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NCT03233724 · OUTCOME

Number of Participants With a Dose Limiting Hematologic Toxicity (DLT)

Oral Decitabine and Tetrahydrouridine as Epigenetic Priming for Pembrolizumab-Mediated Immune Checkpoint Blockade in Patients With Inoperable, or Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancers and Esophageal Carcinomas · Source last updated 2023-05-31

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
First two cycles of Course 1 of therapy

What was measured

A DLT is any Grade 3 (severe) or greater toxicity that cannot be attributed to a cause other than study treatment during the first two cycles of Course 1 of therapy such as disease progression or intercurrent illness.

Analysis population: 1/9 participants did not receive any therapy.

Groups in this outcome

Decitabine 0.2mg/kg + Tetrahydrouridine 10mg/kg Sunday, Monday, Tuesday (SuMT)

Phase 1, Arm 1, Dose Escalation, ORIGINAL Dose Level 1: Participants received Decitabine 0.2mg/kg + Tetrahydrouridine 10mg/kg Sunday, Monday, Tuesday (SuMT) q week with Pembrolizumab infusion q3weeks

Decitabine 0.2mg/kg + Tetrahydrouridine 10mg/kg Monday-Tuesday (MT)

Phase 1, Arm 1, Dose Escalation, ORIGINAL Dose Level -1: Participants received Decitabine 0.2mg/kg + Tetrahydrouridine 10mg/kg Monday-Tuesday (MT) q week. Participants received Pembrolizumab infusion q3weeks.

Decitabine 0.2mg/kg + Tetrahydrouridine 10mg/kg Every (q) Tuesday,Wednesday (TW) x 2 Weeks q3Weeks

Phase 1, Arm 1, Dose Escalation, Revised Dose Level 1. Participants received Decitabine 0.21 mg/kg + Tetrahydrouridine 10mg/kg TW weekly x 2 weeks q 3 weeks. Participants received pembrolizumab infusion q 3weeks.

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

Analysis denominator · Participants

GroupSource count
Decitabine 0.2mg/kg + Tetrahydrouridine 10mg/kg Sunday, Monday, Tuesday (SuMT)2
Decitabine 0.2mg/kg + Tetrahydrouridine 10mg/kg Monday-Tuesday (MT)2
Decitabine 0.2mg/kg + Tetrahydrouridine 10mg/kg Every (q) Tuesday,Wednesday (TW) x 2 Weeks q3Weeks4

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Decitabine 0.2mg/kg + Tetrahydrouridine 10mg/kg Sunday, Monday, Tuesday (SuMT)2Not reportedNot reportedNot reportedNot reported
Decitabine 0.2mg/kg + Tetrahydrouridine 10mg/kg Monday-Tuesday (MT)2Not reportedNot reportedNot reportedNot reported
Decitabine 0.2mg/kg + Tetrahydrouridine 10mg/kg Every (q) Tuesday,Wednesday (TW) x 2 Weeks q3Weeks1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      4
    units
    Participants
description
A DLT is any Grade 3 (severe) or greater toxicity that cannot be attributed to a cause other than study treatment during the first two cycles of Course 1 of therapy such as disease progression or intercurrent illness.
groups
  1. description
    Phase 1, Arm 1, Dose Escalation, ORIGINAL Dose Level 1: Participants received Decitabine 0.2mg/kg + Tetrahydrouridine 10mg/kg Sunday, Monday, Tuesday (SuMT) q week with Pembrolizumab infusion q3weeks
    id
    OG000
    title
    Decitabine 0.2mg/kg + Tetrahydrouridine 10mg/kg Sunday, Monday, Tuesday (SuMT)
  2. description
    Phase 1, Arm 1, Dose Escalation, ORIGINAL Dose Level -1: Participants received Decitabine 0.2mg/kg + Tetrahydrouridine 10mg/kg Monday-Tuesday (MT) q week. Participants received Pembrolizumab infusion q3weeks.
    id
    OG001
    title
    Decitabine 0.2mg/kg + Tetrahydrouridine 10mg/kg Monday-Tuesday (MT)
  3. description
    Phase 1, Arm 1, Dose Escalation, Revised Dose Level 1. Participants received Decitabine 0.21 mg/kg + Tetrahydrouridine 10mg/kg TW weekly x 2 weeks q 3 weeks. Participants received pembrolizumab infusion q 3weeks.
    id
    OG002
    title
    Decitabine 0.2mg/kg + Tetrahydrouridine 10mg/kg Every (q) Tuesday,Wednesday (TW) x 2 Weeks q3Weeks
param Type
COUNT_OF_PARTICIPANTS
population Description
1/9 participants did not receive any therapy.
reporting Status
POSTED
time Frame
First two cycles of Course 1 of therapy
title
Number of Participants With a Dose Limiting Hematologic Toxicity (DLT)
type
OTHER_PRE_SPECIFIED
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice