET https://conductscience.org/api/trials/v1/NCT00883116/events?page=2

API reference For AI assistants