Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02669017 · OUTCOME

Time to Reach the Maximum Serum Concentration (Tmax) 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
MEDIAN
Unit
days
Interval / dispersion
Full Range
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

Tmax 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 Q3W4
Part 1: 90 μg/kg Q3W5
Parts 1 and 2: 120 μg/kg Q3W42
Parts 1 and 2: 150 μg/kg Q3W88
Part 1: 200 μg/kg Q3W14
Part 1: 200 μg/kg Q6W22

Reported measurements

PBD conjugated Ab: Cycle 1

Analysis denominator · Participants

GroupSource count
Part 1: 15 μg/kg Q3W4
Part 1: 30 μg/kg Q3W4
Part 1: 60 μg/kg Q3W4
Part 1: 90 μg/kg Q3W5
Parts 1 and 2: 120 μg/kg Q3W42
Parts 1 and 2: 150 μg/kg Q3W88
Part 1: 200 μg/kg Q3W14
Part 1: 200 μg/kg Q6W22
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1: 15 μg/kg Q3W0.0837Not reported0.08330.0854Not reported
Part 1: 30 μg/kg Q3W0.0833Not reported0.04310.319Not reported
Part 1: 60 μg/kg Q3W0.0819Not reported0.04170.0847Not reported
Part 1: 90 μg/kg Q3W0.0500Not reported0.04170.0875Not reported
Parts 1 and 2: 120 μg/kg Q3W0.0833Not reported0.04030.296Not reported
Parts 1 and 2: 150 μg/kg Q3W0.0840Not reported0.04170.305Not reported
Part 1: 200 μg/kg Q3W0.0858Not reported0.04170.285Not reported
Part 1: 200 μg/kg Q6W0.0840Not reported0.04170.276Not 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 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
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1: 15 μg/kg Q3W0.122Not reported0.06600.170Not reported
Part 1: 30 μg/kg Q3W0.0618Not reported0.04170.0875Not reported
Part 1: 60 μg/kg Q3W0.0417Not reported0.02220.165Not reported
Part 1: 90 μg/kg Q3W0.0833Not reported0.02290.0882Not reported
Parts 1 and 2: 120 μg/kg Q3W0.0830Not reported0.02080.278Not reported
Parts 1 and 2: 150 μg/kg Q3W0.0642Not reported0.02081.00Not reported
Part 1: 200 μg/kg Q3W0.0854Not reported0.02081.00Not reported
Part 1: 200 μg/kg Q6W0.0826Not reported0.02570.172Not reported
total Ab: Cycle 1

Analysis denominator · Participants

GroupSource count
Part 1: 15 μg/kg Q3W4
Part 1: 30 μg/kg Q3W4
Part 1: 60 μg/kg Q3W4
Part 1: 90 μg/kg Q3W5
Parts 1 and 2: 120 μg/kg Q3W41
Parts 1 and 2: 150 μg/kg Q3W88
Part 1: 200 μg/kg Q3W14
Part 1: 200 μg/kg Q6W22
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1: 15 μg/kg Q3W0.0844Not reported0.04380.292Not reported
Part 1: 30 μg/kg Q3W0.0833Not reported0.04310.0896Not reported
Part 1: 60 μg/kg Q3W0.0833Not reported0.08060.0847Not reported
Part 1: 90 μg/kg Q3W0.0500Not reported0.04170.169Not reported
Parts 1 and 2: 120 μg/kg Q3W0.0833Not reported0.04030.294Not reported
Parts 1 and 2: 150 μg/kg Q3W0.0837Not reported0.04030.299Not reported
Part 1: 200 μg/kg Q3W0.0840Not reported0.04170.285Not reported
Part 1: 200 μg/kg Q6W0.0837Not reported0.04170.271Not 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 Q3W5
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 days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1: 15 μg/kg Q3W0.0649Not reported0.04310.0868Not reported
Part 1: 30 μg/kg Q3W0.0618Not reported0.04170.0875Not reported
Part 1: 60 μg/kg Q3W0.0417Not reported0.02220.0854Not reported
Part 1: 90 μg/kg Q3W0.0833Not reported0.02290.159Not reported
Parts 1 and 2: 120 μg/kg Q3W0.0632Not reported0.02080.275Not reported
Parts 1 and 2: 150 μg/kg Q3W0.0639Not reported02.11Not reported
Part 1: 200 μg/kg Q3W0.132Not reported0.02084.00Not reported
Part 1: 200 μg/kg Q6W0.0858Not reported0.02570.172Not 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 Q3W1
Parts 1 and 2: 120 μg/kg Q3W4
Parts 1 and 2: 150 μg/kg Q3W28
Part 1: 200 μg/kg Q3W4
Part 1: 200 μg/kg Q6W16
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1: 90 μg/kg Q3W0.0833Not reported0.08330.0833Not reported
Parts 1 and 2: 120 μg/kg Q3W0.0854Not reported0.04580.172Not reported
Parts 1 and 2: 150 μg/kg Q3W0.0844Not reported0.04170.294Not reported
Part 1: 200 μg/kg Q3W0.128Not reported0.08330.285Not reported
Part 1: 200 μg/kg Q6W0.165Not reported0.04176.81Not 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 Q3W2
Parts 1 and 2: 120 μg/kg Q3W4
Parts 1 and 2: 150 μg/kg Q3W15
Part 1: 200 μg/kg Q3W3
Part 1: 200 μg/kg Q6W4
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1: 90 μg/kg Q3W1.05Not reported0.04172.06Not reported
Parts 1 and 2: 120 μg/kg Q3W0.120Not reported0.08400.153Not reported
Parts 1 and 2: 150 μg/kg Q3W0.0632Not reported0.022213.8Not reported
Part 1: 200 μg/kg Q3W0.165Not reported0.02990.992Not reported
Part 1: 200 μg/kg Q6W0.162Not reported0.08330.280Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0833
        upper Limit
        0.0854
        value
        0.0837
      2. group Id
        OG001
        lower Limit
        0.0431
        upper Limit
        0.319
        value
        0.0833
      3. group Id
        OG002
        lower Limit
        0.0417
        upper Limit
        0.0847
        value
        0.0819
      4. group Id
        OG003
        lower Limit
        0.0417
        upper Limit
        0.0875
        value
        0.0500
      5. group Id
        OG004
        lower Limit
        0.0403
        upper Limit
        0.296
        value
        0.0833
      6. group Id
        OG005
        lower Limit
        0.0417
        upper Limit
        0.305
        value
        0.0840
      7. group Id
        OG006
        lower Limit
        0.0417
        upper Limit
        0.285
        value
        0.0858
      8. group Id
        OG007
        lower Limit
        0.0417
        upper Limit
        0.276
        value
        0.0840
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        5
      5. group Id
        OG004
        value
        42
      6. group Id
        OG005
        value
        88
      7. group Id
        OG006
        value
        14
      8. group Id
        OG007
        value
        22
      units
      Participants
    title
    PBD conjugated Ab: Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0660
        upper Limit
        0.170
        value
        0.122
      2. group Id
        OG001
        lower Limit
        0.0417
        upper Limit
        0.0875
        value
        0.0618
      3. group Id
        OG002
        lower Limit
        0.0222
        upper Limit
        0.165
        value
        0.0417
      4. group Id
        OG003
        lower Limit
        0.0229
        upper Limit
        0.0882
        value
        0.0833
      5. group Id
        OG004
        lower Limit
        0.0208
        upper Limit
        0.278
        value
        0.0830
      6. group Id
        OG005
        lower Limit
        0.0208
        upper Limit
        1.00
        value
        0.0642
      7. group Id
        OG006
        lower Limit
        0.0208
        upper Limit
        1.00
        value
        0.0854
      8. group Id
        OG007
        lower Limit
        0.0257
        upper Limit
        0.172
        value
        0.0826
    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
    title
    PBD conjugated Ab: Cycle 2
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0438
        upper Limit
        0.292
        value
        0.0844
      2. group Id
        OG001
        lower Limit
        0.0431
        upper Limit
        0.0896
        value
        0.0833
      3. group Id
        OG002
        lower Limit
        0.0806
        upper Limit
        0.0847
        value
        0.0833
      4. group Id
        OG003
        lower Limit
        0.0417
        upper Limit
        0.169
        value
        0.0500
      5. group Id
        OG004
        lower Limit
        0.0403
        upper Limit
        0.294
        value
        0.0833
      6. group Id
        OG005
        lower Limit
        0.0403
        upper Limit
        0.299
        value
        0.0837
      7. group Id
        OG006
        lower Limit
        0.0417
        upper Limit
        0.285
        value
        0.0840
      8. group Id
        OG007
        lower Limit
        0.0417
        upper Limit
        0.271
        value
        0.0837
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        5
      5. group Id
        OG004
        value
        41
      6. group Id
        OG005
        value
        88
      7. group Id
        OG006
        value
        14
      8. group Id
        OG007
        value
        22
      units
      Participants
    title
    total Ab: Cycle 1
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0431
        upper Limit
        0.0868
        value
        0.0649
      2. group Id
        OG001
        lower Limit
        0.0417
        upper Limit
        0.0875
        value
        0.0618
      3. group Id
        OG002
        lower Limit
        0.0222
        upper Limit
        0.0854
        value
        0.0417
      4. group Id
        OG003
        lower Limit
        0.0229
        upper Limit
        0.159
        value
        0.0833
      5. group Id
        OG004
        lower Limit
        0.0208
        upper Limit
        0.275
        value
        0.0632
      6. group Id
        OG005
        lower Limit
        0
        upper Limit
        2.11
        value
        0.0639
      7. group Id
        OG006
        lower Limit
        0.0208
        upper Limit
        4.00
        value
        0.132
      8. group Id
        OG007
        lower Limit
        0.0257
        upper Limit
        0.172
        value
        0.0858
    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
        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. group Id
        OG003
        lower Limit
        0.0833
        upper Limit
        0.0833
        value
        0.0833
      2. group Id
        OG004
        lower Limit
        0.0458
        upper Limit
        0.172
        value
        0.0854
      3. group Id
        OG005
        lower Limit
        0.0417
        upper Limit
        0.294
        value
        0.0844
      4. group Id
        OG006
        lower Limit
        0.0833
        upper Limit
        0.285
        value
        0.128
      5. group Id
        OG007
        lower Limit
        0.0417
        upper Limit
        6.81
        value
        0.165
    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
        1
      5. group Id
        OG004
        value
        4
      6. group Id
        OG005
        value
        28
      7. group Id
        OG006
        value
        4
      8. group Id
        OG007
        value
        16
      units
      Participants
    title
    SG3199: Cycle 1
  6. categories
    1. measurements
      1. group Id
        OG003
        lower Limit
        0.0417
        upper Limit
        2.06
        value
        1.05
      2. group Id
        OG004
        lower Limit
        0.0840
        upper Limit
        0.153
        value
        0.120
      3. group Id
        OG005
        lower Limit
        0.0222
        upper Limit
        13.8
        value
        0.0632
      4. group Id
        OG006
        lower Limit
        0.0299
        upper Limit
        0.992
        value
        0.165
      5. group Id
        OG007
        lower Limit
        0.0833
        upper Limit
        0.280
        value
        0.162
    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
        2
      5. group Id
        OG004
        value
        4
      6. group Id
        OG005
        value
        15
      7. group Id
        OG006
        value
        3
      8. group Id
        OG007
        value
        4
      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
      4
    4. group Id
      OG003
      value
      5
    5. group Id
      OG004
      value
      42
    6. group Id
      OG005
      value
      88
    7. group Id
      OG006
      value
      14
    8. group Id
      OG007
      value
      22
    units
    Participants
description
Tmax 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
Full Range
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
MEDIAN
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
Time to Reach the Maximum Serum Concentration (Tmax) for ADCT-402
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice