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NCT01154452 · OUTCOME

Response Rate (CR + PR) as Assessed by RECIST 1.1 (Phase Ib and II)

Vismodegib and Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced or Metastatic Sarcoma · Source last updated 2018-08-15

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Up to 4 months

What was measured

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions

Groups in this outcome

RO4929097 10mg

RO4929097: 10mg PO QD, GDC-0449: 150 mg PO QD

RO4929097 15 mg

RO4929097: 15 mg PO QD, GDC-0449: 150 mg PO QD

ARM 1 - RO4929097: 15 mg PO QD

ARM 1 - RO4929097: 15 mg PO QD

ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD

ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO 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
RO4929097 10mg3
RO4929097 15 mg3
ARM 1 - RO4929097: 15 mg PO QD30
ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD27

Reported measurements

Stable Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
RO4929097 10mg2Not reportedNot reportedNot reportedNot reported
RO4929097 15 mg2Not reportedNot reportedNot reportedNot reported
ARM 1 - RO4929097: 15 mg PO QD17Not reportedNot reportedNot reportedNot reported
ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD16Not reportedNot reportedNot reportedNot reported
Progression of Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
RO4929097 10mg1Not reportedNot reportedNot reportedNot reported
RO4929097 15 mg1Not reportedNot reportedNot reportedNot reported
ARM 1 - RO4929097: 15 mg PO QD13Not reportedNot reportedNot reportedNot reported
ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD11Not 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
        17
      4. group Id
        OG003
        value
        16
    title
    Stable Disease
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        13
      4. group Id
        OG003
        value
        11
    title
    Progression of Disease
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      30
    4. group Id
      OG003
      value
      27
    units
    Participants
description
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions
groups
  1. description
    RO4929097: 10mg PO QD, GDC-0449: 150 mg PO QD
    id
    OG000
    title
    RO4929097 10mg
  2. description
    RO4929097: 15 mg PO QD, GDC-0449: 150 mg PO QD
    id
    OG001
    title
    RO4929097 15 mg
  3. description
    ARM 1 - RO4929097: 15 mg PO QD
    id
    OG002
    title
    ARM 1 - RO4929097: 15 mg PO QD
  4. description
    ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD
    id
    OG003
    title
    ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 4 months
title
Response Rate (CR + PR) as Assessed by RECIST 1.1 (Phase Ib and II)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice