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NCT04844073 · OUTCOME

Cmax: Maximum Observed Plasma Concentration of TAK-186

A Study of TAK-186 (Also Known as MVC-101) in Adults With Advanced or Metastatic Cancer · Source last updated 2026-09-24

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

Measure
GEOMETRIC_MEAN
Unit
nanogram per milliliter (ng/mL)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1: Post-dose on Days 1, 8 and 15; Cycle 2: Post-dose Day 1 (Each cycle is 56 days)

What was measured

Cmax of TAK-186 was reported. As prespecified in the analysis plan, all participants in this combined cohort received the same target dose level of TAK-186. Therefore, data from these participants were pooled and analyzed as a single cohort.

Analysis population: Pharmacokinetic (PK) population included all participants who received at least 1 dose of TAK-186 and sufficient PK data to reliably estimate 1 or more PK parameters. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure and "number analysed" signifies participants at the specific categories.

Groups in this outcome

Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone

Participants received TAK-186, Dose A as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose A is the lowest dose.

Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone

Participants received TAK-186, Dose B as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose B is higher than Dose A.

Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone

Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose C is higher than Dose B.

Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone

Participants received TAK-186, Dose B on Day 1 followed by Dose D on Day 8 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose D is higher than Dose B.

Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone

Participants in Dose Escalation Phase and Cohort Expansion Phase received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose E on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion and post-infusion. Dose E is higher than Dose C and B.

Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone

Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose F on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose F is highest dose and is higher than Dose B and C.

Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone

Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose D on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone premedication was administered pre-infusion and post-infusion. Dose D is higher than Dose B and C.

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 Phase: TAK-186 - Dose A + Dexamethasone1
Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone1
Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone5
Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone10
Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone61
Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone5
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone12

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone1
Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone1
Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone5
Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone10
Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone61
Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone5
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone12
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone1.01NANot reportedNot reportedThe geometric coefficient of variation was not estimable for a single participant.
Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone3.29NANot reportedNot reportedThe geometric coefficient of variation was not estimable for a single participant.
Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone6.1793.1Not reportedNot reportedNot reported
Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone4.1223.1Not reportedNot reportedNot reported
Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone4.7690.8Not reportedNot reportedNot reported
Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone4.1250.5Not reportedNot reportedNot reported
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone6.06114Not reportedNot reportedNot reported
Cycle 1 Day 8

Analysis denominator · Participants

GroupSource count
Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone0
Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone0
Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone4
Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone9
Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone58
Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone4
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone11
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone14.575.3Not reportedNot reportedNot reported
Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone28.521.3Not reportedNot reportedNot reported
Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone13.891.9Not reportedNot reportedNot reported
Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone11.832.3Not reportedNot reportedNot reported
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone13.874.3Not reportedNot reportedNot reported
Cycle 1 Day 15

Analysis denominator · Participants

GroupSource count
Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone0
Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone0
Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone0
Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone0
Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone56
Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone4
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone10
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone38.586.5Not reportedNot reportedNot reported
Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone78.940.2Not reportedNot reportedNot reported
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone24.954.0Not reportedNot reportedNot reported
Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone1
Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone0
Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone3
Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone5
Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone21
Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone2
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone3
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone5.66NANot reportedNot reportedThe geometric coefficient of variation was not estimable for a single participant.
Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone24.954.6Not reportedNot reportedNot reported
Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone44.7340Not reportedNot reportedNot reported
Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone67.078.0Not reportedNot reportedNot reported
Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone11418.8Not reportedNot reportedNot reported
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone32.757.3Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The geometric coefficient of variation was not estimable for a single participant.
        group Id
        OG000
        spread
        NA
        value
        1.01
      2. comment
        The geometric coefficient of variation was not estimable for a single participant.
        group Id
        OG001
        spread
        NA
        value
        3.29
      3. group Id
        OG002
        spread
        93.1
        value
        6.17
      4. group Id
        OG003
        spread
        23.1
        value
        4.12
      5. group Id
        OG004
        spread
        90.8
        value
        4.76
      6. group Id
        OG005
        spread
        50.5
        value
        4.12
      7. group Id
        OG006
        spread
        114
        value
        6.06
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        10
      5. group Id
        OG004
        value
        61
      6. group Id
        OG005
        value
        5
      7. group Id
        OG006
        value
        12
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG002
        spread
        75.3
        value
        14.5
      2. group Id
        OG003
        spread
        21.3
        value
        28.5
      3. group Id
        OG004
        spread
        91.9
        value
        13.8
      4. group Id
        OG005
        spread
        32.3
        value
        11.8
      5. group Id
        OG006
        spread
        74.3
        value
        13.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        9
      5. group Id
        OG004
        value
        58
      6. group Id
        OG005
        value
        4
      7. group Id
        OG006
        value
        11
      units
      Participants
    title
    Cycle 1 Day 8
  3. categories
    1. measurements
      1. group Id
        OG004
        spread
        86.5
        value
        38.5
      2. group Id
        OG005
        spread
        40.2
        value
        78.9
      3. group Id
        OG006
        spread
        54.0
        value
        24.9
    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
        56
      6. group Id
        OG005
        value
        4
      7. group Id
        OG006
        value
        10
      units
      Participants
    title
    Cycle 1 Day 15
  4. categories
    1. measurements
      1. comment
        The geometric coefficient of variation was not estimable for a single participant.
        group Id
        OG000
        spread
        NA
        value
        5.66
      2. group Id
        OG002
        spread
        54.6
        value
        24.9
      3. group Id
        OG003
        spread
        340
        value
        44.7
      4. group Id
        OG004
        spread
        78.0
        value
        67.0
      5. group Id
        OG005
        spread
        18.8
        value
        114
      6. group Id
        OG006
        spread
        57.3
        value
        32.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        5
      5. group Id
        OG004
        value
        21
      6. group Id
        OG005
        value
        2
      7. group Id
        OG006
        value
        3
      units
      Participants
    title
    Cycle 2 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      10
    5. group Id
      OG004
      value
      61
    6. group Id
      OG005
      value
      5
    7. group Id
      OG006
      value
      12
    units
    Participants
description
Cmax of TAK-186 was reported. As prespecified in the analysis plan, all participants in this combined cohort received the same target dose level of TAK-186. Therefore, data from these participants were pooled and analyzed as a single cohort.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received TAK-186, Dose A as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose A is the lowest dose.
    id
    OG000
    title
    Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone
  2. description
    Participants received TAK-186, Dose B as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose B is higher than Dose A.
    id
    OG001
    title
    Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone
  3. description
    Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose C is higher than Dose B.
    id
    OG002
    title
    Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone
  4. description
    Participants received TAK-186, Dose B on Day 1 followed by Dose D on Day 8 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose D is higher than Dose B.
    id
    OG003
    title
    Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone
  5. description
    Participants in Dose Escalation Phase and Cohort Expansion Phase received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose E on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion and post-infusion. Dose E is higher than Dose C and B.
    id
    OG004
    title
    Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone
  6. description
    Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose F on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose F is highest dose and is higher than Dose B and C.
    id
    OG005
    title
    Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone
  7. description
    Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose D on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone premedication was administered pre-infusion and post-infusion. Dose D is higher than Dose B and C.
    id
    OG006
    title
    Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone
param Type
GEOMETRIC_MEAN
population Description
Pharmacokinetic (PK) population included all participants who received at least 1 dose of TAK-186 and sufficient PK data to reliably estimate 1 or more PK parameters. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure and "number analysed" signifies participants at the specific categories.
reporting Status
POSTED
time Frame
Cycle 1: Post-dose on Days 1, 8 and 15; Cycle 2: Post-dose Day 1 (Each cycle is 56 days)
title
Cmax: Maximum Observed Plasma Concentration of TAK-186
type
SECONDARY
unit Of Measure
nanogram per milliliter (ng/mL)

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Preserved source evidence · Not medical advice