Trial · NCT01015118
LUME-Ovar 1: Nintedanib (BIBF 1120) or Placebo in Combination With Paclitaxel and Carboplatin in First Line Treatment of Ovarian Cancer
NCT01015118, Phase 3, Completed, Boehringer Ingelheim; results first posted 2015-01-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. LUME-Ovar 1: Nintedanib (BIBF 1120) or Placebo in Combination With Paclitaxel and Carboplatin in First Line Treatment of Ovarian Cancer. Trials, record NCT01015118. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01015118
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- LUME-Ovar 1: Nintedanib (BIBF 1120) or Placebo in Combination With Paclitaxel and Carboplatin in First Line Treatment of Ovarian Cancer
- NCT number
- NCT01015118
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,366 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Ovarian Neoplasms, Peritoneal Neoplasms
- Interventions
- Placebo, Paclitaxel, BIBF 1120, Carboplatin, Paclitaxel, Carboplatin
- First posted
- 2009-11-18
- Last updated
- 2017-12-07
- Other registries' IDs
- eudract:2008-006831-10
- Results first posted
- 2015-01-15
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria. | 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. |
| Primary | 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). | 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. |
| Secondary | PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint). | 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. |
| Secondary | PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint - Follow up Analysis). | 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. |
| Secondary | Overall Survival | 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. |
| Secondary | Time to CA-125 Tumour Marker Progression | 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. |
| Secondary | Objective Response Based on Investigator Assessment | 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 |
| Secondary | Change in Abdominal/Gastro-intestinal Symptoms Over Time | 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 baseline (yes vs. no), FIGO stage (IIB-III vs IV), and Carboplatin level (AUC5 vs. AUC6). |
| Secondary | Change in Global Health Status/ Quality of Life (QoL) Scale Over Time. | 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 postoperative tumour at baseline (yes vs. no), FIGO stage (IIB-III vs IV), and Carboplatin level (AUC5 vs. AUC6). |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria. | First drug administration to date of disease progression or death whichever occurs first , upto 29 months | Randomised Set (RS) | Months | MEDIAN |
| PRIMARY | 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). | First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months | Randomised Set (RS) | Months | MEDIAN |
| SECONDARY | PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint). | First drug administration to date of disease progression or death whichever occurs first , upto 29 months | Randomised Set (RS) | Months | MEDIAN |
| SECONDARY | PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint - Follow up Analysis). | First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months | Randomised Set (RS) | Months | MEDIAN |
| SECONDARY | Overall Survival | First drug administration to date of death until final DBL 26September16, upto 62 months | Randomised Set (RS) | Months | MEDIAN |
| SECONDARY | Time to CA-125 Tumour Marker Progression | First drug administration until final DBL 26September16, upto 62 months | Randomised set (RS) | Months | MEDIAN |
| SECONDARY | Objective Response Based on Investigator Assessment | First drug administration until final DBL 26September16, upto 62 months | Randomised Set (RS) for patients with at least 1 target lesion reported at baseline | percentage of participants | NUMBER |
| SECONDARY | Change in Abdominal/Gastro-intestinal Symptoms Over Time | First drug administration until final DBL 26September16, upto 62 months | Randomised Set (RS) for patients with abdominal/gastro-intestinal symptoms | units on a scale | MEAN |
| SECONDARY | Change in Global Health Status/ Quality of Life (QoL) Scale Over Time. | First drug administration until final DBL 26September16, upto 62 months | Randomised Set (RS) for patients with global health status/QoL | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria. | Nintedanib | 17.2 | Inter-Quartile Range 11.1 to 32.5 | Months | |
| PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria. | Placebo | 16.6 | Inter-Quartile Range 10.8 to 30.4 | Months | |
| 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). | Nintedanib | 17.6 | Inter-Quartile Range 11.1 to 38.0 | Months | |
| 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). | Placebo | 16.6 | Inter-Quartile Range 10.8 to 37.3 | Months | |
| PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint). | Nintedanib | 18.3 | Inter-Quartile Range 11.1 to 32.5 | Months | |
| PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint). | Placebo | 16.6 | Inter-Quartile Range 10.8 to 30.4 | Months | |
| PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint - Follow up Analysis). | Nintedanib | 18.4 | Inter-Quartile Range 11.1 to 38.5 | Months | |
| PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint - Follow up Analysis). | Placebo | 16.6 | Inter-Quartile Range 10.8 to 37.3 | Months | |
| Overall Survival | Nintedanib | 62.0 | Inter-Quartile Range 30.0 to NA | Months | |
| Overall Survival | Placebo | 62.8 | Inter-Quartile Range 30.6 to NA | Months |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 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 | 911 | |
| Overall Study | STARTED | Placebo | 455 | |
| Overall Study | COMPLETED | Nintedanib | 242 | |
| Overall Study | COMPLETED | Placebo | 128 | |
| Overall Study | NOT COMPLETED | Nintedanib | 669 | |
| Overall Study | NOT COMPLETED | Placebo | 327 |
Source ClinicalTrials.gov
Adverse events868
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 | Placebo | 129 | 450 | |
| other | Anaemia | Blood and lymphatic system disorders | Nintedanib | 317 | 902 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo | 78 | 450 | |
| other | Leukopenia | Blood and lymphatic system disorders | Nintedanib | 165 | 902 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo | 203 | 450 | |
| other | Neutropenia | Blood and lymphatic system disorders | Nintedanib | 419 | 902 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo | 87 | 450 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Nintedanib | 301 | 902 | |
| other | Abdominal distension | Gastrointestinal disorders | Placebo | 20 | 450 | |
| other | Abdominal distension | Gastrointestinal disorders | Nintedanib | 55 | 902 |
1 to 10 of 868Source ClinicalTrials.gov
See all 868 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Nintedanib | ||
| Total, other adverse events | Placebo | 442 | 450 |
| Total, other adverse events | Nintedanib | 891 | 902 |
| Total, serious adverse events | Placebo | 157 | 450 |
| Total, serious adverse events | Nintedanib | 379 | 902 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Nintedanib vs Placebo: serious adverse events |
Source 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/NCT01015118
GET https://conductscience.org/api/trials/v1/NCT01015118/events?page=2