NCT01154452 · OUTCOME

Maximum-tolerated Dose of Gamma-secretase Inhibitor RO4929097, Defined as the Dose Level Where no More Than 1 Out of 6 Patients Experience DLT at the Highest Dose Level Below the MAD, Graded According to NCI-CTCAE Version 4.0 (Phase Ib)

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: mg
Interval / dispersion: Not reported
Time frame: Up to 28 days

Groups in this outcome

All Phase Ib Participants

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

Analysis denominator · Participants

Group	Source count
All Phase Ib Participants	10

Reported measurements

Source class 1

Values in mg · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
All Phase Ib Participants	15	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
15

denoms

counts
group Id
OG000
value
10
units
Participants

groups

description
All Phase Ib Participants
id
OG000
title
All Phase Ib Participants

param Type

NUMBER

reporting Status

POSTED

time Frame

Up to 28 days

title

Maximum-tolerated Dose of Gamma-secretase Inhibitor RO4929097, Defined as the Dose Level Where no More Than 1 Out of 6 Patients Experience DLT at the Highest Dose Level Below the MAD, Graded According to NCI-CTCAE Version 4.0 (Phase Ib)

type

PRIMARY

unit Of Measure

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

Preserved source evidence · Not medical advice