NCT01282463 · OUTCOME

PK: Cmin Icrucumab

Study of Ramucirumab or Icrucumab (IMC-18F1) With Docetaxel or Docetaxel Alone as Second-Line Therapy in Participants With Bladder,Urethra, Ureter, or Renal Pelvis Carcinoma · Source last updated 2019-09-09

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

Measure: GEOMETRIC_MEAN
Unit: ug/mL
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Cycle 2:Predose,1hr post-EOI;Cycle 3:Predose,EOI,1.5hr,24hr,48hr,72hr,168hr Post EOI

Analysis population: All randomized participants who received at least one dose of study drug and had evaluable PK data for Icrucumab and there was no PK data for Docetaxel arm.

Groups in this outcome

Docetaxel + Icrucumab

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle

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
Docetaxel + Icrucumab	10

Reported measurements

Day 1 Cycle 2

Analysis denominator · Participants

Group	Source count
Docetaxel + Icrucumab	1

Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel + Icrucumab	NA	NA	Not reported	Not reported	Geometric Mean and Geometric Coefficient of Variation was not calculable due to n=1.

Day 1 Cycle 3

Analysis denominator · Participants

Group	Source count
Docetaxel + Icrucumab	4

Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Docetaxel + Icrucumab	153	66	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
comment
Geometric Mean and Geometric Coefficient of Variation was not calculable due to n=1.
group Id
OG000
spread
NA
value
NA
denoms
counts
group Id
OG000
value
1
units
Participants
title
Day 1 Cycle 2
categories
measurements
group Id
OG000
spread
66
value
153
denoms
counts
group Id
OG000
value
4
units
Participants
title
Day 1 Cycle 3

denoms

counts
group Id
OG000
value
10
units
Participants

dispersion Type

Geometric Coefficient of Variation

groups

description
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle
id
OG000
title
Docetaxel + Icrucumab

param Type

GEOMETRIC_MEAN

population Description

All randomized participants who received at least one dose of study drug and had evaluable PK data for Icrucumab and there was no PK data for Docetaxel arm.

reporting Status

POSTED

time Frame

Cycle 2:Predose,1hr post-EOI;Cycle 3:Predose,EOI,1.5hr,24hr,48hr,72hr,168hr Post EOI

title

PK: Cmin Icrucumab

type

SECONDARY

unit Of Measure

ug/mL

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

Preserved source evidence · Not medical advice