NCT00661609 · OUTCOME

Objective Response Rate (ORR) as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST)

A Phase II Study of AZD4877 (a Novel Anti-mitotic Agent) in Advanced Bladder Cancer · Source last updated 2011-01-12

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

Measure: NUMBER
Unit: Percengate of participants
Interval / dispersion: Not reported
Time frame: 8 weeks after study drug begins & and every 8 wks thereafter until discontinuation of study drug ( maximum treatment period of 309 days (44 weeks)

What was measured

Percentage of participants with complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST), version 1.0 (Therasse et al. Natl Cancer Inst 92 (2000) pp205-216).

Analysis population: Of the 41 participants who received at least one dose of study medication, only 39 were evaluable for response by RECIST (excludes 2 patients who had baseline scans performed more than 28 days before dosing).

Groups in this outcome

AZD4877

AZD4877 25 mg (Intravenous (IV), 25mg weekly)

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
AZD4877	39

Reported measurements

Source class 1

Values in Percengate of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AZD4877	2.6	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
2.6

denoms

counts
group Id
OG000
value
39
units
Participants

description

groups

description
AZD4877 25 mg (Intravenous (IV), 25mg weekly)
id
OG000
title
AZD4877

param Type

NUMBER

population Description

Of the 41 participants who received at least one dose of study medication, only 39 were evaluable for response by RECIST (excludes 2 patients who had baseline scans performed more than 28 days before dosing).

reporting Status

POSTED

time Frame

8 weeks after study drug begins & and every 8 wks thereafter until discontinuation of study drug ( maximum treatment period of 309 days (44 weeks)

title

Objective Response Rate (ORR) as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST)

type

PRIMARY

unit Of Measure

Percengate of participants

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

Preserved source evidence · Not medical advice