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NCT02669017 · OUTCOME

Area Under the Serum Concentration-Time Curve From Time 0 to the End of the Dosing Interval (AUCtau) for ADCT-402

Study of ADCT-402 in Patients With Relapsed or Refractory B-cell Lineage Non Hodgkin Lymphoma (B-NHL) · Source last updated 2021-05-19

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

Measure
MEAN
Unit
day*ng/mL
Interval / dispersion
Standard Deviation
Time frame
Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)

What was measured

AUCtau for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199). Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.

Analysis population: Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.

Groups in this outcome

Part 1: 15 μg/kg Q3W

Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).

Part 1: 30 μg/kg Q3W

Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).

Part 1: 60 μg/kg Q3W

Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).

Part 1: 90 μg/kg Q3W

Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).

Parts 1 and 2: 120 μg/kg Q3W

Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.

Parts 1 and 2: 150 μg/kg Q3W

Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.

Part 1: 200 μg/kg Q3W

Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.

Part 1: 200 μg/kg Q6W

Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 6 week cycle (Q6W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.

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

Analysis denominator · Participants

GroupSource count
Part 1: 15 μg/kg Q3W4
Part 1: 30 μg/kg Q3W4
Part 1: 60 μg/kg Q3W3
Part 1: 90 μg/kg Q3W5
Parts 1 and 2: 120 μg/kg Q3W40
Parts 1 and 2: 150 μg/kg Q3W72
Part 1: 200 μg/kg Q3W11
Part 1: 200 μg/kg Q6W12

Reported measurements

PBD conjugated Ab: Cycle 1

Analysis denominator · Participants

GroupSource count
Part 1: 15 μg/kg Q3W0
Part 1: 30 μg/kg Q3W0
Part 1: 60 μg/kg Q3W0
Part 1: 90 μg/kg Q3W0
Parts 1 and 2: 120 μg/kg Q3W0
Parts 1 and 2: 150 μg/kg Q3W0
Part 1: 200 μg/kg Q3W0
Part 1: 200 μg/kg Q6W0
PBD conjugated Ab: Cycle 2

Analysis denominator · Participants

GroupSource count
Part 1: 15 μg/kg Q3W4
Part 1: 30 μg/kg Q3W4
Part 1: 60 μg/kg Q3W2
Part 1: 90 μg/kg Q3W5
Parts 1 and 2: 120 μg/kg Q3W40
Parts 1 and 2: 150 μg/kg Q3W72
Part 1: 200 μg/kg Q3W11
Part 1: 200 μg/kg Q6W12
Values in day*ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: 15 μg/kg Q3W22852928Not reportedNot reportedNot reported
Part 1: 30 μg/kg Q3W34581426Not reportedNot reportedNot reported
Part 1: 60 μg/kg Q3W105751121Not reportedNot reportedNot reported
Part 1: 90 μg/kg Q3W1017111244Not reportedNot reportedNot reported
Parts 1 and 2: 120 μg/kg Q3W198908968Not reportedNot reportedNot reported
Parts 1 and 2: 150 μg/kg Q3W2285912080Not reportedNot reportedNot reported
Part 1: 200 μg/kg Q3W393629800Not reportedNot reportedNot reported
Part 1: 200 μg/kg Q6W3846623514Not reportedNot reportedNot reported
total Ab: Cycle 1

Analysis denominator · Participants

GroupSource count
Part 1: 15 μg/kg Q3W0
Part 1: 30 μg/kg Q3W0
Part 1: 60 μg/kg Q3W0
Part 1: 90 μg/kg Q3W0
Parts 1 and 2: 120 μg/kg Q3W0
Parts 1 and 2: 150 μg/kg Q3W0
Part 1: 200 μg/kg Q3W0
Part 1: 200 μg/kg Q6W0
total Ab: Cycle 2

Analysis denominator · Participants

GroupSource count
Part 1: 15 μg/kg Q3W4
Part 1: 30 μg/kg Q3W4
Part 1: 60 μg/kg Q3W3
Part 1: 90 μg/kg Q3W4
Parts 1 and 2: 120 μg/kg Q3W39
Parts 1 and 2: 150 μg/kg Q3W72
Part 1: 200 μg/kg Q3W11
Part 1: 200 μg/kg Q6W12
Values in day*ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: 15 μg/kg Q3W26363387Not reportedNot reportedNot reported
Part 1: 30 μg/kg Q3W46622096Not reportedNot reportedNot reported
Part 1: 60 μg/kg Q3W102118827Not reportedNot reportedNot reported
Part 1: 90 μg/kg Q3W1714115029Not reportedNot reportedNot reported
Parts 1 and 2: 120 μg/kg Q3W2424710902Not reportedNot reportedNot reported
Parts 1 and 2: 150 μg/kg Q3W2804115312Not reportedNot reportedNot reported
Part 1: 200 μg/kg Q3W4646912675Not reportedNot reportedNot reported
Part 1: 200 μg/kg Q6W4852428858Not reportedNot reportedNot reported
SG3199: Cycle 1

Analysis denominator · Participants

GroupSource count
Part 1: 15 μg/kg Q3W0
Part 1: 30 μg/kg Q3W0
Part 1: 60 μg/kg Q3W0
Part 1: 90 μg/kg Q3W0
Parts 1 and 2: 120 μg/kg Q3W0
Parts 1 and 2: 150 μg/kg Q3W0
Part 1: 200 μg/kg Q3W0
Part 1: 200 μg/kg Q6W0
SG3199: Cycle 2

Analysis denominator · Participants

GroupSource count
Part 1: 15 μg/kg Q3W0
Part 1: 30 μg/kg Q3W0
Part 1: 60 μg/kg Q3W0
Part 1: 90 μg/kg Q3W0
Parts 1 and 2: 120 μg/kg Q3W0
Parts 1 and 2: 150 μg/kg Q3W0
Part 1: 200 μg/kg Q3W0
Part 1: 200 μg/kg Q6W0
Complete source fields
classes
  1. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      units
      Participants
    title
    PBD conjugated Ab: Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        2928
        value
        2285
      2. group Id
        OG001
        spread
        1426
        value
        3458
      3. group Id
        OG002
        spread
        1121
        value
        10575
      4. group Id
        OG003
        spread
        11244
        value
        10171
      5. group Id
        OG004
        spread
        8968
        value
        19890
      6. group Id
        OG005
        spread
        12080
        value
        22859
      7. group Id
        OG006
        spread
        9800
        value
        39362
      8. group Id
        OG007
        spread
        23514
        value
        38466
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        5
      5. group Id
        OG004
        value
        40
      6. group Id
        OG005
        value
        72
      7. group Id
        OG006
        value
        11
      8. group Id
        OG007
        value
        12
      units
      Participants
    title
    PBD conjugated Ab: Cycle 2
  3. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      units
      Participants
    title
    total Ab: Cycle 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        3387
        value
        2636
      2. group Id
        OG001
        spread
        2096
        value
        4662
      3. group Id
        OG002
        spread
        8827
        value
        10211
      4. group Id
        OG003
        spread
        15029
        value
        17141
      5. group Id
        OG004
        spread
        10902
        value
        24247
      6. group Id
        OG005
        spread
        15312
        value
        28041
      7. group Id
        OG006
        spread
        12675
        value
        46469
      8. group Id
        OG007
        spread
        28858
        value
        48524
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        39
      6. group Id
        OG005
        value
        72
      7. group Id
        OG006
        value
        11
      8. group Id
        OG007
        value
        12
      units
      Participants
    title
    total Ab: Cycle 2
  5. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      units
      Participants
    title
    SG3199: Cycle 1
  6. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      units
      Participants
    title
    SG3199: Cycle 2
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      5
    5. group Id
      OG004
      value
      40
    6. group Id
      OG005
      value
      72
    7. group Id
      OG006
      value
      11
    8. group Id
      OG007
      value
      12
    units
    Participants
description
AUCtau for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199). Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    OG000
    title
    Part 1: 15 μg/kg Q3W
  2. description
    Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    OG001
    title
    Part 1: 30 μg/kg Q3W
  3. description
    Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    OG002
    title
    Part 1: 60 μg/kg Q3W
  4. description
    Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    OG003
    title
    Part 1: 90 μg/kg Q3W
  5. description
    Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
    id
    OG004
    title
    Parts 1 and 2: 120 μg/kg Q3W
  6. description
    Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
    id
    OG005
    title
    Parts 1 and 2: 150 μg/kg Q3W
  7. description
    Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
    id
    OG006
    title
    Part 1: 200 μg/kg Q3W
  8. description
    Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 6 week cycle (Q6W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
    id
    OG007
    title
    Part 1: 200 μg/kg Q6W
param Type
MEAN
population Description
Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
reporting Status
POSTED
time Frame
Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)
title
Area Under the Serum Concentration-Time Curve From Time 0 to the End of the Dosing Interval (AUCtau) for ADCT-402
type
SECONDARY
unit Of Measure
day*ng/mL

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice