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NCT02797964 · OUTCOME

Maximum Tolerated Dose of SRA737

A Phase 1/2 Trial of SRA737 in Subjects With Advanced Cancer · Source last updated 2023-06-18

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

Measure
NUMBER
Unit
mg QD
Interval / dispersion
Not reported
Time frame
Cycle 1 (28 days) in the Dose Escalation Phase

What was measured

The highest dose at which ≤ 33% of subjects have a dose limiting toxicity (DLT) in a cohort of up to 6 subjects.

Analysis population: In order to determine the MTD, a total of 18 subjects were enrolled in the dose escalation phase of the study in 9 dosage cohorts. All subjects receiving at least 75% of planned doses of SRA737 within Cycle 1 and those subjects receiving less than these planned doses of SRA737 due to DLT were considered evaluable for dose review decisions.

Groups in this outcome

Dose Escalation Phase

The Dose Escalation Phase included a total of 18 subjects in 9 different dosage cohorts: 20 mg QD, 40 mg QD, 80 mg QD, 160 mg QD, 300 mg QD, 600 mg QD, 1000 mg QD, 500 mg BID, and 1300 mg QD.

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

Analysis denominator · Participants

GroupSource count
Dose Escalation Phase18

Reported measurements

Source class 1
Values in mg QD · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Escalation Phase1000Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1000
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    units
    Participants
description
The highest dose at which ≤ 33% of subjects have a dose limiting toxicity (DLT) in a cohort of up to 6 subjects.
groups
  1. description
    The Dose Escalation Phase included a total of 18 subjects in 9 different dosage cohorts: 20 mg QD, 40 mg QD, 80 mg QD, 160 mg QD, 300 mg QD, 600 mg QD, 1000 mg QD, 500 mg BID, and 1300 mg QD.
    id
    OG000
    title
    Dose Escalation Phase
param Type
NUMBER
population Description
In order to determine the MTD, a total of 18 subjects were enrolled in the dose escalation phase of the study in 9 dosage cohorts. All subjects receiving at least 75% of planned doses of SRA737 within Cycle 1 and those subjects receiving less than these planned doses of SRA737 due to DLT were considered evaluable for dose review decisions.
reporting Status
POSTED
time Frame
Cycle 1 (28 days) in the Dose Escalation Phase
title
Maximum Tolerated Dose of SRA737
type
PRIMARY
unit Of Measure
mg QD

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

Preserved source evidence · Not medical advice