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NCT02669017 · OUTCOME

Apparent Clearance (CL) at Steady State 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
liters/day
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

CL of 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 Q6W13

Reported measurements

PBD conjugated Ab: Cycle 1

Analysis denominator · Participants

GroupSource count
Part 1: 15 μg/kg Q3W3
Part 1: 30 μg/kg Q3W2
Part 1: 60 μg/kg Q3W2
Part 1: 90 μg/kg Q3W2
Parts 1 and 2: 120 μg/kg Q3W15
Parts 1 and 2: 150 μg/kg Q3W47
Part 1: 200 μg/kg Q3W4
Part 1: 200 μg/kg Q6W13
Values in liters/day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: 15 μg/kg Q3W2.490.978Not reportedNot reportedNot reported
Part 1: 30 μg/kg Q3W1.080.164Not reportedNot reportedNot reported
Part 1: 60 μg/kg Q3W0.6960.444Not reportedNot reportedNot reported
Part 1: 90 μg/kg Q3W7.138.91Not reportedNot reportedNot reported
Parts 1 and 2: 120 μg/kg Q3W2.094.07Not reportedNot reportedNot reported
Parts 1 and 2: 150 μg/kg Q3W3.848.53Not reportedNot reportedNot reported
Part 1: 200 μg/kg Q3W3.115.30Not reportedNot reportedNot reported
Part 1: 200 μg/kg Q6W12.639.4Not reportedNot reportedNot reported
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 liters/day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: 15 μg/kg Q3W1.781.80Not reportedNot reportedNot reported
Part 1: 30 μg/kg Q3W0.6460.348Not reportedNot reportedNot reported
Part 1: 60 μg/kg Q3W0.4150.205Not reportedNot reportedNot reported
Part 1: 90 μg/kg Q3W19.640.6Not reportedNot reportedNot reported
Parts 1 and 2: 120 μg/kg Q3W17.8109Not reportedNot reportedNot reported
Parts 1 and 2: 150 μg/kg Q3W0.9862.48Not reportedNot reportedNot reported
Part 1: 200 μg/kg Q3W0.4070.143Not reportedNot reportedNot reported
Part 1: 200 μg/kg Q6W0.3490.210Not reportedNot reportedNot reported
total Ab: Cycle 1

Analysis denominator · Participants

GroupSource count
Part 1: 15 μg/kg Q3W1
Part 1: 30 μg/kg Q3W0
Part 1: 60 μg/kg Q3W0
Part 1: 90 μg/kg Q3W1
Parts 1 and 2: 120 μg/kg Q3W12
Parts 1 and 2: 150 μg/kg Q3W37
Part 1: 200 μg/kg Q3W2
Part 1: 200 μg/kg Q6W12
Values in liters/day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: 15 μg/kg Q3W1.28NANot reportedNot reportedStandard deviation could not be determined as only one participant had evaluable data.
Part 1: 90 μg/kg Q3W0.640NANot reportedNot reportedStandard deviation could not be determined as only one participant had evaluable data.
Parts 1 and 2: 120 μg/kg Q3W2.475.00Not reportedNot reportedNot reported
Parts 1 and 2: 150 μg/kg Q3W3.878.95Not reportedNot reportedNot reported
Part 1: 200 μg/kg Q3W7.129.62Not reportedNot reportedNot reported
Part 1: 200 μg/kg Q6W2.025.11Not reportedNot reportedNot reported
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 liters/day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: 15 μg/kg Q3W1.761.71Not reportedNot reportedNot reported
Part 1: 30 μg/kg Q3W0.5770.309Not reportedNot reportedNot reported
Part 1: 60 μg/kg Q3W38.165.5Not reportedNot reportedNot reported
Part 1: 90 μg/kg Q3W1.422.06Not reportedNot reportedNot reported
Parts 1 and 2: 120 μg/kg Q3W0.5810.660Not reportedNot reportedNot reported
Parts 1 and 2: 150 μg/kg Q3W1.052.91Not reportedNot reportedNot reported
Part 1: 200 μg/kg Q3W0.4170.161Not reportedNot reportedNot reported
Part 1: 200 μg/kg Q6W0.3230.187Not 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 Q3W1
Part 1: 200 μg/kg Q3W0
Part 1: 200 μg/kg Q6W0
Values in liters/day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Parts 1 and 2: 150 μg/kg Q3W627NANot reportedNot reportedStandard deviation could not be determined as only one participant had evaluable data.
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. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.978
        value
        2.49
      2. group Id
        OG001
        spread
        0.164
        value
        1.08
      3. group Id
        OG002
        spread
        0.444
        value
        0.696
      4. group Id
        OG003
        spread
        8.91
        value
        7.13
      5. group Id
        OG004
        spread
        4.07
        value
        2.09
      6. group Id
        OG005
        spread
        8.53
        value
        3.84
      7. group Id
        OG006
        spread
        5.30
        value
        3.11
      8. group Id
        OG007
        spread
        39.4
        value
        12.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        15
      6. group Id
        OG005
        value
        47
      7. group Id
        OG006
        value
        4
      8. group Id
        OG007
        value
        13
      units
      Participants
    title
    PBD conjugated Ab: Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.80
        value
        1.78
      2. group Id
        OG001
        spread
        0.348
        value
        0.646
      3. group Id
        OG002
        spread
        0.205
        value
        0.415
      4. group Id
        OG003
        spread
        40.6
        value
        19.6
      5. group Id
        OG004
        spread
        109
        value
        17.8
      6. group Id
        OG005
        spread
        2.48
        value
        0.986
      7. group Id
        OG006
        spread
        0.143
        value
        0.407
      8. group Id
        OG007
        spread
        0.210
        value
        0.349
    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. categories
    1. measurements
      1. comment
        Standard deviation could not be determined as only one participant had evaluable data.
        group Id
        OG000
        spread
        NA
        value
        1.28
      2. comment
        Standard deviation could not be determined as only one participant had evaluable data.
        group Id
        OG003
        spread
        NA
        value
        0.640
      3. group Id
        OG004
        spread
        5.00
        value
        2.47
      4. group Id
        OG005
        spread
        8.95
        value
        3.87
      5. group Id
        OG006
        spread
        9.62
        value
        7.12
      6. group Id
        OG007
        spread
        5.11
        value
        2.02
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        12
      6. group Id
        OG005
        value
        37
      7. group Id
        OG006
        value
        2
      8. group Id
        OG007
        value
        12
      units
      Participants
    title
    total Ab: Cycle 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.71
        value
        1.76
      2. group Id
        OG001
        spread
        0.309
        value
        0.577
      3. group Id
        OG002
        spread
        65.5
        value
        38.1
      4. group Id
        OG003
        spread
        2.06
        value
        1.42
      5. group Id
        OG004
        spread
        0.660
        value
        0.581
      6. group Id
        OG005
        spread
        2.91
        value
        1.05
      7. group Id
        OG006
        spread
        0.161
        value
        0.417
      8. group Id
        OG007
        spread
        0.187
        value
        0.323
    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. categories
    1. measurements
      1. comment
        Standard deviation could not be determined as only one participant had evaluable data.
        group Id
        OG005
        spread
        NA
        value
        627
    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
        1
      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
      13
    units
    Participants
description
CL of 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
Apparent Clearance (CL) at Steady State for ADCT-402
type
SECONDARY
unit Of Measure
liters/day

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