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NCT01015118 · ClinicalTrials.gov registry record · Phase 3
LUME-Ovar 1: Nintedanib (BIBF 1120) or Placebo in Combination With Paclitaxel and Carboplatin in First Line Treatment of Ovarian Cancer
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,366
- Enrollment target
NCT01015118: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01015118 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 1,366 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01015118, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,366 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- DRUG Carboplatin
- DRUG Placebo
- DRUG Paclitaxel
- DRUG BIBF 1120
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,366 participants |
| Start Date | 2009-11-17 |
| Est. Completion | 2016-09-15 |
| Phase | Phase 3 |
What the finished NCT01015118 record still lists
NCT01015118 is an interventional study that assigns participants to a tested intervention. Its 1,366 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% higher).
The record links to 0 conditions, and to 4 interventions - of which Carboplatin is the first listed.
NCT01015118 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01015118 about?
NCT01015118 is a clinical study titled "LUME-Ovar 1: Nintedanib (BIBF 1120) or Placebo in Combination With Paclitaxel and Carboplatin in First Line Treatment of Ovarian Cancer". 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...
What is the current status of trial NCT01015118?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,366 participants. The study started on 2009-11-17. Estimated completion is 2016-09-15.
What interventions are being tested in trial NCT01015118?
The interventions under investigation include: Carboplatin (DRUG), Placebo (DRUG), Paclitaxel (DRUG), BIBF 1120 (DRUG).
Who is sponsoring clinical trial NCT01015118?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01015118's enrollment target sits among peer trials
1,366 180th of 2000 higher than 1,821 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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