TriangleNCT01220609 · STUDY IN CONTEXT
Ixabepilone in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus Previously Treated With Chemotherapy
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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
Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0
Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.
Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Reported safety
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-leiomyosarcoma
- nct id
- NCT01220609
- trial label
- Ixabepilone in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus Previously Treated With Chemotherapy
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01220609
- outcome key
- om-0000
- source section id
- NCT01220609-om-0000
- source outcome index
- 0
- endpoint
- Tumor Response
- endpoint definition
- Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
- time origin
- Every other cycle for the first 6 months; then every 3 months thereafter; up to 5 years.
- analysis role
- primary
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01220609
- outcome key
- om-0001
- source section id
- NCT01220609-om-0001
- source outcome index
- 1
- endpoint
- Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0
- endpoint definition
- Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0
- time origin
- Every cycle until completion of study treatment up to 30 days after stopping study treatment
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible and evaluable patients.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01220609
- outcome key
- om-0002
- source section id
- NCT01220609-om-0002
- source outcome index
- 2
- endpoint
- Progression-free Survival
- endpoint definition
- Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01220609
- outcome key
- om-0003
- source section id
- NCT01220609-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
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01220609
- 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
- 23
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01220609-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01220609
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Grade 0
- regimen
- Number of patients who did not experience the specified AE.
- analyzed count
- 23
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01220609-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01220609
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Grade 1 (CTCAE v 4.0)
- regimen
- Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
- analyzed count
- 23
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01220609-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01220609
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Grade 2 (CTCAE v 4.0)
- regimen
- Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0
- analyzed count
- 23
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01220609-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01220609
- outcome key
- om-0001
- arm key
- OG003
- arm label
- Grade 3 (CTCAE v 4.0)
- regimen
- Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0
- analyzed count
- 23
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01220609-om-0001#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01220609
- outcome key
- om-0001
- arm key
- OG004
- arm label
- Grade 4 (CTCAE v 4.0)
- regimen
- Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0
- analyzed count
- 23
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01220609-om-0001#groups/OG004
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01220609
- outcome key
- om-0001
- arm key
- OG005
- arm label
- Grade 5 (CTCAE v 4.0)
- regimen
- Number of patients who experienced a grade 5 event using Common Terminology Criteria version 4.0
- analyzed count
- 23
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01220609-om-0001#groups/OG005
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01220609
- 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
- 23
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01220609-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01220609
- 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
- 23
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01220609-om-0003#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01220609
- harm key
- EG000
- source section id
- NCT01220609-ae
- event group key
- EG000
- event group label
- Ixabepilone
- serious affected
- 9
- serious at risk
- 23
- other affected
- 23
- other at risk
- 23
- frequency threshold
- 0
- collection period
- All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
- 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