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NCT03480750 · OUTCOME

Maximum Tolerated Dose, MTD

Trial of Trientine Plus Pegylated Liposomal Doxorubicin and Carboplatin in Epithelial Ovarian Cancer · Source last updated 2020-11-10

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

Measure
NUMBER
Unit
mg
Interval / dispersion
Not reported
Time frame
within 36 days after the start of Trientine

What was measured

'3+3' study design. MTD will be defined at the dose level of trientine prior to the level with DLT events ≧ 2/6 participants.

Analysis population: One participant receiving 600 mg/day declined the trial drugs and did not proceed with treatment.Therefore, an additional participant was included at the same dose level.

Groups in this outcome

Trientine With Chemotherapy Dose Level 1 - 6 (300 -1800mg)

trientine dihydrochloride: trientine dihydrochloride 300 - 1800MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1

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

Analysis denominator · Participants

GroupSource count
Trientine With Chemotherapy Dose Level 1 - 6 (300 -1800mg)17

Reported measurements

Source class 1
Values in mg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trientine With Chemotherapy Dose Level 1 - 6 (300 -1800mg)NANot reportedNot reportedNot reportedNo DLTs or treatment-related deaths were reported, which may be due to insufficient number of participants with events to determine MTD.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        No DLTs or treatment-related deaths were reported, which may be due to insufficient number of participants with events to determine MTD.
        group Id
        OG000
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    units
    Participants
description
'3+3' study design. MTD will be defined at the dose level of trientine prior to the level with DLT events ≧ 2/6 participants.
groups
  1. description
    trientine dihydrochloride: trientine dihydrochloride 300 - 1800MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
    id
    OG000
    title
    Trientine With Chemotherapy Dose Level 1 - 6 (300 -1800mg)
param Type
NUMBER
population Description
One participant receiving 600 mg/day declined the trial drugs and did not proceed with treatment.Therefore, an additional participant was included at the same dose level.
reporting Status
POSTED
time Frame
within 36 days after the start of Trientine
title
Maximum Tolerated Dose, MTD
type
SECONDARY
unit Of Measure
mg

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

Preserved source evidence · Not medical advice