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NCT02535312 · OUTCOME

Maximum Tolerated Dose (MTD)

Methoxyamine, Cisplatin, and Pemetrexed Disodium in Treating Patients With Advanced Solid Tumors or Mesothelioma That Cannot Be Removed by Surgery or Mesothelioma That Is Refractory to Pemetrexed Disodium and Cisplatin or Carboplatin · Source last updated 2026-07-31

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

Measure
NUMBER
Unit
mg/day
Interval / dispersion
Not reported
Time frame
21 days from start of treatment, up to 2 years

What was measured

The maximum tolerated dose of TRC102 in combination with 500mg/m\^2 IV of Pemetrex and 60 or 75 mg/m\^2 IV of Cisplatin is based on toxicities observed during the first cycle and is defined as the highest dose tested in which fewer than 33% of patients experience an attributable DLT to the study drug, when at least 6 patients are treated at that dose and are evaluable for toxicity. Dose escalations proceeded according to a standard 3+3 design.

Groups in this outcome

Treatment (TRC102, Pemetrexed Disodium, Cisplatin)

Patients receive starting dose of TRC102 50 mg/day PO on days 1-4, 500 mg/m\^2 pemetrexed disodium IV over 10 minutes, and 60 or 75 mg/m\^2 of cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue TRC102 and pemetrexed disodium beyond cycle 6 if the patient continues to benefit from treatment at the discretion of the treating physician. Cisplatin: Given IV TRC102: Given PO Pemetrexed Disodium: Given IV

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

Analysis denominator · Participants

GroupSource count
Treatment (TRC102, Pemetrexed Disodium, Cisplatin)16

Reported measurements

Source class 1
Values in mg/day · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (TRC102, Pemetrexed Disodium, Cisplatin)100Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        100
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    units
    Participants
description
The maximum tolerated dose of TRC102 in combination with 500mg/m\^2 IV of Pemetrex and 60 or 75 mg/m\^2 IV of Cisplatin is based on toxicities observed during the first cycle and is defined as the highest dose tested in which fewer than 33% of patients experience an attributable DLT to the study drug, when at least 6 patients are treated at that dose and are evaluable for toxicity. Dose escalations proceeded according to a standard 3+3 design.
groups
  1. description
    Patients receive starting dose of TRC102 50 mg/day PO on days 1-4, 500 mg/m\^2 pemetrexed disodium IV over 10 minutes, and 60 or 75 mg/m\^2 of cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue TRC102 and pemetrexed disodium beyond cycle 6 if the patient continues to benefit from treatment at the discretion of the treating physician. Cisplatin: Given IV TRC102: Given PO Pemetrexed Disodium: Given IV
    id
    OG000
    title
    Treatment (TRC102, Pemetrexed Disodium, Cisplatin)
param Type
NUMBER
reporting Status
POSTED
time Frame
21 days from start of treatment, up to 2 years
title
Maximum Tolerated Dose (MTD)
type
PRIMARY
unit Of Measure
mg/day

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

Preserved source evidence · Not medical advice