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NCT02535312 · OUTCOME

Number of Participants With at Least One Dose Limiting Toxicity (DLT) - Phase I

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
During the first cycle of treatment, up to 21 days

What was measured

Dose-limiting toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Pre-specified DLT criteria included the following adverse events (AE), judged to be at least possibly related to study therapy: grade 3 or greater non-hematologic toxicity, grade 3 thrombocytopenia with bleeding, any grade 4 thrombocytopenia, grade 4 febrile neutropenia lasting \> 7 day, any grade febrile neutropenia, any grade 5 toxicity. Treatment delay of cycle 2 by more than 2 weeks and inability to administer 3 of the 4 doses due to toxicity in the first treatment course were also considered DLTs. Controllable nausea, vomiting and diarrhea, electrolyte toxicities correctable (to baseline or grade 1) with repletion and grade 3 creatinine elevation correctable (to grade 1 or less) with IV hydration were not considered DLT's.

Groups in this outcome

Arm A, Dose Level 1 - 50mg TRC102, 60mg/m^2 Cisplatin (Phase I)

TRC102 50 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1

Arm A, Dose Level 2 - 75mg TRC102, 60mg/m^2 Cisplatin (Phase I)

TRC102 75 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1

Arm A, Dose Level 3 - 100mg TRC102, 60mg/m^2 Cisplatin (Phase I)

TRC102 100/day mg PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1

Arm A, Dose Level 4 - 100mg TRC102, 75mg/m^2 Cisplatin (Phase I)

TRC102 100/day mg PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 75 mg/m\^2 IV over 30-60 min day1

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, Dose Level 1 - 50mg TRC102, 60mg/m^2 Cisplatin (Phase I)3
Arm A, Dose Level 2 - 75mg TRC102, 60mg/m^2 Cisplatin (Phase I)4
Arm A, Dose Level 3 - 100mg TRC102, 60mg/m^2 Cisplatin (Phase I)3
Arm A, Dose Level 4 - 100mg TRC102, 75mg/m^2 Cisplatin (Phase I)6

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A, Dose Level 1 - 50mg TRC102, 60mg/m^2 Cisplatin (Phase I)0Not reportedNot reportedNot reportedNot reported
Arm A, Dose Level 2 - 75mg TRC102, 60mg/m^2 Cisplatin (Phase I)0Not reportedNot reportedNot reportedNot reported
Arm A, Dose Level 3 - 100mg TRC102, 60mg/m^2 Cisplatin (Phase I)0Not reportedNot reportedNot reportedNot reported
Arm A, Dose Level 4 - 100mg TRC102, 75mg/m^2 Cisplatin (Phase I)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      6
    units
    Participants
description
Dose-limiting toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Pre-specified DLT criteria included the following adverse events (AE), judged to be at least possibly related to study therapy: grade 3 or greater non-hematologic toxicity, grade 3 thrombocytopenia with bleeding, any grade 4 thrombocytopenia, grade 4 febrile neutropenia lasting \> 7 day, any grade febrile neutropenia, any grade 5 toxicity. Treatment delay of cycle 2 by more than 2 weeks and inability to administer 3 of the 4 doses due to toxicity in the first treatment course were also considered DLTs. Controllable nausea, vomiting and diarrhea, electrolyte toxicities correctable (to baseline or grade 1) with repletion and grade 3 creatinine elevation correctable (to grade 1 or less) with IV hydration were not considered DLT's.
groups
  1. description
    TRC102 50 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
    id
    OG000
    title
    Arm A, Dose Level 1 - 50mg TRC102, 60mg/m^2 Cisplatin (Phase I)
  2. description
    TRC102 75 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
    id
    OG001
    title
    Arm A, Dose Level 2 - 75mg TRC102, 60mg/m^2 Cisplatin (Phase I)
  3. description
    TRC102 100/day mg PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
    id
    OG002
    title
    Arm A, Dose Level 3 - 100mg TRC102, 60mg/m^2 Cisplatin (Phase I)
  4. description
    TRC102 100/day mg PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 75 mg/m\^2 IV over 30-60 min day1
    id
    OG003
    title
    Arm A, Dose Level 4 - 100mg TRC102, 75mg/m^2 Cisplatin (Phase I)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
During the first cycle of treatment, up to 21 days
title
Number of Participants With at Least One Dose Limiting Toxicity (DLT) - Phase I
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice