18 and older, female only, with Ovarian Neoplasms or Peritoneal Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria.Primary· First drug administration to date of disease progression or death whichever occurs first , upto 29 months
Progression free survival (PFS) is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first according to the Investigator assessment.
The primary PFS analysis of this trial was performed when approximately 753 patients had experienced a PFS event
Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.
Group
Value
95% CI
Nintedanib
17.2
11.1 – 32.5
Placebo
16.6
10.8 – 30.4
PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria (Follow up Analysis).Primary· First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months
Follow-up analysis was conducted at the time of overall survival analysis. Progression free survival (PFS) is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first according to the Investigator assessment.
Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.
Group
Value
95% CI
Nintedanib
17.6
11.1 – 38.0
Placebo
16.6
10.8 – 37.3
PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint).Secondary· First drug administration to date of disease progression or death whichever occurs first , upto 29 months
Progression free survival is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first based on the Investigator assessment according to Modified Response Evaluation Criteria (mRECIST), version 1.1.
The primary PFS analysis of this trial was performed when approximately 753 patients had experienced a PFS event.
Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.
Group
Value
95% CI
Nintedanib
18.3
11.1 – 32.5
Placebo
16.6
10.8 – 30.4
PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint - Follow up Analysis).Secondary· First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months
Follow-up analysis was conducted at the time of overall survival analysis. Progression free survival is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first based on the Investigator assessment according to Modified Response Evaluation Criteria (mRECIST), version 1.1. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.
Group
Value
95% CI
Nintedanib
18.4
11.1 – 38.5
Placebo
16.6
10.8 – 37.3
Overall SurvivalSecondary· First drug administration to date of death until final DBL 26September16, upto 62 months
Overall survival is defined as time from randomization to date of death (irrespective of reason).
Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.
Group
Value
95% CI
Nintedanib
62.0
30.0 – NA
Placebo
62.8
30.6 – NA
Time to CA-125 Tumour Marker ProgressionSecondary· First drug administration until final DBL 26September16, upto 62 months
Time to tumour-marker progression was defined as the time from randomisation until the date when Carbohydrate (cancer) antigen (CA-125) values increased to higher than twice the nadir value. CA-125 \>=2 x nadir in case nadir value \> Upper limit of normal (ULN) or CA-125 \>=2 x ULN in case nadir value \<= ULN.
Group
Value
95% CI
Nintedanib
16.6
10.6 – 47.0
Placebo
14.1
8.6 – 42.6
Objective Response Based on Investigator AssessmentSecondary· First drug administration until final DBL 26September16, upto 62 months
Objective tumour response defined as either complete response \[CR\] or partial response \[PR\] in patients with at least 1 target lesion reported at baseline
Group
Value
95% CI
Nintedanib
74.3
Placebo
70.2
Change in Abdominal/Gastro-intestinal Symptoms Over TimeSecondary· First drug administration until final DBL 26September16, upto 62 months
Change in abdominal/gastro-intestinal over time was calculated on symptoms (scale composite of items 31 to 37 of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Module for Ovarian Cancer 28 (EORTC QLQ OV-28).
As specified in the EORTC scoring manual, for each scale or item, a linear transformation was applied to standardize the raw score to a range from 0 to 100 (high scores represent a high/severe level of symptomatology).
Mean presented is Adjusted mean. Adjusted for the stratification factors macroscopic residual postoperative tumour at baselin
Group
Value
95% CI
Nintedanib
24.63
± 0.49
Placebo
19.34
± 0.64
Change in Global Health Status/ Quality of Life (QoL) Scale Over Time.Secondary· First drug administration until final DBL 26September16, upto 62 months
Change in Global Health Status/ Quality of life (QoL) over time was calculated on Global Health Status/QoL scale (composite of items 29 and 30 of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-C30) as a general measure.
As specified in the EORTC scoring manual, for each scale or item, a linear transformation was applied to standardize the raw score to a range from 0 to 100 (high scores represent a high/healthy level of functioning).
Mean presented is Adjusted mean. Adjusted for the stratification factors macroscopic residual postope
Group
Value
95% CI
Nintedanib
68.79
± 0.48
Placebo
70.67
± 0.65
Adverse events — posted to ClinicalTrials.gov
Time frame: First drug administration until data cut-off 26September16, up to 62 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Placebo
Serious: 157/450 (35%)
Deaths: —
Nintedanib
Serious: 379/902 (42%)
Deaths: —
Serious adverse events (376 terms)
Reaction
System
Placebo
Nintedanib
Diarrhoea
Gastrointestinal disorders
—
—
Anaemia
Blood and lymphatic system disorders
—
—
Vomiting
Gastrointestinal disorders
—
—
Abdominal pain
Gastrointestinal disorders
—
—
Neutropenia
Blood and lymphatic system disorders
—
—
Nausea
Gastrointestinal disorders
—
—
Pyrexia
General disorders
—
—
Thrombocytopenia
Blood and lymphatic system disorders
—
—
Dehydration
Metabolism and nutrition disorders
—
—
Febrile neutropenia
Blood and lymphatic system disorders
—
—
Ileus
Gastrointestinal disorders
—
—
General physical health deterioration
General disorders
—
—
Urinary tract infection
Infections and infestations
—
—
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The trial will be performed to evaluate if BIBF 1120 in combination with paclitaxel and carboplatin is more effective than placebo in combination with paclitaxel and carboplatin in first-line treatment of patients with advanced ovarian cancer. Safety information about BIBF1120/paclitaxel/carboplatin will be obtained.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 7 December 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01015118.