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NCT01631552 · OUTCOME

PK Parameter: AUC0-inf of Total Antibody, SN-38 Glucuronide, Total SN-38, Sacituzumab Govitecan-hziy, and Free SN-38

Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults With Epithelial Cancer · Source last updated 2021-08-12

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

Measure
GEOMETRIC_MEAN
Unit
microgram*hour per liter
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1: Preinfusion, 30 minutes and 3-4 hours post infusion, then 1 day, 2 days, 3 days, and 7 days later (1 Cycle = 21 days). Infusion duration: 3 hours (± 30 minutes) for 1st infusion; 1-2 hour (± 30 minutes) for subsequent infusions

What was measured

AUC0-inf was determined for 5 analytes: total antibody, SN-38 glucuronide, total SN-38, free SN-38, and sacituzumab govitecan-hziy, a derived antibody drug conjugate (ADC) concentration. SN-38 is one of the components of sacituzumab govitecan-hziy. AUC0-inf is defined as area under the serum concentration-time curve from time 0 extrapolated to infinity. The dose level evaluated for PK analysis was 10 mg/kg.

Analysis population: Participants with epithelial cancer that involved any one of the following with available data were analyzed: cervical cancer, colorectal cancer, endometrial cancer, epithelial ovarian cancer, esophageal cancer, gastric adenocarcinoma, glioblastoma multiforme, head \& neck cancers- squamouse cell, hepatocellular carcinoma, hormone-refractory prostate cancer, metastatic, non-small-cell lung cancer, pancreatic ductal adenocarcinoma, renal cell cancer, small-cell lung cancer, non TNBC, TNBC and mUC.

Groups in this outcome

SG 10 mg/kg

Participants included adults with the following tumor types: cervical cancer, colorectal cancer, endometrial cancer, epithelial ovarian cancer, esophageal cancer, gastric adenocarcinoma, glioblastoma multiforme, head and neck cancers- squamous cell, hepatocellular carcinoma, hormone-refractory prostate cancer, metastatic, non-small-cell lung cancer, pancreatic ductal adenocarcinoma, renal cell cancer, small-cell lung cancer, non-triple-negative breast cancer, triple-negative breast cancer, and metastatic urothelial cancer. All participants received SG 10 mg/kg of body weight by IV infusion on Days 1 and 8 of a 21-day treatment 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
SG 10 mg/kg128

Reported measurements

Total Antibody

Analysis denominator · Participants

GroupSource count
SG 10 mg/kg5
Values in microgram*hour per liter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
SG 10 mg/kg2510020.5Not reportedNot reportedNot reported
SN-38G

Analysis denominator · Participants

GroupSource count
SG 10 mg/kg63
Values in microgram*hour per liter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
SG 10 mg/kg0.85050.7Not reportedNot reportedNot reported
Total SN-38

Analysis denominator · Participants

GroupSource count
SG 10 mg/kg128
Values in microgram*hour per liter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
SG 10 mg/kg10725.5Not reportedNot reportedNot reported
Sacituzumab Govitecan-hziy (SG)

Analysis denominator · Participants

GroupSource count
SG 10 mg/kg120
Values in microgram*hour per liter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
SG 10 mg/kg505024.4Not reportedNot reportedNot reported
Free SN-38

Analysis denominator · Participants

GroupSource count
SG 10 mg/kg95
Values in microgram*hour per liter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
SG 10 mg/kg3.0856.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.5
        value
        25100
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      units
      Participants
    title
    Total Antibody
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        50.7
        value
        0.850
    denoms
    1. counts
      1. group Id
        OG000
        value
        63
      units
      Participants
    title
    SN-38G
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.5
        value
        107
    denoms
    1. counts
      1. group Id
        OG000
        value
        128
      units
      Participants
    title
    Total SN-38
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.4
        value
        5050
    denoms
    1. counts
      1. group Id
        OG000
        value
        120
      units
      Participants
    title
    Sacituzumab Govitecan-hziy (SG)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        56.6
        value
        3.08
    denoms
    1. counts
      1. group Id
        OG000
        value
        95
      units
      Participants
    title
    Free SN-38
denoms
  1. counts
    1. group Id
      OG000
      value
      128
    units
    Participants
description
AUC0-inf was determined for 5 analytes: total antibody, SN-38 glucuronide, total SN-38, free SN-38, and sacituzumab govitecan-hziy, a derived antibody drug conjugate (ADC) concentration. SN-38 is one of the components of sacituzumab govitecan-hziy. AUC0-inf is defined as area under the serum concentration-time curve from time 0 extrapolated to infinity. The dose level evaluated for PK analysis was 10 mg/kg.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants included adults with the following tumor types: cervical cancer, colorectal cancer, endometrial cancer, epithelial ovarian cancer, esophageal cancer, gastric adenocarcinoma, glioblastoma multiforme, head and neck cancers- squamous cell, hepatocellular carcinoma, hormone-refractory prostate cancer, metastatic, non-small-cell lung cancer, pancreatic ductal adenocarcinoma, renal cell cancer, small-cell lung cancer, non-triple-negative breast cancer, triple-negative breast cancer, and metastatic urothelial cancer. All participants received SG 10 mg/kg of body weight by IV infusion on Days 1 and 8 of a 21-day treatment cycle.
    id
    OG000
    title
    SG 10 mg/kg
param Type
GEOMETRIC_MEAN
population Description
Participants with epithelial cancer that involved any one of the following with available data were analyzed: cervical cancer, colorectal cancer, endometrial cancer, epithelial ovarian cancer, esophageal cancer, gastric adenocarcinoma, glioblastoma multiforme, head \& neck cancers- squamouse cell, hepatocellular carcinoma, hormone-refractory prostate cancer, metastatic, non-small-cell lung cancer, pancreatic ductal adenocarcinoma, renal cell cancer, small-cell lung cancer, non TNBC, TNBC and mUC.
reporting Status
POSTED
time Frame
Cycle 1: Preinfusion, 30 minutes and 3-4 hours post infusion, then 1 day, 2 days, 3 days, and 7 days later (1 Cycle = 21 days). Infusion duration: 3 hours (± 30 minutes) for 1st infusion; 1-2 hour (± 30 minutes) for subsequent infusions
title
PK Parameter: AUC0-inf of Total Antibody, SN-38 Glucuronide, Total SN-38, Sacituzumab Govitecan-hziy, and Free SN-38
type
SECONDARY
unit Of Measure
microgram*hour per liter

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Preserved source evidence · Not medical advice