Trial · NCT03480750
Trial of Trientine Plus Pegylated Liposomal Doxorubicin and Carboplatin in Epithelial Ovarian Cancer
NCT03480750, Phase 1, Phase 2, Completed, National Cheng-Kung University Hospital; results first posted 2020-11-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial of Trientine Plus Pegylated Liposomal Doxorubicin and Carboplatin in Epithelial Ovarian Cancer. Trials, record NCT03480750. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03480750
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Trientine Plus Pegylated Liposomal Doxorubicin and Carboplatin in Epithelial Ovarian Cancer
- NCT number
- NCT03480750
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- National Cheng-Kung University Hospital
- Conditions
- Ovarian Neoplasms Malignant (Excl Germ Cell), Peritoneal Carcinoma, Fallopian Tube Cancer
- Interventions
- trientine dihydrochloride, pegylated liposomal doxorubicin, carboplatin
- First posted
- 2018-03-29
- Last updated
- 2020-11-10
- Results first posted
- 2020-11-10
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose-Limiting Toxicity (DLT) | 36 days | (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 |
| Secondary | Maximum Tolerated Dose, MTD | within 36 days after the start of Trientine | '3+3' study design. MTD will be defined at the dose level of trientine prior to the level with DLT events ≧ 2/6 participants. |
| Secondary | Maximum Plasma Concentration [Cmax] of Trientine | 0, 10mins, 30mins, 60mins, 90mins, 120mins, 4h, 6h, 24h, 148h, 150h, 153h, 156h post 1st dose of trientine | Trientine (TETA) prior to and within 24 hrs and 7 days after trientine |
| Secondary | Progression-free Survival | 36 months | 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 |
| Secondary | Overall Survival | 36 months | Time is calculated from the diagnosis to the date of the last follow-up date if no death event, or the date of death. |
| Secondary | Percentage of Participants With Measurable Tumor Treatment Response Assessed by RECIST Criteria 1.1 | 176 days | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose-Limiting Toxicity (DLT) | 36 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maximum Tolerated Dose, MTD | within 36 days after the start of Trientine | 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. | mg | NUMBER |
| SECONDARY | Maximum Plasma Concentration [Cmax] of Trientine | 0, 10mins, 30mins, 60mins, 90mins, 120mins, 4h, 6h, 24h, 148h, 150h, 153h, 156h post 1st dose of trientine | mg/L | MEDIAN | |
| SECONDARY | Progression-free Survival | 36 months | 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. | months | MEDIAN |
| SECONDARY | Overall Survival | 36 months | 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 | months | MEDIAN |
| SECONDARY | Percentage of Participants With Measurable Tumor Treatment Response Assessed by RECIST Criteria 1.1 | 176 days | 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. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose-Limiting Toxicity (DLT) | Trientine With Chemotherapy at Dose Level 1 (300mg/d) | 0 | Participants | ||
| Number of Participants With Dose-Limiting Toxicity (DLT) | Trientine With Chemotherapy at Dose Level 2 (600mg/d) | 0 | Participants | ||
| Number of Participants With Dose-Limiting Toxicity (DLT) | Trientine With Chemotherapy at Dose Level 3 (900mg/d) | 0 | Participants | ||
| Number of Participants With Dose-Limiting Toxicity (DLT) | Trientine With Chemotherapy at Dose Level 4 (1200mg/d) | 0 | Participants | ||
| Number of Participants With Dose-Limiting Toxicity (DLT) | Trientine With Chemotherapy Dose Level 5 (1500mg/d) | 0 | Participants | ||
| Number of Participants With Dose-Limiting Toxicity (DLT) | Trientine With Chemotherapy Dose Level 6 (1800mg/d) | 0 | Participants | ||
| Maximum Tolerated Dose, MTD | Trientine With Chemotherapy Dose Level 1 - 6 (300 -1800mg) | NA | mg | ||
| Maximum Plasma Concentration [Cmax] of Trientine | Trientine With Chemotherapy Dose Level 1 (300mg) | 1.87 | Inter-Quartile Range 1.01 to 2.73 | mg/L | |
| Maximum Plasma Concentration [Cmax] of Trientine | Trientine With Chemotherapy Dose Level 2 (600mg) | 5.07 | Inter-Quartile Range 0.83 to 9.31 | mg/L | |
| Maximum Plasma Concentration [Cmax] of Trientine | Trientine With Chemotherapy Dose Level 3 (900mg) | 11.54 | Inter-Quartile Range 3.31 to 19.76 | mg/L |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Trientine With Chemotherapy Dose Level 1 (300mg) | 3 | |
| Overall Study | STARTED | Trientine With Chemotherapy Dose Level 2 (600mg) | 4 | |
| Overall Study | STARTED | Trientine With Chemotherapy Dose Level 3 (900mg) | 3 | |
| Overall Study | STARTED | Trientine With Chemotherapy Dose Level 4 (1200mg) | 3 | |
| Overall Study | STARTED | Trientine With Chemotherapy Dose Level 5 (1500mg) | 3 | |
| Overall Study | STARTED | Trientine With Chemotherapy Dose Level 6 (1800mg) | 2 | |
| Overall Study | COMPLETED | Trientine With Chemotherapy Dose Level 1 (300mg) | 3 | |
| Overall Study | COMPLETED | Trientine With Chemotherapy Dose Level 2 (600mg) | 3 | |
| Overall Study | COMPLETED | Trientine With Chemotherapy Dose Level 3 (900mg) | 3 | |
| Overall Study | COMPLETED | Trientine With Chemotherapy Dose Level 4 (1200mg) | 3 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events138
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Leukopenia | Investigations | Trientine With Chemotherapy Dose Level 1 (300mg) | 1 | 3 | 1 |
| other | Leukopenia | Investigations | Trientine With Chemotherapy Dose Level 2 (600mg) | 1 | 3 | 1 |
| other | Leukopenia | Investigations | Trientine With Chemotherapy Dose Level 3 (900mg) | 2 | 3 | 2 |
| other | Leukopenia | Investigations | Trientine With Chemotherapy Dose Level 4 (1200mg) | 2 | 3 | 2 |
| other | Leukopenia | Investigations | Trientine With Chemotherapy Dose Level 5 (1500mg) | 3 | 3 | 4 |
| other | Leukopenia | Investigations | Trientine With Chemotherapy Dose Level 6 (1800mg) | 0 | 2 | 0 |
| other | Neutrophil count decreased | Investigations | Trientine With Chemotherapy Dose Level 1 (300mg) | 1 | 3 | 1 |
| other | Neutrophil count decreased | Investigations | Trientine With Chemotherapy Dose Level 2 (600mg) | 0 | 3 | 0 |
| other | Neutrophil count decreased | Investigations | Trientine With Chemotherapy Dose Level 3 (900mg) | 0 | 3 | 0 |
| other | Neutrophil count decreased | Investigations | Trientine With Chemotherapy Dose Level 4 (1200mg) | 1 | 3 | 1 |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Trientine With Chemotherapy Dose Level 1 (300mg) | 2 | 3 |
| Total, all-cause mortality | Trientine With Chemotherapy Dose Level 2 (600mg) | 3 | 3 |
| Total, all-cause mortality | Trientine With Chemotherapy Dose Level 3 (900mg) | 3 | 3 |
| Total, all-cause mortality | Trientine With Chemotherapy Dose Level 4 (1200mg) | 3 | 3 |
| Total, all-cause mortality | Trientine With Chemotherapy Dose Level 5 (1500mg) | 3 | 3 |
| Total, all-cause mortality | Trientine With Chemotherapy Dose Level 6 (1800mg) | 1 | 2 |
| Total, other adverse events | Trientine With Chemotherapy Dose Level 1 (300mg) | 3 | 3 |
| Total, other adverse events | Trientine With Chemotherapy Dose Level 2 (600mg) | 3 | 3 |
| Total, other adverse events | Trientine With Chemotherapy Dose Level 3 (900mg) | 3 | 3 |
| Total, other adverse events | Trientine With Chemotherapy Dose Level 4 (1200mg) | 3 | 3 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31179244 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03480750
GET https://conductscience.org/api/trials/v1/NCT03480750/events?page=2