Trial · NCT01168232

Ixabepilone in Treating Patients With Recurrent or Persistent Uterine Cancer

NCT01168232, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2017-01-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Ixabepilone in Treating Patients With Recurrent or Persistent Uterine Cancer. Trials, record NCT01168232. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01168232

On this page

Trial

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

Title: Ixabepilone in Treating Patients With Recurrent or Persistent Uterine Cancer
NCT number: NCT01168232
Status: Completed
Phases: Phase 2
Enrollment: 42 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Recurrent Uterine Corpus Sarcoma, Uterine Carcinosarcoma
Interventions: Ixabepilone, Laboratory Biomarker Analysis
First posted: 2010-07-23
Last updated: 2019-08-08
Results first posted: 2017-01-23

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Objective Tumor Response	Every other cycle for first 6 months; then every 3 months thereafter until completion of study treatment; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.1 cycle is 21 days	Proportion of participants with objective tumor response. Objective tumor response is defined as complete or partial tumor response as assessed by RECIST 1.1.
Primary	Adverse Events (Grade 3 or Higher) During Treatment Period.	During treatment and up to 30 days after stopping the study treatment	Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0
Secondary	Progression-free Survival	From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.	Progression-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. Progression is assessed by RECIST 1.1
Secondary	Overall Survival	From study entry to death or last contact, up to 5 years of follow-up.	Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.

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	Objective Tumor Response	Every other cycle for first 6 months; then every 3 months thereafter until completion of study treatment; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.1 cycle is 21 days	Eligible and Treated Patients. Measure of dispersion is 95% One-sided confidence Interval	percentage	NUMBER
PRIMARY	Adverse Events (Grade 3 or Higher) During Treatment Period.	During treatment and up to 30 days after stopping the study treatment	Eligible and Treated Participants	participants	NUMBER
SECONDARY	Progression-free Survival	From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.	Eligible and Treated Patients	months	MEDIAN
SECONDARY	Overall Survival	From study entry to death or last contact, up to 5 years of follow-up.	Eligible and Treated Patients	months	MEDIAN

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
Objective Tumor Response	Ixabepilone		11.8	95% Confidence Interval 4.2 to 100	percentage
Adverse Events (Grade 3 or Higher) During Treatment Period.	Ixabepilone	Leukopenia	15		participants
Adverse Events (Grade 3 or Higher) During Treatment Period.	Ixabepilone	Thrombocytopenia	0		participants
Adverse Events (Grade 3 or Higher) During Treatment Period.	Ixabepilone	Neutropenia	16		participants
Adverse Events (Grade 3 or Higher) During Treatment Period.	Ixabepilone	Anemia	5		participants
Adverse Events (Grade 3 or Higher) During Treatment Period.	Ixabepilone	Other Investigations	4		participants
Adverse Events (Grade 3 or Higher) During Treatment Period.	Ixabepilone	Other Blood/lymphatics	2		participants
Adverse Events (Grade 3 or Higher) During Treatment Period.	Ixabepilone	Cardiac Disorders	1		participants
Adverse Events (Grade 3 or Higher) During Treatment Period.	Ixabepilone	Gastrointestinal disorders	6		participants
Adverse Events (Grade 3 or Higher) During Treatment Period.	Ixabepilone	General disorders and administration site conditio	9		participants

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Ixabepilone	42
Overall Study	COMPLETED	Ixabepilone	34
Overall Study	NOT COMPLETED	Ixabepilone	8

Source ClinicalTrials.gov

Adverse events135

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	Anemia	Blood and lymphatic system disorders	Ixabepilone	33	34
other	Sinus Bradycardia	Cardiac disorders	Ixabepilone	1	34
other	Sinus Tachycardia	Cardiac disorders	Ixabepilone	2	34
other	Chest Pain - Cardiac	Cardiac disorders	Ixabepilone	1	34
other	Tinnitus	Ear and labyrinth disorders	Ixabepilone	3	34
other	Hearing Impaired	Ear and labyrinth disorders	Ixabepilone	4	34
other	Blurred Vision	Eye disorders	Ixabepilone	3	34
other	Dysphagia	Gastrointestinal disorders	Ixabepilone	2	34
other	Dyspepsia	Gastrointestinal disorders	Ixabepilone	3	34
other	Dry Mouth	Gastrointestinal disorders	Ixabepilone	1	34

1 to 10 of 135Source ClinicalTrials.gov

See all 135 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ixabepilone
Total, other adverse events	Ixabepilone	34	34
Total, serious adverse events	Ixabepilone	17	34

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants2

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
U10CA180868	NRG Oncology Network Group Operations Center	WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S.	NRG ONCOLOGY FOUNDATION, INC.	NATIONAL CANCER INSTITUTE	2014 to 2026	NIH RePORTER
U10CA027469	Gynecologic Oncology Group	DISAIA, PHILIP J.	GYNECOLOGIC ONCOLOGY GROUP	NATIONAL CANCER INSTITUTE	1985 to 2013	NIH RePORTER

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/NCT01168232

GET https://conductscience.org/api/trials/v1/NCT01168232/events?page=2

API reference For AI assistants