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NCT01177397 · OUTCOME

Part B: Progression Free Survival (PFS) Rate at 6 Months for GBM Participants

Study to Assess Safety, Pharmacokinetics, and Efficacy of Oral CC-223 for Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma or Multiple Myeloma · Source last updated 2022-12-13

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

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From first dose to 6 months

What was measured

Progression free survival rate of GBM participants at 6 months is defined as the percentage of participants without progressive disease per Evaluation Criteria in Solid Tumors (RECIST) 1.1 6 months after starting study treatment. Progressive disease is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

Analysis population: All treated participants in Part B with GBM without progression per RECIST 1.0 at 6 months

Groups in this outcome

Part B: Glioblastoma Multiforme (GBM)

Participants with GBM received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.

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

Analysis denominator · Participants

GroupSource count
Part B: Glioblastoma Multiforme (GBM)13

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part B: Glioblastoma Multiforme (GBM)0Not reportedNANALower and upper limit not reached to insufficient number of events
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Lower and upper limit not reached to insufficient number of events
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    units
    Participants
description
Progression free survival rate of GBM participants at 6 months is defined as the percentage of participants without progressive disease per Evaluation Criteria in Solid Tumors (RECIST) 1.1 6 months after starting study treatment. Progressive disease is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with GBM received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
    id
    OG000
    title
    Part B: Glioblastoma Multiforme (GBM)
param Type
NUMBER
population Description
All treated participants in Part B with GBM without progression per RECIST 1.0 at 6 months
reporting Status
POSTED
time Frame
From first dose to 6 months
title
Part B: Progression Free Survival (PFS) Rate at 6 Months for GBM Participants
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice