Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02669017 · OUTCOME

Accumulation Index (AI) 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
ratio
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

AI for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199). AI is the ratio of area under the serum concentration-time curve (AUC) from 0 to 21 days for Cycle 2 divided by AUC from 0 to 21 days for Cycle 1 (Q3W schedule: 3 week cycle length; Q6W schedule: 6 week cycle length). It is the increase in drug plasma concentration after multiple dosing until a steady state is reached. 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 Q3W2
Part 1: 90 μg/kg Q3W4
Parts 1 and 2: 120 μg/kg Q3W38
Parts 1 and 2: 150 μg/kg Q3W69
Part 1: 200 μg/kg Q3W11
Part 1: 200 μg/kg Q6W12

Reported measurements

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 Q3W4
Parts 1 and 2: 120 μg/kg Q3W38
Parts 1 and 2: 150 μg/kg Q3W69
Part 1: 200 μg/kg Q3W11
Part 1: 200 μg/kg Q6W12
Values in ratio · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: 15 μg/kg Q3W1.120.173Not reportedNot reportedNot reported
Part 1: 30 μg/kg Q3W1.370.264Not reportedNot reportedNot reported
Part 1: 60 μg/kg Q3W1.700.467Not reportedNot reportedNot reported
Part 1: 90 μg/kg Q3W1.420.399Not reportedNot reportedNot reported
Parts 1 and 2: 120 μg/kg Q3W1.470.369Not reportedNot reportedNot reported
Parts 1 and 2: 150 μg/kg Q3W1.460.368Not reportedNot reportedNot reported
Part 1: 200 μg/kg Q3W1.760.385Not reportedNot reportedNot reported
Part 1: 200 μg/kg Q6W1.230.160Not reportedNot reportedNot reported
total Ab: Cycle 2

Analysis denominator · Participants

GroupSource count
Part 1: 15 μg/kg Q3W4
Part 1: 30 μg/kg Q3W3
Part 1: 60 μg/kg Q3W2
Part 1: 90 μg/kg Q3W4
Parts 1 and 2: 120 μg/kg Q3W34
Parts 1 and 2: 150 μg/kg Q3W66
Part 1: 200 μg/kg Q3W10
Part 1: 200 μg/kg Q6W12
Values in ratio · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: 15 μg/kg Q3W1.150.229Not reportedNot reportedNot reported
Part 1: 30 μg/kg Q3W1.350.252Not reportedNot reportedNot reported
Part 1: 60 μg/kg Q3W1.710.325Not reportedNot reportedNot reported
Part 1: 90 μg/kg Q3W1.800.962Not reportedNot reportedNot reported
Parts 1 and 2: 120 μg/kg Q3W1.620.492Not reportedNot reportedNot reported
Parts 1 and 2: 150 μg/kg Q3W1.630.486Not reportedNot reportedNot reported
Part 1: 200 μg/kg Q3W1.780.418Not reportedNot reportedNot reported
Part 1: 200 μg/kg Q6W1.360.314Not reportedNot reportedNot reported
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
        0.173
        value
        1.12
      2. group Id
        OG001
        spread
        0.264
        value
        1.37
      3. group Id
        OG002
        spread
        0.467
        value
        1.70
      4. group Id
        OG003
        spread
        0.399
        value
        1.42
      5. group Id
        OG004
        spread
        0.369
        value
        1.47
      6. group Id
        OG005
        spread
        0.368
        value
        1.46
      7. group Id
        OG006
        spread
        0.385
        value
        1.76
      8. group Id
        OG007
        spread
        0.160
        value
        1.23
    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
        4
      5. group Id
        OG004
        value
        38
      6. group Id
        OG005
        value
        69
      7. group Id
        OG006
        value
        11
      8. group Id
        OG007
        value
        12
      units
      Participants
    title
    PBD conjugated Ab: Cycle 2
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.229
        value
        1.15
      2. group Id
        OG001
        spread
        0.252
        value
        1.35
      3. group Id
        OG002
        spread
        0.325
        value
        1.71
      4. group Id
        OG003
        spread
        0.962
        value
        1.80
      5. group Id
        OG004
        spread
        0.492
        value
        1.62
      6. group Id
        OG005
        spread
        0.486
        value
        1.63
      7. group Id
        OG006
        spread
        0.418
        value
        1.78
      8. group Id
        OG007
        spread
        0.314
        value
        1.36
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        34
      6. group Id
        OG005
        value
        66
      7. group Id
        OG006
        value
        10
      8. group Id
        OG007
        value
        12
      units
      Participants
    title
    total 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
    SG3199: Cycle 2
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
      4
    5. group Id
      OG004
      value
      38
    6. group Id
      OG005
      value
      69
    7. group Id
      OG006
      value
      11
    8. group Id
      OG007
      value
      12
    units
    Participants
description
AI for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199). AI is the ratio of area under the serum concentration-time curve (AUC) from 0 to 21 days for Cycle 2 divided by AUC from 0 to 21 days for Cycle 1 (Q3W schedule: 3 week cycle length; Q6W schedule: 6 week cycle length). It is the increase in drug plasma concentration after multiple dosing until a steady state is reached. 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
Accumulation Index (AI) for ADCT-402
type
SECONDARY
unit Of Measure
ratio

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

Preserved source evidence · Not medical advice