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NCT04844073 · OUTCOME

AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for 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
h*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

AUClast 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: PK population. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure \& "number analyzed" signifies participants at the specific categories. TAK-186 was administered QW and had a lead-in dosing (LiD) regimen including 1-step and 2-step lead-in. Analysis at the lead-in dose time points was not possible due to insufficient data points.

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 + 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 + 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

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 + 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 + Dexamethasone0
Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone0
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone0
Values in h*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone5.54NANot reportedNot reportedThe geometric coefficient of variation was not estimable as a single participant was analyzed.
Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone16.1NANot reportedNot reportedThe geometric coefficient of variation was not estimable as a single participant was analyzed.
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 + Dexamethasone0
Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone0
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone0
Values in h*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone96.9117Not reportedNot reportedNot reported
Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone31416.2Not 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 h*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone559105Not reportedNot reportedNot reported
Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone76636.1Not reportedNot reportedNot reported
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone32534.8Not 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 h*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone28.2NANot reportedNot reportedThe geometric coefficient of variation was not estimable as a single participant was analyzed.
Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone37.969.1Not reportedNot reportedNot reported
Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone312145Not reportedNot reportedNot reported
Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone584337Not reportedNot reportedNot reported
Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone149031.4Not reportedNot reportedNot reported
Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone136333Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The geometric coefficient of variation was not estimable as a single participant was analyzed.
        group Id
        OG000
        spread
        NA
        value
        5.54
      2. comment
        The geometric coefficient of variation was not estimable as a single participant was analyzed.
        group Id
        OG001
        spread
        NA
        value
        16.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      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
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG002
        spread
        117
        value
        96.9
      2. group Id
        OG003
        spread
        16.2
        value
        314
    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
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      units
      Participants
    title
    Cycle 1 Day 8
  3. categories
    1. measurements
      1. group Id
        OG004
        spread
        105
        value
        559
      2. group Id
        OG005
        spread
        36.1
        value
        766
      3. group Id
        OG006
        spread
        34.8
        value
        325
    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 as a single participant was analyzed.
        group Id
        OG000
        spread
        NA
        value
        28.2
      2. group Id
        OG002
        spread
        69.1
        value
        37.9
      3. group Id
        OG003
        spread
        145
        value
        312
      4. group Id
        OG004
        spread
        337
        value
        584
      5. group Id
        OG005
        spread
        31.4
        value
        1490
      6. group Id
        OG006
        spread
        333
        value
        136
    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
      4
    4. group Id
      OG003
      value
      9
    5. group Id
      OG004
      value
      56
    6. group Id
      OG005
      value
      4
    7. group Id
      OG006
      value
      10
    units
    Participants
description
AUClast 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
PK population. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure \& "number analyzed" signifies participants at the specific categories. TAK-186 was administered QW and had a lead-in dosing (LiD) regimen including 1-step and 2-step lead-in. Analysis at the lead-in dose time points was not possible due to insufficient data points.
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
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for TAK-186
type
SECONDARY
unit Of Measure
h*ng/mL

Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0

Preserved source evidence · Not medical advice