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← recurrent Uterine Sarcoma

NCT01168232 · STUDY IN CONTEXT

Ixabepilone in Treating Patients With Recurrent or Persistent Uterine Cancer

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Proportion of participants with objective tumor response. Objective tumor response is defined as complete or partial tumor response as assessed by RECIST 1.1.

Eligible and Treated Patients. Measure of dispersion is 95% One-sided confidence Interval

→

primary · POSTED

Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0

Eligible and Treated Participants

→

secondary · POSTED

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

Eligible and Treated Patients

→

secondary · POSTED

Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.

Eligible and Treated Patients

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-uterine-sarcoma-recurrent-8e0b2edc
nct id
NCT01168232
trial label
Ixabepilone in Treating Patients With Recurrent or Persistent Uterine Cancer
applicability
unclear
applicability note
Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
4
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-uterine-sarcoma-recurrent-8e0b2edc
    nct id
    NCT01168232
    outcome key
    om-0000
    source section id
    NCT01168232-om-0000
    source outcome index
    0
    endpoint
    Objective Tumor Response
    endpoint definition
    Proportion of participants with objective tumor response. Objective tumor response is defined as complete or partial tumor response as assessed by RECIST 1.1.
    time origin
    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
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible and Treated Patients. Measure of dispersion is 95% One-sided confidence Interval
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-uterine-sarcoma-recurrent-8e0b2edc
    nct id
    NCT01168232
    outcome key
    om-0001
    source section id
    NCT01168232-om-0001
    source outcome index
    1
    endpoint
    Adverse Events (Grade 3 or Higher) During Treatment Period.
    endpoint definition
    Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0
    time origin
    During treatment and up to 30 days after stopping the study treatment
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible and Treated Participants
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-uterine-sarcoma-recurrent-8e0b2edc
    nct id
    NCT01168232
    outcome key
    om-0002
    source section id
    NCT01168232-om-0002
    source outcome index
    2
    endpoint
    Progression-free Survival
    endpoint definition
    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
    time origin
    From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible and Treated Patients
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-uterine-sarcoma-recurrent-8e0b2edc
    nct id
    NCT01168232
    outcome key
    om-0003
    source section id
    NCT01168232-om-0003
    source outcome index
    3
    endpoint
    Overall Survival
    endpoint definition
    Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
    time origin
    From study entry to death or last contact, up to 5 years of follow-up.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible and Treated Patients
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-uterine-sarcoma-recurrent-8e0b2edc
    nct id
    NCT01168232
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Ixabepilone
    regimen
    Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
    analyzed count
    34
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01168232-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-uterine-sarcoma-recurrent-8e0b2edc
    nct id
    NCT01168232
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Ixabepilone
    regimen
    Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
    analyzed count
    34
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01168232-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-uterine-sarcoma-recurrent-8e0b2edc
    nct id
    NCT01168232
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Ixabepilone
    regimen
    Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
    analyzed count
    34
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01168232-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-uterine-sarcoma-recurrent-8e0b2edc
    nct id
    NCT01168232
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Ixabepilone
    regimen
    Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
    analyzed count
    34
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01168232-om-0003#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-uterine-sarcoma-recurrent-8e0b2edc
    nct id
    NCT01168232
    harm key
    EG000
    source section id
    NCT01168232-ae
    event group key
    EG000
    event group label
    Ixabepilone
    serious affected
    17
    serious at risk
    34
    other affected
    34
    other at risk
    34
    frequency threshold
    0
    collection period
    All Adverse Events (AEs) occurring during the patient's treatment and up to 30 days after stopping the study treatment are reported. The amount of time on study is specific to each patient.
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice