NCT03480750 · OUTCOME

Number of Participants With Dose-Limiting Toxicity (DLT)

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: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: 36 days

What was measured

(1) Grade 4 neutropenia (ANC \<500/cumm\^3) or thrombocytopenia ≧7 days; (2) Hematologic toxicities ≧ Grade 3, eg. febrile neutropenia \<1,000/cumm\^3, or platelet count \<25,000/cumm\^3 with hemorrhage ≧ 7 days; (3) Non-hematologic toxicities ≧ grade 3, eg. ALT or AST, ≧ 7days; other non-hematologic toxicities ≧ grade 3 (except alopecia, non-chemotherapy related nausea/vomiting); (4) Neurologic toxicities ≧ grade 2, eg. dizziness, or lethargy ≧ 3 days

Analysis population: One participant receiving 600 mg/day declined the trial drugs and did not proceed with treatment.Therefore, an additional participant was included at the same dose level.

Groups in this outcome

Trientine With Chemotherapy at Dose Level 1 (300mg/d)

trientine dihydrochloride PO daily plus pegylated liposomal doxorubicin IV D1 plus carboplatin IV D1 trientine dihydrochloride: trientine dihydrochloride 300MG/CAPSUE PO daily (at 1st dose level: 300mg) pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1

Trientine With Chemotherapy at Dose Level 2 (600mg/d)

rientine dihydrochloride PO daily plus pegylated liposomal doxorubicin IV D1 plus carboplatin IV D1 trientine dihydrochloride: trientine dihydrochloride 300MG/CAPSUE PO daily (at 2nd dose level: 600mg) pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1

Trientine With Chemotherapy at Dose Level 3 (900mg/d)

trientine dihydrochloride PO daily plus pegylated liposomal doxorubicin IV D1 plus carboplatin IV D1 trientine dihydrochloride: trientine dihydrochloride 300MG/CAPSUE PO daily (at 3rd dose level: 900mg) pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1

Trientine With Chemotherapy at Dose Level 4 (1200mg/d)

trientine dihydrochloride PO daily plus pegylated liposomal doxorubicin IV D1 plus carboplatin IV D1 trientine dihydrochloride: trientine dihydrochloride 300MG/CAPSUE PO daily (at 4th dose level: 1200mg) pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1

Trientine With Chemotherapy Dose Level 5 (1500mg/d)

trientine dihydrochloride PO daily plus pegylated liposomal doxorubicin IV D1 plus carboplatin IV D1 trientine dihydrochloride: trientine dihydrochloride 300MG/CAPSUE PO daily (at 5th dose level: 1500mg) pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1

Trientine With Chemotherapy Dose Level 6 (1800mg/d)

trientine dihydrochloride PO daily plus pegylated liposomal doxorubicin IV D1 plus carboplatin IV D1 trientine dihydrochloride: trientine dihydrochloride 300MG/CAPSUE PO daily (at 6th dose level: 1800mg) 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 at Dose Level 1 (300mg/d)	3
Trientine With Chemotherapy at Dose Level 2 (600mg/d)	3
Trientine With Chemotherapy at Dose Level 3 (900mg/d)	3
Trientine With Chemotherapy at Dose Level 4 (1200mg/d)	3
Trientine With Chemotherapy Dose Level 5 (1500mg/d)	3
Trientine With Chemotherapy Dose Level 6 (1800mg/d)	2

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Trientine With Chemotherapy at Dose Level 1 (300mg/d)	Not reported	Not reported	Not reported	Not reported
Trientine With Chemotherapy at Dose Level 2 (600mg/d)	Not reported	Not reported	Not reported	Not reported
Trientine With Chemotherapy at Dose Level 3 (900mg/d)	Not reported	Not reported	Not reported	Not reported
Trientine With Chemotherapy at Dose Level 4 (1200mg/d)	Not reported	Not reported	Not reported	Not reported
Trientine With Chemotherapy Dose Level 5 (1500mg/d)	Not reported	Not reported	Not reported	Not reported
Trientine With Chemotherapy Dose Level 6 (1800mg/d)	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0

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

groups

description
trientine dihydrochloride PO daily plus pegylated liposomal doxorubicin IV D1 plus carboplatin IV D1 trientine dihydrochloride: trientine dihydrochloride 300MG/CAPSUE PO daily (at 1st dose level: 300mg) pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
id
OG000
title
Trientine With Chemotherapy at Dose Level 1 (300mg/d)
description
rientine dihydrochloride PO daily plus pegylated liposomal doxorubicin IV D1 plus carboplatin IV D1 trientine dihydrochloride: trientine dihydrochloride 300MG/CAPSUE PO daily (at 2nd dose level: 600mg) pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
id
OG001
title
Trientine With Chemotherapy at Dose Level 2 (600mg/d)
description
trientine dihydrochloride PO daily plus pegylated liposomal doxorubicin IV D1 plus carboplatin IV D1 trientine dihydrochloride: trientine dihydrochloride 300MG/CAPSUE PO daily (at 3rd dose level: 900mg) pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1
id
OG002
title
Trientine With Chemotherapy at Dose Level 3 (900mg/d)
description
trientine dihydrochloride PO daily plus pegylated liposomal doxorubicin IV D1 plus carboplatin IV D1 trientine dihydrochloride: trientine dihydrochloride 300MG/CAPSUE PO daily (at 4th dose level: 1200mg) pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
id
OG003
title
Trientine With Chemotherapy at Dose Level 4 (1200mg/d)
description
trientine dihydrochloride PO daily plus pegylated liposomal doxorubicin IV D1 plus carboplatin IV D1 trientine dihydrochloride: trientine dihydrochloride 300MG/CAPSUE PO daily (at 5th dose level: 1500mg) 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/d)
description
trientine dihydrochloride PO daily plus pegylated liposomal doxorubicin IV D1 plus carboplatin IV D1 trientine dihydrochloride: trientine dihydrochloride 300MG/CAPSUE PO daily (at 6th dose level: 1800mg) 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/d)

param Type

COUNT_OF_PARTICIPANTS

population Description

One participant receiving 600 mg/day declined the trial drugs and did not proceed with treatment.Therefore, an additional participant was included at the same dose level.

reporting Status

POSTED

time Frame

36 days

title

Number of Participants With Dose-Limiting Toxicity (DLT)

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice