TriangleNCT01637961 · STUDY IN CONTEXT
Alisertib in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus
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
Aurora A Kinase expression will be assessed for associations with patient demographics and clinical outcome (response, PFS at 6 months, PFS, and OS).
Whether or not the patient survived progression-free for at least 6 months. 90% confidence interval (Bonferroni Corrected). Progression is defined 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. (Note: the appearance of one or more new lesions is also considered progressions). Progression includes the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Complete and Partial Tumor Response by RECIST 1.1. Patient response uses best overall response while on therapy. Complete response is defined as the disappearance of all target lesions and non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in the short axis to \<10 mm. 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. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation.
The observed length of life from entry into the study to death or the date of last contact.
Number of Participants With Adverse Events as Assessed by NCI CTCAE Version 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.
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
- NCT01637961
- trial label
- Alisertib in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus
- 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
- 6
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01637961
- outcome key
- om-0005
- source section id
- NCT01637961-om-0005
- source outcome index
- 5
- endpoint
- Aurora A Kinase Expression
- endpoint definition
- Aurora A Kinase expression will be assessed for associations with patient demographics and clinical outcome (response, PFS at 6 months, PFS, and OS).
- time origin
- Up to 5 years
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population note
- Source null
- 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
- NCT01637961
- outcome key
- om-0000
- source section id
- NCT01637961-om-0000
- source outcome index
- 0
- endpoint
- Progression-free Survival (PFS) > 6 Months
- endpoint definition
- Whether or not the patient survived progression-free for at least 6 months. 90% confidence interval (Bonferroni Corrected). Progression is defined 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. (Note: the appearance of one or more new lesions is also considered progressions). Progression includes the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
- time origin
- Assessed every other cycle for the first 6 months; then every 3 months from the date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.
- 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
- NCT01637961
- outcome key
- om-0001
- source section id
- NCT01637961-om-0001
- source outcome index
- 1
- endpoint
- Tumor Response
- endpoint definition
- Complete and Partial Tumor Response by RECIST 1.1. Patient response uses best overall response while on therapy. Complete response is defined as the disappearance of all target lesions and non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in the short axis to \<10 mm. 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. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation.
- time origin
- Every other cycle for the first 6 months; then every 3 months thereafter until withdrawal from study treatment or disease progression is confirmed.
- 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
- NCT01637961
- outcome key
- om-0002
- source section id
- NCT01637961-om-0002
- source outcome index
- 2
- endpoint
- Overall Survival
- endpoint definition
- The observed length of life from entry into the study to death or the date of last contact.
- time origin
- From study entry to death or last contact, up to 5 years.
- 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
- NCT01637961
- outcome key
- om-0003
- source section id
- NCT01637961-om-0003
- source outcome index
- 3
- endpoint
- Number of Participants With Adverse Events as Assessed by NCI CTCAE Version 4.0
- endpoint definition
- Number of Participants With Adverse Events as Assessed by NCI CTCAE Version 4.0
- time origin
- Every cycle during treatment and 30 days after the last treatment, up to 5 years.
- 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
- NCT01637961
- outcome key
- om-0004
- source section id
- NCT01637961-om-0004
- source outcome index
- 4
- 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
- every other cycle for the first 6 months; then every 3 months thereafter until disease progression is confirmed; up to 5 years
- 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
- NCT01637961
- outcome key
- om-0000
- arm key
- OG000
- arm label
- MLN8237
- regimen
- MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
- analyzed count
- 21
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01637961-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01637961
- outcome key
- om-0001
- arm key
- OG000
- arm label
- MLN8237
- regimen
- MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
- analyzed count
- 21
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01637961-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01637961
- outcome key
- om-0002
- arm key
- OG000
- arm label
- MLN8237
- regimen
- MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
- analyzed count
- 21
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01637961-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01637961
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Grade 0
- regimen
- Number of patients who did not experience the specified AE.
- analyzed count
- 21
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01637961-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01637961
- outcome key
- om-0003
- 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
- 21
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01637961-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01637961
- outcome key
- om-0003
- 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
- 21
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01637961-om-0003#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01637961
- outcome key
- om-0003
- 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
- 21
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01637961-om-0003#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01637961
- outcome key
- om-0003
- 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
- 21
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01637961-om-0003#groups/OG004
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01637961
- outcome key
- om-0003
- 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
- 21
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01637961-om-0003#groups/OG005
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01637961
- outcome key
- om-0004
- arm key
- OG000
- arm label
- MLN8237
- regimen
- MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
- analyzed count
- 21
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01637961-om-0004#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-leiomyosarcoma
- nct id
- NCT01637961
- harm key
- EG000
- source section id
- NCT01637961-ae
- event group key
- EG000
- event group label
- MLN8237
- serious affected
- 5
- serious at risk
- 21
- other affected
- 21
- other at risk
- 21
- frequency threshold
- 0
- collection period
- All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
- 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