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NCT02535312 · OUTCOME

Overall Survival

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From start of treatment to time of death from any cause, assessed up to at least 3 years

What was measured

Overall survival will be summarized as time from first protocol treatment until death from any cause, using the product-limit Kaplan-Meier estimator.

Analysis population: Pre-specified in the Study Protocol to collect, analyze, and report data for this Outcome Measure by Phase and not by dose-level.

Groups in this outcome

Arm A (TRC102, Pemetrexed Disodium, Cisplatin) - Phase I

Patients receive 50, 75 or 100 mg/day of TRC102 PO QD on days 1-4, 500 mg/m\^2 of 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.

Arm B (TRC102, Pemetrexed Disodium) - Phase II

Patients receive 50 mg/day of TRC102 PO QD on days 1-4 and 500 mg/m\^2 of pemetrexed disodium IV over 10 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.

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

Analysis denominator · Participants

GroupSource count
Arm A (TRC102, Pemetrexed Disodium, Cisplatin) - Phase I16
Arm B (TRC102, Pemetrexed Disodium) - Phase II14

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A (TRC102, Pemetrexed Disodium, Cisplatin) - Phase I20.0Not reported7.9NANA - The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
Arm B (TRC102, Pemetrexed Disodium) - Phase II15.9Not reported3.4NANA - The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.15
    statistical Method
    Log Rank
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.15
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        NA - The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
        group Id
        OG000
        lower Limit
        7.9
        upper Limit
        NA
        value
        20.0
      2. comment
        NA - The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
        group Id
        OG001
        lower Limit
        3.4
        upper Limit
        NA
        value
        15.9
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    2. group Id
      OG001
      value
      14
    units
    Participants
description
Overall survival will be summarized as time from first protocol treatment until death from any cause, using the product-limit Kaplan-Meier estimator.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive 50, 75 or 100 mg/day of TRC102 PO QD on days 1-4, 500 mg/m\^2 of 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.
    id
    OG000
    title
    Arm A (TRC102, Pemetrexed Disodium, Cisplatin) - Phase I
  2. description
    Patients receive 50 mg/day of TRC102 PO QD on days 1-4 and 500 mg/m\^2 of pemetrexed disodium IV over 10 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.
    id
    OG001
    title
    Arm B (TRC102, Pemetrexed Disodium) - Phase II
param Type
MEDIAN
population Description
Pre-specified in the Study Protocol to collect, analyze, and report data for this Outcome Measure by Phase and not by dose-level.
reporting Status
POSTED
time Frame
From start of treatment to time of death from any cause, assessed up to at least 3 years
title
Overall Survival
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice