NCT01063907 · OUTCOME

Phase 1: PK Elimination t½ hr Day 11

A Study of KW-2478 in Combination With Bortezomib in Subjects With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2024-04-25

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

Measure: MEAN
Unit: hr
Interval / dispersion: Standard Deviation
Time frame: PK collected Day 11 of 21-day cycle

What was measured

Descriptive summary statistics (number, arithmetic mean, standard deviation \[SDev\], coefficient of variation \[CV%\]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.

Analysis population: The PK of KW-2478 was characterized after single administrations through @25 hours post start of infusion dose on Day 1 and through @7 hours post start of infusion dose on Day 11in Phase 1 only.

Groups in this outcome

Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2

Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle

Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2

Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle

Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2

Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle

Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2

Both agents administered on Days 1, 4, 8 and 11 of a 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
Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2	3
Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2	3
Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2	3
Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2	6

Reported measurements

Source class 1

Values in hr · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2	1.88	0.076	Not reported	Not reported	Not reported
Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2	2.02	0	Not reported	Not reported	Not reported
Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2	1.84	0.206	Not reported	Not reported	Not reported
Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2	1.77	0.262	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.076
value
1.88
group Id
OG001
spread
0
value
2.02
group Id
OG002
spread
0.206
value
1.84
group Id
OG003
spread
0.262
value
1.77

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
6
units
Participants

description

dispersion Type

Standard Deviation

groups

description
Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
id
OG000
title
Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2
description
Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
id
OG001
title
Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2
description
Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
id
OG002
title
Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2
description
Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
id
OG003
title
Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2

param Type

MEAN

population Description

The PK of KW-2478 was characterized after single administrations through @25 hours post start of infusion dose on Day 1 and through @7 hours post start of infusion dose on Day 11in Phase 1 only.

reporting Status

POSTED

time Frame

PK collected Day 11 of 21-day cycle

title

Phase 1: PK Elimination t½ hr Day 11

type

SECONDARY

unit Of Measure

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

Preserved source evidence · Not medical advice