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NCT04434469 · OUTCOME

Minimum Concentration Observed (Cmin) of RO7297089

A Study Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma · Source last updated 2024-07-03

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

Measure
GEOMETRIC_MEAN
Unit
ug/mL
Interval / dispersion
Standard Deviation
Time frame
Cycle 1 Day 1, Cycle 2 Day 8

Analysis population: Only those participants who received full dose were included in the results summary

Groups in this outcome

Dose Escalation Cohort 1: RO7297089

Participants in Arm A received 60 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit

Dose Escalation Cohort 2: RO7297089

Participants in Arm A received 180 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit

Dose Escalation Cohort 3: RO7297089

Participants in Arm A received 360 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit

Dose Escalation Cohort 4: RO7297089

Participants in Arm A received 1080 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit

Dose Escalation Backfill Cohort 4: RO7297089

Participants in Arm B received the 1080 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose wasadministered at subsequent study drug administration visits.

Dose Escalation Cohort 5: RO7297089

Participants in Arm B received the 1850 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose was administered at subsequent study drug administration visits.

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 Escalation Cohort 1: RO72970893
Dose Escalation Cohort 2: RO72970894
Dose Escalation Cohort 3: RO72970893
Dose Escalation Cohort 4: RO72970891
Dose Escalation Backfill Cohort 4: RO72970894
Dose Escalation Cohort 5: RO72970893

Reported measurements

C1D1

Analysis denominator · Participants

GroupSource count
Dose Escalation Cohort 1: RO72970893
Dose Escalation Cohort 2: RO72970894
Dose Escalation Cohort 3: RO72970893
Dose Escalation Cohort 4: RO72970891
Dose Escalation Backfill Cohort 4: RO72970894
Dose Escalation Cohort 5: RO72970893
Values in ug/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Escalation Cohort 1: RO72970890.1922.3Not reportedNot reportedNot reported
Dose Escalation Cohort 2: RO72970890.9642.5Not reportedNot reportedNot reported
Dose Escalation Cohort 3: RO72970899.19500Not reportedNot reportedNot reported
Dose Escalation Cohort 4: RO7297089140NANot reportedNot reportedOnly 1 participant analyzed
Dose Escalation Backfill Cohort 4: RO729708981.385.1Not reportedNot reportedNot reported
Dose Escalation Cohort 5: RO729708919732.6Not reportedNot reportedNot reported
C2D8

Analysis denominator · Participants

GroupSource count
Dose Escalation Cohort 1: RO72970893
Dose Escalation Cohort 2: RO72970891
Dose Escalation Cohort 3: RO72970893
Dose Escalation Cohort 4: RO72970891
Dose Escalation Backfill Cohort 4: RO72970894
Dose Escalation Cohort 5: RO72970893
Values in ug/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dose Escalation Cohort 1: RO72970890.2539.9Not reportedNot reportedNot reported
Dose Escalation Cohort 2: RO72970892.99NANot reportedNot reportedOnly 1 participant analyzed
Dose Escalation Cohort 3: RO729708919.7372Not reportedNot reportedNot reported
Dose Escalation Cohort 4: RO7297089163NANot reportedNot reportedOnly 1 participant analyzed
Dose Escalation Backfill Cohort 4: RO729708920790.0Not reportedNot reportedNot reported
Dose Escalation Cohort 5: RO729708945040.2Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.3
        value
        0.19
      2. group Id
        OG001
        spread
        42.5
        value
        0.96
      3. group Id
        OG002
        spread
        500
        value
        9.19
      4. comment
        Only 1 participant analyzed
        group Id
        OG003
        spread
        NA
        value
        140
      5. group Id
        OG004
        spread
        85.1
        value
        81.3
      6. group Id
        OG005
        spread
        32.6
        value
        197
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        4
      6. group Id
        OG005
        value
        3
      units
      Participants
    title
    C1D1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        39.9
        value
        0.25
      2. comment
        Only 1 participant analyzed
        group Id
        OG001
        spread
        NA
        value
        2.99
      3. group Id
        OG002
        spread
        372
        value
        19.7
      4. comment
        Only 1 participant analyzed
        group Id
        OG003
        spread
        NA
        value
        163
      5. group Id
        OG004
        spread
        90.0
        value
        207
      6. group Id
        OG005
        spread
        40.2
        value
        450
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        4
      6. group Id
        OG005
        value
        3
      units
      Participants
    title
    C2D8
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      1
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      3
    units
    Participants
dispersion Type
Standard Deviation
groups
  1. description
    Participants in Arm A received 60 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
    id
    OG000
    title
    Dose Escalation Cohort 1: RO7297089
  2. description
    Participants in Arm A received 180 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
    id
    OG001
    title
    Dose Escalation Cohort 2: RO7297089
  3. description
    Participants in Arm A received 360 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
    id
    OG002
    title
    Dose Escalation Cohort 3: RO7297089
  4. description
    Participants in Arm A received 1080 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit
    id
    OG003
    title
    Dose Escalation Cohort 4: RO7297089
  5. description
    Participants in Arm B received the 1080 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose wasadministered at subsequent study drug administration visits.
    id
    OG004
    title
    Dose Escalation Backfill Cohort 4: RO7297089
  6. description
    Participants in Arm B received the 1850 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose was administered at subsequent study drug administration visits.
    id
    OG005
    title
    Dose Escalation Cohort 5: RO7297089
param Type
GEOMETRIC_MEAN
population Description
Only those participants who received full dose were included in the results summary
reporting Status
POSTED
time Frame
Cycle 1 Day 1, Cycle 2 Day 8
title
Minimum Concentration Observed (Cmin) of RO7297089
type
SECONDARY
unit Of Measure
ug/mL

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

Preserved source evidence · Not medical advice