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← PEComa

NCT02494570 · STUDY IN CONTEXT

A Phase 2 Study of Nab-sirolimus (ABI-009) in Patients With Advanced Malignant PEComa

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 because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

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.

post-hoc · POSTED

The percentage of patients who achieve confirmed CR or PR or SD ≥12 weeks following study treatment initiation.

Source null

→

primary · POSTED

Best ORR was assessed by Independent Radiology Review using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Criteria. Best overall response was the best response recorded from the start of the study treatment until the end of treatment taking into account the requirement for confirmation. Per RECIST v1.1, best overall response assignment depended on the findings of both target and non-target disease and also took into consideration the appearance of new lesions. Overall response rate was defined as the percentage of patients who achieve a confirmed PR or CR per RECIST 1.1. At each timepoint, objective tumor response for target lesions were assessed as such: Complete Response (CR), disappearance of all target lesions, and pathological lymph nodes must have a reduction \<10 mm; Partial Response (PR), ≥30% decrease in the sum of the longest diameter of target lesions.

Efficacy Evaluable Patient Population

→

secondary · POSTED

The time from the start of CR or PR to the first date of documented PD or death.

Patients with a confirmed partial or complete response

→

secondary · POSTED

The time from the first dose date to the first observation of a disease progression or death due to any cause by 6 mo. Disease progression was assessed radiologically per RECIST v1.1, and was defined as ≥20% increase in the sum of diameters of target lesions, and absolute increase of ≥5 mm. PFS rate at 6 months was summarized using Kaplan-Meier methods (percentage rounded up to 1 digit decimal).

Efficacy Evaluable Patient Population

→

secondary · POSTED

The time from the first dose date to the first observation of a disease progression or death due to any cause.

Efficacy Evaluable Patient Population

→

secondary · POSTED

Defined as teh time from first dose date to the date of death due to any cause

Treated Patient Population

→

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-pecoma
nct id
NCT02494570
trial label
A Phase 2 Study of Nab-sirolimus (ABI-009) in Patients With Advanced Malignant PEComa
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
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-pecoma
    nct id
    NCT02494570
    outcome key
    om-0005
    source section id
    NCT02494570-om-0005
    source outcome index
    5
    endpoint
    Disease Control Rate
    endpoint definition
    The percentage of patients who achieve confirmed CR or PR or SD ≥12 weeks following study treatment initiation.
    time origin
    through study completion (up to 72 months)
    analysis role
    post-hoc
    reporting status
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-pecoma
    nct id
    NCT02494570
    outcome key
    om-0000
    source section id
    NCT02494570-om-0000
    source outcome index
    0
    endpoint
    Objective Overall Response Rate (ORR)
    endpoint definition
    Best ORR was assessed by Independent Radiology Review using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Criteria. Best overall response was the best response recorded from the start of the study treatment until the end of treatment taking into account the requirement for confirmation. Per RECIST v1.1, best overall response assignment depended on the findings of both target and non-target disease and also took into consideration the appearance of new lesions. Overall response rate was defined as the percentage of patients who achieve a confirmed PR or CR per RECIST 1.1. At each timepoint, objective tumor response for target lesions were assessed as such: Complete Response (CR), disappearance of all target lesions, and pathological lymph nodes must have a reduction \<10 mm; Partial Response (PR), ≥30% decrease in the sum of the longest diameter of target lesions.
    time origin
    through study completion (up to 72 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Efficacy Evaluable Patient Population
    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-pecoma
    nct id
    NCT02494570
    outcome key
    om-0001
    source section id
    NCT02494570-om-0001
    source outcome index
    1
    endpoint
    Duration of Response
    endpoint definition
    The time from the start of CR or PR to the first date of documented PD or death.
    time origin
    From Initial response until tumor progression, through study completion (up to 72 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients with a confirmed partial or complete response
    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-pecoma
    nct id
    NCT02494570
    outcome key
    om-0002
    source section id
    NCT02494570-om-0002
    source outcome index
    2
    endpoint
    Progression-free Survival Rate at 6 Months
    endpoint definition
    The time from the first dose date to the first observation of a disease progression or death due to any cause by 6 mo. Disease progression was assessed radiologically per RECIST v1.1, and was defined as ≥20% increase in the sum of diameters of target lesions, and absolute increase of ≥5 mm. PFS rate at 6 months was summarized using Kaplan-Meier methods (percentage rounded up to 1 digit decimal).
    time origin
    6 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Efficacy Evaluable Patient Population
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-pecoma
    nct id
    NCT02494570
    outcome key
    om-0003
    source section id
    NCT02494570-om-0003
    source outcome index
    3
    endpoint
    Progression-free Survival (Median)
    endpoint definition
    The time from the first dose date to the first observation of a disease progression or death due to any cause.
    time origin
    from start of treatment to first documented disease progression, through study completion (up to 72 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Efficacy Evaluable Patient Population
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-pecoma
    nct id
    NCT02494570
    outcome key
    om-0004
    source section id
    NCT02494570-om-0004
    source outcome index
    4
    endpoint
    Overall Survival
    endpoint definition
    Defined as teh time from first dose date to the date of death due to any cause
    time origin
    From start of treatment to date of death (of any cause), through study completion (up to 72 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Treated Patient Population
    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-pecoma
    nct id
    NCT02494570
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Nab-Sirolimus
    regimen
    Patients with malignant PEComa were treated with 100 mg/m2 nab-sirolimus (30 mins IV infusion) on Days 1 and 8 in a 21-day cycle.
    analyzed count
    31
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02494570-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-pecoma
    nct id
    NCT02494570
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Experimental: Nab-Sirolimus
    regimen
    Patients with malignant PEComa were treated with 100 mg/m2 nab-sirolimus (30 mins IV infusion) on Days 1 and 8 in a 21-day cycle.
    analyzed count
    12
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02494570-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-pecoma
    nct id
    NCT02494570
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Experimental: Nab-Sirolimus
    regimen
    Patients with malignant PEComa were treated with 100 mg/m2 nab-sirolimus (30 mins IV infusion) on Days 1 and 8 in a 21-day cycle
    analyzed count
    31
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02494570-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-pecoma
    nct id
    NCT02494570
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Experimental: Nab-Sirolimus
    regimen
    Patients with malignant PEComa were treated with 100 mg/m2 nab-sirolimus (30 mins IV infusion) on Days 1 and 8 in a 21-day cycle.
    analyzed count
    31
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02494570-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-pecoma
    nct id
    NCT02494570
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Experimental: Nab-Sirolimus
    regimen
    Patients with malignant PEComa were treated with 100 mg/m2 nab-sirolimus (30 mins IV infusion) on Days 1 and 8 in a 21-day cycle.
    analyzed count
    34
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02494570-om-0004#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-pecoma
    nct id
    NCT02494570
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Experimental: Nab-Sirolimus
    regimen
    Patients with malignant PEComa were treated with 100 mg/m2 nab-sirolimus (30 mins IV infusion) on Days 1 and 8 in a 21-day cycle.
    analyzed count
    31
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02494570-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-pecoma
    nct id
    NCT02494570
    harm key
    EG000
    source section id
    NCT02494570-ae
    event group key
    EG000
    event group label
    Experimental: Nab-Sirolimus
    serious affected
    16
    serious at risk
    34
    other affected
    34
    other at risk
    34
    frequency threshold
    5
    collection period
    Safety and tolerability were monitored through continuous reporting of treatment-emergent and treatment-related adverse events (AEs) and serious AEs throughout the study, from the time the patient signed informed consent until 28 days after the last dose of study drug, up to 72 months.
    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