LUME-Ovar 1: Nintedanib (BIBF 1120) or Placebo in Combination With Paclitaxel and Carboplatin in First Line Treatment of Ovarian Cancer

Phase 3

Completed

• Conditions: Ovarian Neoplasms; Peritoneal Neoplasms
• Interventions: Drug: BIBF 1120; Drug: Placebo; Drug: Paclitaxel; Drug: Carboplatin

• Registration Number: NCT01015118
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-09
• Study Start: 2009-11-17
• Study First Submitted QC: 2009-11-17
• Study First Posted: 2009-11-18
• Primary Completion: 2013-04-01
• Disposition First Submitted: 2014-03-27
• Disposition First Submitted QC: 2014-03-27
• Disposition First Posted: 2014-04-24
• Results First Submitted: 2014-11-14
• Results First Submitted QC: 2015-01-13
• Results First Posted: 2015-01-15
• Study Completion: 2016-09-15
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-03
• Last Update Posted: 2017-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1366

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIBF 1120	BIBF 1120	patients to receive BIBF 1120 standard dose twice daily PO in combination with combination with carboplatin and paclitaxel
Placebo	Placebo	patients to receive capsules identical to those containing BIBF 1120 in combination with combination with carboplatin and paclitaxel
BIBF 1120	Paclitaxel	patients to receive BIBF 1120 standard dose twice daily PO in combination with combination with carboplatin and paclitaxel
BIBF 1120	Carboplatin	patients to receive BIBF 1120 standard dose twice daily PO in combination with combination with carboplatin and paclitaxel
Placebo	Carboplatin	patients to receive capsules identical to those containing BIBF 1120 in combination with combination with carboplatin and paclitaxel
Placebo	Paclitaxel	patients to receive capsules identical to those containing BIBF 1120 in combination with combination with carboplatin and paclitaxel

Primary Outcome Measures

Name	Time	Method
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.
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 Outcome Measures

Name	Time	Method
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.
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.
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
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).
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.
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.
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).

Trial Locations

Locations (281)

1199.15.10113 Boehringer Ingelheim Investigational Site; 🇺🇸 Tucson, Arizona, United States

1199.15.10030 Boehringer Ingelheim Investigational Site; 🇺🇸 Long Beach, California, United States

1199.15.10001 Boehringer Ingelheim Investigational Site; 🇺🇸 Santa Rosa, California, United States

1199.15.10005 Boehringer Ingelheim Investigational Site; 🇺🇸 Englewood, Colorado, United States

1199.15.10028 Boehringer Ingelheim Investigational Site; 🇺🇸 New Haven, Connecticut, United States

1199.15.10014 Boehringer Ingelheim Investigational Site; 🇺🇸 Orlando, Florida, United States

1199.15.10010 Boehringer Ingelheim Investigational Site; 🇺🇸 Augusta, Georgia, United States

1199.15.10004 Boehringer Ingelheim Investigational Site; 🇺🇸 Savannah, Georgia, United States

1199.15.10011 Boehringer Ingelheim Investigational Site; 🇺🇸 Louisville, Kentucky, United States

1199.15.10003 Boehringer Ingelheim Investigational Site; 🇺🇸 Marrero, Louisiana, United States

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