CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,366 enrolled
Drug / intervention
Placebo +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01015118
NCT01015118Phase 3Completed
CompareCT.gov

Multicenter, Randomised, Double-blind Phase III Trial to Investigate the Efficacy and Safety of BIBF 1120 in Combination With Carboplatin and Paclitaxel Compared to Placebo Plus Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer

Boehringer Ingelheim·interventional·Posted Nov 18, 2009·Updated Dec 7, 2017

In Brief

A Phase 3 clinical trial evaluating Placebo, Paclitaxel, and 2 other interventions for Ovarian Neoplasms and Peritoneal Neoplasms. Completed, enrolled 1,366 participants across 281 sites in 22 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Neoplasms, Peritoneal Neoplasms
CountriesAustralia, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Spain, Sweden, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 18, 2009
Enrollment StartNov 17, 2009
Primary CompletionApr 1, 2013
Study CompletionSep 15, 2016
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 16.6 years ago

Interventions

Placebodrug

comparator to BIBF 1120

Paclitaxeldrug

Paclitaxel (standard chemo-therapy)

BIBF 1120drug

comparison of BIBF 1120 in combination with chemotherapy and placebo in combination with chemotherapy (paclitaxel/carboplatin)

Carboplatindrug

Carboplatin (standard chemo-therapy)

Paclitaxeldrug

Paclitaxel (standard chemo-therapy)

Carboplatindrug

Carboplatin (standard chemo-therapy)