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NCT01326702 · OUTCOME

Pharmacokinetic Parameters of Veliparib (Phase Ib)

Veliparib, Bendamustine Hydrochloride, and Rituximab in Treating Patients With Relapsed or Refractory Lymphoma, Multiple Myeloma, or Solid Tumors · Source last updated 2019-12-16

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

Measure
GEOMETRIC_MEAN
Unit
μg*h/mL
Interval / dispersion
Standard Deviation
Time frame
From time zero to 12 hours on day 2 of course 1

What was measured

Area Under the Curve from time zero to 12 hours following Veliparib administration

Groups in this outcome

Dose Level 1-Bendamustine 70 mg/m2, ABT-888 50 mg

Bendamustine 70 mg/m2, ABT-888 50 mg

Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg

Bendamustine 90 mg/m2, ABT-888 50 mg

Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID

Bendamustine 90 mg/m2, ABT-888 100 mg BID

Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID

Bendamustine 90 mg/m2, ABT-888 150 mg BID

Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID

Bendamustine 90 mg/m2, ABT-888 200 mg BID

Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID

Bendamustine 90 mg/m2, ABT-888 300 mg BID

Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID

Bendamustine 90 mg/m2, ABT-888 400 mg BID

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

Analysis denominator · Participants

GroupSource count
Dose Level 1-Bendamustine 70 mg/m2, ABT-888 50 mg3
Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg2
Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID6
Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID3
Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID5
Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID6
Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID7

Reported measurements

Source class 1
Values in μg*h/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Level 1-Bendamustine 70 mg/m2, ABT-888 50 mg1.790.41Not reportedNot reportedNot reported
Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg3.580.93Not reportedNot reportedNot reported
Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID7.931.90Not reportedNot reportedNot reported
Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID12.63.8Not reportedNot reportedNot reported
Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID16.911.1Not reportedNot reportedNot reported
Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID19.010.5Not reportedNot reportedNot reported
Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID25.014.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.41
        value
        1.79
      2. group Id
        OG001
        spread
        0.93
        value
        3.58
      3. group Id
        OG002
        spread
        1.90
        value
        7.93
      4. group Id
        OG003
        spread
        3.8
        value
        12.6
      5. group Id
        OG004
        spread
        11.1
        value
        16.9
      6. group Id
        OG005
        spread
        10.5
        value
        19.0
      7. group Id
        OG006
        spread
        14.6
        value
        25.0
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      5
    6. group Id
      OG005
      value
      6
    7. group Id
      OG006
      value
      7
    units
    Participants
description
Area Under the Curve from time zero to 12 hours following Veliparib administration
dispersion Type
Standard Deviation
groups
  1. description
    Bendamustine 70 mg/m2, ABT-888 50 mg
    id
    OG000
    title
    Dose Level 1-Bendamustine 70 mg/m2, ABT-888 50 mg
  2. description
    Bendamustine 90 mg/m2, ABT-888 50 mg
    id
    OG001
    title
    Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg
  3. description
    Bendamustine 90 mg/m2, ABT-888 100 mg BID
    id
    OG002
    title
    Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID
  4. description
    Bendamustine 90 mg/m2, ABT-888 150 mg BID
    id
    OG003
    title
    Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID
  5. description
    Bendamustine 90 mg/m2, ABT-888 200 mg BID
    id
    OG004
    title
    Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID
  6. description
    Bendamustine 90 mg/m2, ABT-888 300 mg BID
    id
    OG005
    title
    Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID
  7. description
    Bendamustine 90 mg/m2, ABT-888 400 mg BID
    id
    OG006
    title
    Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID
param Type
GEOMETRIC_MEAN
reporting Status
POSTED
time Frame
From time zero to 12 hours on day 2 of course 1
title
Pharmacokinetic Parameters of Veliparib (Phase Ib)
type
SECONDARY
unit Of Measure
μg*h/mL

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Preserved source evidence · Not medical advice