Trial · NCT01314105
BIBF 1120 + Carboplatin/Pegylated Liposomal Doxorubicin (PLD) in Patients With Advanced Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Cancer
NCT01314105, Phase 1, Completed, Boehringer Ingelheim; results first posted 2014-11-20
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. BIBF 1120 + Carboplatin/Pegylated Liposomal Doxorubicin (PLD) in Patients With Advanced Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Cancer. Trials, record NCT01314105. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01314105
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BIBF 1120 + Carboplatin/Pegylated Liposomal Doxorubicin (PLD) in Patients With Advanced Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Cancer
- NCT number
- NCT01314105
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 19 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Ovarian Neoplasms, Peritoneal Neoplasms
- Interventions
- BIBF 1120 + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min, BIBF 1120+ PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min, BIBF 1120 + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min
- First posted
- 2011-03-14
- Last updated
- 2025-02-13
- Other registries' IDs
- eudract:2010-022523-30
- Results first posted
- 2014-11-20
- Limitations and caveats
Due to interference from doxorubicin, doxorubicinol concentrations could not be determined and doxorubicinol PK parameters could not be evaluated.~Statistics of PK parameters are only estimated when at least 2/3 of the data are evaluable.
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose of Nintedanib Based on the Occurrence of DLTs During Treatment Course 1 | First 28-day treatment cycle | Maximum Tolerated Dose (MTD) of nintedanib in combination with carboplatin and pegylated liposomal doxorubicin based on the occurrence of dose limiting toxicities (DLTs) during treatment course 1. MTD will be determined among the first 6 evaluable patients in each dose level. MTD is the highest dose at which the incidence of DLT is less than 2/6. |
| Primary | Dose Limiting Toxicities During Treatment Course 1 | First 28-day treatment cycle | Number of patients with dose limiting toxicity (DLT) occurring during treatment course 1 The following AEs were to be reported as DLT events if their occurrence was considered to be drug-related: Haematological toxicity: * Any CTCAE grade 4 haematological toxicity * CTCAE grade 4 neutropenia that was not associated with fever ≥38.5°C, if persisting for \>7 days despite adequate supportive treatment * CTCAE grade ≥3 neutropenia of any duration if associated with fever ≥38.5°C * Any CTCAE grade 4 thrombocytopenia * CTCAE grade ≥3 thrombocytopenia if associated with bleeding of CTCAE grade ≥2 Non-haematological toxicity: * CTCAE grade ≥3 diarrhoea despite optimal medical management * CTCAE grade 2 diarrhoea persisting for more than 7 days despite optimal medical management * CTCAE grade ≥2 vomiting despite optimal medical management * ALT and/or AST elevation of CTCAE grade ≥3 * ALT and/or AST elevation of \>3x ULN in conjunction with bilirubin increase \>2x ULN |
| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Nintedanib | 5 minutes (min) before drug administration and 1 hour (h) 2h, 3h, 4h, 6h, 8h, 10h, 24h, 144h, 312h and 456h after drug administration | Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf) of nintedanib during course 1 and course 2 |
| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Drug Concentration (AUC0-tz) of Nintedanib | 5 minutes (min) before drug administration and 1 hour (h) 2h, 3h, 4h, 6h, 8h, 10h, 24h, 144h, 312h and 456h after drug administration | Area under the plasma concentration-time curve from time zero to the time of the last quantifiable drug concentration (AUC0-tz) of nintedanib during course 1 and course 2. |
| Secondary | Maximum Measured Plasma Concentration (Cmax) of Nintedanib | 5 minutes (min) before drug administration and 1 hour (h) 2h, 3h, 4h, 6h, 8h, 10h, 24h, 144h, 312h and 456h after drug administration | Maximum measured plasma concentration (Cmax) of nintedanib during course 1 and course 2 |
| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Carboplatin (Determined as Total Platinum) | 5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 23h 55min, 26h, 28h, 32h, 48h, 168h, 336h and 480h after drug administration | Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf) of carboplatin (determined as total platinum) during treatment course 1 and course 2. |
| Secondary | Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero Extrapolated to Infinity (AUC 0-inf) of Carboplatin During Treatment Course 1 and Course 2 (Determined as Ultrafilterable Platinum) | 5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 23h 55min, 25h, 26h, 27h, 28h, 30h, 32h, and 34h after drug administration | Area under the plasma concentration-time curve over the time interval from zero extrapolated to infinity (AUC 0-inf) of carboplatin during treatment course 1 and course 2 (determined as ultrafilterable platinum). Geometric mean (gMean) and Geometric coefficient of Variation (gCV) were not calculable for treatment course 2 as 2/3 of patients had quantifiable values. |
| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Drug Concentration (AUC0-tz) of Carboplatin (Determined as Total Platinum) | 5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 23h 55min, 26h, 28h, 32h, 48h, 168h, 336h and 480h after drug administration | Area under the plasma concentration-time curve from time zero to the time of the last quantifiable drug concentration (AUC0-tz) of carboplatin during course 1 and course 2 (determined as total platinum). |
| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Drug Concentration (AUC0-tz) of Carboplatin (Determined as Ultrafilterable Platinum) | 5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 23h 55min, 25h, 26h, 27h, 28h, 30h, 32h, and 34h after drug administration | Area under the plasma concentration-time curve from time zero to the time of the last quantifiable drug concentration (AUC0-tz) of carboplatin during course 1 and course 2 (determined as ultrafilterable platinum). |
| Secondary | Maximum Measured Plasma Concentration (Cmax) of Carboplatin (Total Platinum) | 5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 23h 55min, 26h, 28h, 32h, 48h, 168h, 336h and 480h after drug administration | Maximum measured plasma concentration (Cmax) of carboplatin during course 1 and course 2 (determined as total platinum). |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose of Nintedanib Based on the Occurrence of DLTs During Treatment Course 1 | First 28-day treatment cycle | MTD set which included patients in the dose escalation part of the trial who started treatment course 2 and/or took 1 dose of carboplatin and PLD, started nintedanib (nin) and did not miss more than 13 doses of nin and/or took 1 dose of carboplatin and PLD, started nin and discontinued treatment due to a dose limiting toxicity during the MTD period | mg | NUMBER |
| PRIMARY | Dose Limiting Toxicities During Treatment Course 1 | First 28-day treatment cycle | MTD set which included patients in the dose escalation part of the trial who started treatment course 2 and/or took 1 dose of carboplatin and PLD, started nintedanib (nin) and did not miss more than 13 doses of nin and/or took 1 dose of carboplatin and PLD, started nin and discontinued treatment due to a dose limiting toxicity during the MTD period | participants | NUMBER |
| SECONDARY | Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Nintedanib | 5 minutes (min) before drug administration and 1 hour (h) 2h, 3h, 4h, 6h, 8h, 10h, 24h, 144h, 312h and 456h after drug administration | Pharmacokinetic (PK) set: All patients in the treated set who were documented to have received at least one dose of nintedanib and who had at least one valid pharmacokinetic parameter concentration available | nanogram*hour/millilitre (ng*h/mL) | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Drug Concentration (AUC0-tz) of Nintedanib | 5 minutes (min) before drug administration and 1 hour (h) 2h, 3h, 4h, 6h, 8h, 10h, 24h, 144h, 312h and 456h after drug administration | PK set | ng*h/mL | GEOMETRIC_MEAN |
| SECONDARY | Maximum Measured Plasma Concentration (Cmax) of Nintedanib | 5 minutes (min) before drug administration and 1 hour (h) 2h, 3h, 4h, 6h, 8h, 10h, 24h, 144h, 312h and 456h after drug administration | PK set | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Carboplatin (Determined as Total Platinum) | 5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 23h 55min, 26h, 28h, 32h, 48h, 168h, 336h and 480h after drug administration | PK set.Goal is to find MTD for nintedanib,two doses of nintedanib separately displayed.However carboplatin,PLD are given as background,therefore only measured to know exposure.As result displaying all subjects is sufficient.Further we decided to make separate table for MTD dose(200mg nintedanib).Separate table for 150mg nintedanib doesnt add value. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero Extrapolated to Infinity (AUC 0-inf) of Carboplatin During Treatment Course 1 and Course 2 (Determined as Ultrafilterable Platinum) | 5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 23h 55min, 25h, 26h, 27h, 28h, 30h, 32h, and 34h after drug administration | PK set.Goal is to find MTD for nintedanib,two doses of nintedanib separately displayed.However carboplatin,PLD are given as background,therefore only measured to know exposure.As result displaying all subjects is sufficient.Further we decided to make separate table for MTD dose(200mg nintedanib).Separate table for 150mg nintedanib doesnt add value. | ng*h/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Drug Concentration (AUC0-tz) of Carboplatin (Determined as Total Platinum) | 5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 23h 55min, 26h, 28h, 32h, 48h, 168h, 336h and 480h after drug administration | PK set.Goal is to find MTD for nintedanib,two doses of nintedanib separately displayed.However carboplatin,PLD are given as background,therefore only measured to know exposure.As result displaying all subjects is sufficient.Further we decided to make separate table for MTD dose(200mg nintedanib).Separate table for 150mg nintedanib doesnt add value. | ng*h/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Drug Concentration (AUC0-tz) of Carboplatin (Determined as Ultrafilterable Platinum) | 5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 23h 55min, 25h, 26h, 27h, 28h, 30h, 32h, and 34h after drug administration | PK set.Goal is to find MTD for nintedanib,two doses of nintedanib separately displayed.However carboplatin,PLD are given as background,therefore only measured to know exposure.As result displaying all subjects is sufficient.Further we decided to make separate table for MTD dose(200mg nintedanib).Separate table for 150mg nintedanib doesnt add value. | ng*h/mL | GEOMETRIC_MEAN |
| SECONDARY | Maximum Measured Plasma Concentration (Cmax) of Carboplatin (Total Platinum) | 5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 23h 55min, 26h, 28h, 32h, 48h, 168h, 336h and 480h after drug administration | PK set.Goal is to find MTD for nintedanib,two doses of nintedanib separately displayed.However carboplatin,PLD are given as background,therefore only measured to know exposure.As result displaying all subjects is sufficient.Further we decided to make separate table for MTD dose(200mg nintedanib).Separate table for 150mg nintedanib doesnt add value. | ng/mL | GEOMETRIC_MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group98
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose of Nintedanib Based on the Occurrence of DLTs During Treatment Course 1 | Nintedanib 150mg | NA | mg | ||
| Maximum Tolerated Dose of Nintedanib Based on the Occurrence of DLTs During Treatment Course 1 | Nintedanib 200mg | 200 | mg | ||
| Dose Limiting Toxicities During Treatment Course 1 | Nintedanib 150mg | 1 | participants | ||
| Dose Limiting Toxicities During Treatment Course 1 | Nintedanib 200mg | 1 | participants | ||
| Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Nintedanib | Nintedanib 150mg | Treatment Course 1 (150mg: N=5; 200mg: N=10) | 335 | Geometric Coefficient of Variation 88.5 | nanogram*hour/millilitre (ng*h/mL) |
| Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Nintedanib | Nintedanib 200mg | Treatment Course 1 (150mg: N=5; 200mg: N=10) | 482 | Geometric Coefficient of Variation 38.8 | nanogram*hour/millilitre (ng*h/mL) |
| Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Nintedanib | Nintedanib 150mg | Treatment Course 2 (150mg: N=7) | 482 | Geometric Coefficient of Variation 76.1 | nanogram*hour/millilitre (ng*h/mL) |
| Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Nintedanib | Nintedanib 200mg | Treatment Course 2 (150mg: N=7) | NA | Geometric Coefficient of Variation NA | nanogram*hour/millilitre (ng*h/mL) |
| Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Drug Concentration (AUC0-tz) of Nintedanib | Nintedanib 150mg | Treatment Course 1 (150mg: N=6; 200mg: N=11) | 283 | Geometric Coefficient of Variation 70.2 | ng*h/mL |
| Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Drug Concentration (AUC0-tz) of Nintedanib | Nintedanib 200mg | Treatment Course 1 (150mg: N=6; 200mg: N=11) | 422 | Geometric Coefficient of Variation 36.9 | ng*h/mL |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nintedanib 150mg | 7 | |
| Overall Study | STARTED | Nintedanib 200mg | 12 | |
| Overall Study | COMPLETED | Nintedanib 150mg | 0 | |
| Overall Study | COMPLETED | Nintedanib 200mg | 0 | |
| Overall Study | NOT COMPLETED | Nintedanib 150mg | 7 | |
| Overall Study | NOT COMPLETED | Nintedanib 200mg | 12 |
Source ClinicalTrials.gov
Adverse events288
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 | Anaemia | Blood and lymphatic system disorders | Nintedanib 150mg | 5 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | Nintedanib 200mg | 9 | 12 | |
| other | Leukopenia | Blood and lymphatic system disorders | Nintedanib 150mg | 5 | 7 | |
| other | Leukopenia | Blood and lymphatic system disorders | Nintedanib 200mg | 4 | 12 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Nintedanib 150mg | 1 | 7 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Nintedanib 200mg | 0 | 12 | |
| other | Neutropenia | Blood and lymphatic system disorders | Nintedanib 150mg | 6 | 7 | |
| other | Neutropenia | Blood and lymphatic system disorders | Nintedanib 200mg | 12 | 12 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Nintedanib 150mg | 3 | 7 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Nintedanib 200mg | 4 | 12 |
1 to 10 of 288Source ClinicalTrials.gov
See all 288 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nintedanib 150mg | ||
| Total, all-cause mortality | Nintedanib 200mg | ||
| Total, other adverse events | Nintedanib 150mg | 6 | 7 |
| Total, other adverse events | Nintedanib 200mg | 12 | 12 |
| Total, serious adverse events | Nintedanib 150mg | 3 | 7 |
| Total, serious adverse events | Nintedanib 200mg | 4 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nintedanib 150mg vs Nintedanib 200mg: Dose Limiting Toxicities During Treatment Course 1 | Trial comparisons |
| Nintedanib 150mg vs Nintedanib 200mg: serious adverse events | Trial comparisons |
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/NCT01314105
GET https://conductscience.org/api/trials/v1/NCT01314105/results?page=2