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NCT02797964 · OUTCOME

Recommended Phase 2 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
Up to 30 days after last dose of SRA737

What was measured

The RP2D and schedule were defined by the Cohort Review Committee at the end of the study and took all clinically relevant toxicity, PK and PDn data into account. The RP2D was to be a dose equal to or less than the MTD for the selected schedule.

Analysis population: All 107 subjects treated in the study were included in the review of toxicity, PK and PDn, data in order to determine the RP2D. All clinically relevant toxicity, PK and PDn data up to 30 days after last dose of SRA737 were taken into account.

Groups in this outcome

Safety Evaluable Population

The Safety Evaluable Population includes all enrolled subjects who receive at least 1 dose of SRA737.

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

Analysis denominator · Participants

GroupSource count
Safety Evaluable Population107

Reported measurements

Source class 1
Values in mg QD · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Evaluable Population800Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        800
denoms
  1. counts
    1. group Id
      OG000
      value
      107
    units
    Participants
description
The RP2D and schedule were defined by the Cohort Review Committee at the end of the study and took all clinically relevant toxicity, PK and PDn data into account. The RP2D was to be a dose equal to or less than the MTD for the selected schedule.
groups
  1. description
    The Safety Evaluable Population includes all enrolled subjects who receive at least 1 dose of SRA737.
    id
    OG000
    title
    Safety Evaluable Population
param Type
NUMBER
population Description
All 107 subjects treated in the study were included in the review of toxicity, PK and PDn, data in order to determine the RP2D. All clinically relevant toxicity, PK and PDn data up to 30 days after last dose of SRA737 were taken into account.
reporting Status
POSTED
time Frame
Up to 30 days after last dose of SRA737
title
Recommended Phase 2 Dose of SRA737
type
PRIMARY
unit Of Measure
mg QD

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

Preserved source evidence · Not medical advice