NCT03480750 · OUTCOME

Maximum Plasma Concentration [Cmax] of Trientine

Trial of Trientine Plus Pegylated Liposomal Doxorubicin and Carboplatin in Epithelial Ovarian Cancer · Source last updated 2020-11-10

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

Measure: MEDIAN
Unit: mg/L
Interval / dispersion: Inter-Quartile Range
Time frame: 0, 10mins, 30mins, 60mins, 90mins, 120mins, 4h, 6h, 24h, 148h, 150h, 153h, 156h post 1st dose of trientine

What was measured

Trientine (TETA) prior to and within 24 hrs and 7 days after trientine

Groups in this outcome

Trientine With Chemotherapy Dose Level 1 (300mg)

trientine dihydrochloride: trientine dihydrochloride 300MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1

Trientine With Chemotherapy Dose Level 2 (600mg)

trientine dihydrochloride: trientine dihydrochloride 600MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1

Trientine With Chemotherapy Dose Level 3 (900mg)

trientine dihydrochloride: trientine dihydrochloride 900MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1

Trientine With Chemotherapy Dose Level 4 (1200mg)

trientine dihydrochloride: trientine dihydrochloride 1200MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1

Trientine With Chemotherapy Dose Level 5 (1500mg)

trientine dihydrochloride: trientine dihydrochloride 1500MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1

Trientine With Chemotherapy Dose Level 6 (1800mg)

trientine dihydrochloride: trientine dihydrochloride 1800MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1

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
Trientine With Chemotherapy Dose Level 1 (300mg)	3
Trientine With Chemotherapy Dose Level 2 (600mg)	3
Trientine With Chemotherapy Dose Level 3 (900mg)	3
Trientine With Chemotherapy Dose Level 4 (1200mg)	3
Trientine With Chemotherapy Dose Level 5 (1500mg)	3
Trientine With Chemotherapy Dose Level 6 (1800mg)	2

Reported measurements

Source class 1

Values in mg/L · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
Trientine With Chemotherapy Dose Level 1 (300mg)	1.87	Not reported	1.01	2.73	Not reported
Trientine With Chemotherapy Dose Level 2 (600mg)	5.07	Not reported	0.83	9.31	Not reported
Trientine With Chemotherapy Dose Level 3 (900mg)	11.54	Not reported	3.31	19.76	Not reported
Trientine With Chemotherapy Dose Level 4 (1200mg)	14.98	Not reported	8.95	21.01	Not reported
Trientine With Chemotherapy Dose Level 5 (1500mg)	13.08	Not reported	0	27.1	Not reported
Trientine With Chemotherapy Dose Level 6 (1800mg)	29.35	Not reported	0	29.35	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
1.01
upper Limit
2.73
value
1.87
group Id
OG001
lower Limit
0.83
upper Limit
9.31
value
5.07
group Id
OG002
lower Limit
3.31
upper Limit
19.76
value
11.54
group Id
OG003
lower Limit
8.95
upper Limit
21.01
value
14.98
group Id
OG004
lower Limit
0
upper Limit
27.1
value
13.08
group Id
OG005
lower Limit
0
upper Limit
29.35
value
29.35

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
3
group Id
OG004
value
3
group Id
OG005
value
2
units
Participants

description

Trientine (TETA) prior to and within 24 hrs and 7 days after trientine

dispersion Type

Inter-Quartile Range

groups

description
trientine dihydrochloride: trientine dihydrochloride 300MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
id
OG000
title
Trientine With Chemotherapy Dose Level 1 (300mg)
description
trientine dihydrochloride: trientine dihydrochloride 600MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
id
OG001
title
Trientine With Chemotherapy Dose Level 2 (600mg)
description
trientine dihydrochloride: trientine dihydrochloride 900MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
id
OG002
title
Trientine With Chemotherapy Dose Level 3 (900mg)
description
trientine dihydrochloride: trientine dihydrochloride 1200MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
id
OG003
title
Trientine With Chemotherapy Dose Level 4 (1200mg)
description
trientine dihydrochloride: trientine dihydrochloride 1500MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
id
OG004
title
Trientine With Chemotherapy Dose Level 5 (1500mg)
description
trientine dihydrochloride: trientine dihydrochloride 1800MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
id
OG005
title
Trientine With Chemotherapy Dose Level 6 (1800mg)

param Type

MEDIAN

reporting Status

POSTED

time Frame

0, 10mins, 30mins, 60mins, 90mins, 120mins, 4h, 6h, 24h, 148h, 150h, 153h, 156h post 1st dose of trientine

title

Maximum Plasma Concentration [Cmax] of Trientine

type

SECONDARY

unit Of Measure

mg/L

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

Preserved source evidence · Not medical advice