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NCT02669017 · OUTCOME

Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) 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

AUCinf 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 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

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 day*ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: 15 μg/kg Q3W432173Not reportedNot reportedNot reported
Part 1: 30 μg/kg Q3W2001663Not reportedNot reportedNot reported
Part 1: 60 μg/kg Q3W53334002Not reportedNot reportedNot reported
Part 1: 90 μg/kg Q3W56227170Not reportedNot reportedNot reported
Parts 1 and 2: 120 μg/kg Q3W102326220Not reportedNot reportedNot reported
Parts 1 and 2: 150 μg/kg Q3W114988175Not reportedNot reportedNot reported
Part 1: 200 μg/kg Q3W2917425838Not reportedNot reportedNot reported
Part 1: 200 μg/kg Q6W3262919488Not reportedNot reportedNot reported
PBD conjugated Ab: 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
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 day*ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: 15 μg/kg Q3W869NANot reportedNot reportedStandard deviation could not be determined as only one participant had evaluable data.
Part 1: 90 μg/kg Q3W16409NANot reportedNot reportedStandard deviation could not be determined as only one participant had evaluable data.
Parts 1 and 2: 120 μg/kg Q3W132928495Not reportedNot reportedNot reported
Parts 1 and 2: 150 μg/kg Q3W126928968Not reportedNot reportedNot reported
Part 1: 200 μg/kg Q3W3899153597Not reportedNot reportedNot reported
Part 1: 200 μg/kg Q6W4395224032Not reportedNot reportedNot reported
total Ab: 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
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 day*ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Parts 1 and 2: 150 μg/kg Q3W0.154NANot 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
        173
        value
        432
      2. group Id
        OG001
        spread
        663
        value
        2001
      3. group Id
        OG002
        spread
        4002
        value
        5333
      4. group Id
        OG003
        spread
        7170
        value
        5622
      5. group Id
        OG004
        spread
        6220
        value
        10232
      6. group Id
        OG005
        spread
        8175
        value
        11498
      7. group Id
        OG006
        spread
        25838
        value
        29174
      8. group Id
        OG007
        spread
        19488
        value
        32629
    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. 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 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
        869
      2. comment
        Standard deviation could not be determined as only one participant had evaluable data.
        group Id
        OG003
        spread
        NA
        value
        16409
      3. group Id
        OG004
        spread
        8495
        value
        13292
      4. group Id
        OG005
        spread
        8968
        value
        12692
      5. group Id
        OG006
        spread
        53597
        value
        38991
      6. group Id
        OG007
        spread
        24032
        value
        43952
    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. 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 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
        0.154
    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
      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
description
AUCinf 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 Infinity (AUCinf) 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