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NCT02494570 · OUTCOME

Objective Overall Response Rate (ORR)

A Phase 2 Study of Nab-sirolimus (ABI-009) in Patients With Advanced Malignant PEComa · Source last updated 2023-04-07

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
through study completion (up to 72 months)

What was measured

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.

Analysis population: Efficacy Evaluable Patient Population

Groups in this outcome

Nab-Sirolimus

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Nab-Sirolimus31

Reported measurements

Source class 1

Best Overall Confirmed Complete Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nab-Sirolimus2Not reportedNot reportedNot reportedNot reported

Best Overall Confirmed Partial Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nab-Sirolimus10Not reportedNot reportedNot reportedNot reported

Best Overall Stable Disease

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nab-Sirolimus16Not reportedNot reportedNot reportedNot reported

Best Overall Progressive Disease

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nab-Sirolimus3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      title
      Best Overall Confirmed Complete Response
    2. measurements
      1. group Id
        OG000
        value
        10
      title
      Best Overall Confirmed Partial Response
    3. measurements
      1. group Id
        OG000
        value
        16
      title
      Best Overall Stable Disease
    4. measurements
      1. group Id
        OG000
        value
        3
      title
      Best Overall Progressive Disease
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    units
    Participants
description
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.
groups
  1. description
    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.
    id
    OG000
    title
    Nab-Sirolimus
param Type
COUNT_OF_PARTICIPANTS
population Description
Efficacy Evaluable Patient Population
reporting Status
POSTED
time Frame
through study completion (up to 72 months)
title
Objective Overall Response Rate (ORR)
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice