NCT03480750 · STUDY IN CONTEXT

Trial of Trientine Plus Pegylated Liposomal Doxorubicin and Carboplatin in Epithelial Ovarian Cancer

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

(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

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.

→

secondary · POSTED

'3+3' study design. MTD will be defined at the dose level of trientine prior to the level with DLT events ≧ 2/6 participants.

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.

→

secondary · POSTED

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

Source null

→

secondary · POSTED

Time is calculated from the diagnosis to the last follow-up date if no disease progression , or the date of disease progression after the last treatment cycle of the study drugs

According the protocol for this secondary outcome, data collected from participants receiving different dose levels were intended to be combined and analyzed as a single group.

→

secondary · POSTED

Time is calculated from the diagnosis to the date of the last follow-up date if no death event, or the date of death.

According the protocol for this secondary outcome, data collected from participants receiving different dose levels were intended to be combined and analyzed as a single group

→

secondary · POSTED

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan

Two participants who declined any of the study agents after enrollment or declined the initial chemotherapy drug after a 7-day course of trientine were deemed ineligible for this analysis. According the protocol for this secondary outcome, all participants were not described separately.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-malignant-peritoneal-neoplasm
nct id: NCT03480750
trial label: Trial of Trientine Plus Pegylated Liposomal Doxorubicin and Carboplatin in Epithelial Ovarian Cancer
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 6
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm
nct id
NCT03480750
outcome key
om-0000
source section id
NCT03480750-om-0000
source outcome index
0
endpoint
Number of Participants With Dose-Limiting Toxicity (DLT)
endpoint definition
(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
time origin
36 days
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm
nct id
NCT03480750
outcome key
om-0001
source section id
NCT03480750-om-0001
source outcome index
1
endpoint
Maximum Tolerated Dose, MTD
endpoint definition
'3+3' study design. MTD will be defined at the dose level of trientine prior to the level with DLT events ≧ 2/6 participants.
time origin
within 36 days after the start of Trientine
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm
nct id
NCT03480750
outcome key
om-0002
source section id
NCT03480750-om-0002
source outcome index
2
endpoint
Maximum Plasma Concentration [Cmax] of Trientine
endpoint definition
Trientine (TETA) prior to and within 24 hrs and 7 days after trientine
time origin
0, 10mins, 30mins, 60mins, 90mins, 120mins, 4h, 6h, 24h, 148h, 150h, 153h, 156h post 1st dose of trientine
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm
nct id
NCT03480750
outcome key
om-0003
source section id
NCT03480750-om-0003
source outcome index
3
endpoint
Progression-free Survival
endpoint definition
Time is calculated from the diagnosis to the last follow-up date if no disease progression , or the date of disease progression after the last treatment cycle of the study drugs
time origin
36 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
According the protocol for this secondary outcome, data collected from participants receiving different dose levels were intended to be combined and analyzed as a single group.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm
nct id
NCT03480750
outcome key
om-0004
source section id
NCT03480750-om-0004
source outcome index
4
endpoint
Overall Survival
endpoint definition
Time is calculated from the diagnosis to the date of the last follow-up date if no death event, or the date of death.
time origin
36 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
According the protocol for this secondary outcome, data collected from participants receiving different dose levels were intended to be combined and analyzed as a single group
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm
nct id
NCT03480750
outcome key
om-0005
source section id
NCT03480750-om-0005
source outcome index
5
endpoint
Percentage of Participants With Measurable Tumor Treatment Response Assessed by RECIST Criteria 1.1
endpoint definition
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan
time origin
176 days
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Two participants who declined any of the study agents after enrollment or declined the initial chemotherapy drug after a 7-day course of trientine were deemed ineligible for this analysis. According the protocol for this secondary outcome, all participants were not described separately.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm
nct id
NCT03480750
outcome key
om-0000
arm key
OG000
arm label
Trientine With Chemotherapy at Dose Level 1 (300mg/d)
regimen
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
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03480750-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm
nct id
NCT03480750
outcome key
om-0000
arm key
OG001
arm label
Trientine With Chemotherapy at Dose Level 2 (600mg/d)
regimen
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
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03480750-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm
nct id
NCT03480750
outcome key
om-0000
arm key
OG002
arm label
Trientine With Chemotherapy at Dose Level 3 (900mg/d)
regimen
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
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03480750-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm
nct id
NCT03480750
outcome key
om-0000
arm key
OG003
arm label
Trientine With Chemotherapy at Dose Level 4 (1200mg/d)
regimen
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
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03480750-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm
nct id
NCT03480750
outcome key
om-0000
arm key
OG004
arm label
Trientine With Chemotherapy Dose Level 5 (1500mg/d)
regimen
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
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03480750-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm
nct id
NCT03480750
outcome key
om-0000
arm key
OG005
arm label
Trientine With Chemotherapy Dose Level 6 (1800mg/d)
regimen
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
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03480750-om-0000#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm
nct id
NCT03480750
outcome key
om-0001
arm key
OG000
arm label
Trientine With Chemotherapy Dose Level 1 - 6 (300 -1800mg)
regimen
trientine dihydrochloride: trientine dihydrochloride 300 - 1800MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03480750-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm
nct id
NCT03480750
outcome key
om-0002
arm key
OG000
arm label
Trientine With Chemotherapy Dose Level 1 (300mg)
regimen
trientine dihydrochloride: trientine dihydrochloride 300MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03480750-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm
nct id
NCT03480750
outcome key
om-0002
arm key
OG001
arm label
Trientine With Chemotherapy Dose Level 2 (600mg)
regimen
trientine dihydrochloride: trientine dihydrochloride 600MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03480750-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm
nct id
NCT03480750
outcome key
om-0002
arm key
OG002
arm label
Trientine With Chemotherapy Dose Level 3 (900mg)
regimen
trientine dihydrochloride: trientine dihydrochloride 900MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03480750-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm
nct id
NCT03480750
outcome key
om-0002
arm key
OG003
arm label
Trientine With Chemotherapy Dose Level 4 (1200mg)
regimen
trientine dihydrochloride: trientine dihydrochloride 1200MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03480750-om-0002#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm
nct id
NCT03480750
outcome key
om-0002
arm key
OG004
arm label
Trientine With Chemotherapy Dose Level 5 (1500mg)
regimen
trientine dihydrochloride: trientine dihydrochloride 1500MG/CAPSUE PO daily pegylated liposomal doxorubicin: pegylated liposomal doxorubicin 40mg/m2 IV D1 carboplatin: carboplatin AUC 4 IV D1
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03480750-om-0002#groups/OG004

harms

release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm
nct id
NCT03480750
harm key
EG000
source section id
NCT03480750-ae
event group key
EG000
event group label
Trientine With Chemotherapy Dose Level 1 (300mg)
serious affected
0
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
All-Cause Mortality was assessed up to 36 months and Serious and Other (non-serious) Adverse Events were assessed within the planned 6-month treatment duration
event definition
Adverse event severity was graded according to the Common Terminology Criteria for Adverse Events, version 4.03. All participants who received at least one dose of any of the study agents were considered evaluable for safety.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm
nct id
NCT03480750
harm key
EG001
source section id
NCT03480750-ae
event group key
EG001
event group label
Trientine With Chemotherapy Dose Level 2 (600mg)
serious affected
0
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
All-Cause Mortality was assessed up to 36 months and Serious and Other (non-serious) Adverse Events were assessed within the planned 6-month treatment duration
event definition
Adverse event severity was graded according to the Common Terminology Criteria for Adverse Events, version 4.03. All participants who received at least one dose of any of the study agents were considered evaluable for safety.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm
nct id
NCT03480750
harm key
EG002
source section id
NCT03480750-ae
event group key
EG002
event group label
Trientine With Chemotherapy Dose Level 3 (900mg)
serious affected
1
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
All-Cause Mortality was assessed up to 36 months and Serious and Other (non-serious) Adverse Events were assessed within the planned 6-month treatment duration
event definition
Adverse event severity was graded according to the Common Terminology Criteria for Adverse Events, version 4.03. All participants who received at least one dose of any of the study agents were considered evaluable for safety.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm
nct id
NCT03480750
harm key
EG003
source section id
NCT03480750-ae
event group key
EG003
event group label
Trientine With Chemotherapy Dose Level 4 (1200mg)
serious affected
0
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
All-Cause Mortality was assessed up to 36 months and Serious and Other (non-serious) Adverse Events were assessed within the planned 6-month treatment duration
event definition
Adverse event severity was graded according to the Common Terminology Criteria for Adverse Events, version 4.03. All participants who received at least one dose of any of the study agents were considered evaluable for safety.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm
nct id
NCT03480750
harm key
EG004
source section id
NCT03480750-ae
event group key
EG004
event group label
Trientine With Chemotherapy Dose Level 5 (1500mg)
serious affected
0
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
All-Cause Mortality was assessed up to 36 months and Serious and Other (non-serious) Adverse Events were assessed within the planned 6-month treatment duration
event definition
Adverse event severity was graded according to the Common Terminology Criteria for Adverse Events, version 4.03. All participants who received at least one dose of any of the study agents were considered evaluable for safety.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm
nct id
NCT03480750
harm key
EG005
source section id
NCT03480750-ae
event group key
EG005
event group label
Trientine With Chemotherapy Dose Level 6 (1800mg)
serious affected
0
serious at risk
2
other affected
2
other at risk
2
frequency threshold
0
collection period
All-Cause Mortality was assessed up to 36 months and Serious and Other (non-serious) Adverse Events were assessed within the planned 6-month treatment duration
event definition
Adverse event severity was graded according to the Common Terminology Criteria for Adverse Events, version 4.03. All participants who received at least one dose of any of the study agents were considered evaluable for safety.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice