1、This study has been completed. Sponsor: Hoffmann-La Roche Information provided by (Responsible Party): Hoffmann-La Roche ClinicalTrials.gov Identifier: NCT00976911 First received: September 14, 2009 Last updated: February 24, 2015 Last verified: February 2015 History of Changes Full Text View Tabula
2、r View Study Results Disclaimer How to Read a Study Record A service of the U.S. National Institutes of Health AURELIA: A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients With Platinum-resistant Ovarian Cancer Results First Received: December 3, 2014 Study Type: Interventional Study
3、Design: Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment Condition: Ovarian Cancer Interventions: Drug: bevacizumab Avastin Drug: liposomal doxorubicin Drug: paclitaxel Drug: topotecanPart
4、icipant FlowHide Participant Flow Recruitment Details Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations No text entered. Pre-Assignment Details Significant events and approaches for the overall study following participant
5、 enrollment, but prior to group assignment No text entered. Reporting Groups Description Chemotherapy Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 milligrams per square meter (mg/m2) as a 1-hour intravenous (IV) infusion on Days 1, 8
6、, 15, and 22 every 4 weeks (q4w) OR topotecan 4 mg/m2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m2 dose could have been administered over 30 minutes on Days 1-5 every 3 weeks q3w) OR pegylated liposomal doxorubicin (PLD) 40 mg/m2 as a 1 milligram per minute (mg/mi
7、n) infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. Chemotherapy + Bevacizumab Participants received one of the following chemotherapies at the discretion o
8、f the investigator: paclitaxel, 80 mg/m2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m2 as a 1 mg/min infusio
9、n on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion. Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 milligrams per kilogram (mg/kg) IV every 2 weeks (q2w; or
10、bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated. Participant Flow: Overall StudyChemotherapy Chemotherapy + Beva
11、cizumab 1/7 AURELIA: A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients W. 2015-10-8 https:/www.clinicaltrials.gov/ct2/show/results/NCT00976911?sect=X870156 Data Cutoff 14 November 2011) Time Frame: Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression
12、reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011 Hide Outcome Measure 2 Measure Type Primary Measure Title Progression Free Survival (PFS; Data Cutoff 14 November 2011) Measure Description PFS was defined as the time from the date of random
13、ization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigators according to the RECIST criteria (for participants with measurable disease), and for those with non-measurable disease presence or 3/7 AURELIA:
14、A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients W. 2015-10-8 https:/www.clinicaltrials.gov/ct2/show/results/NCT00976911?sect=X870156 only participants with an event of progression or death were included in the analysis Reporting Groups Description Chemotherapy Participants receive
15、d one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m2 dose could have been administered over 30 minut
16、es on Days 1-5 q3w) OR PLD 40 mg/m2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. Chemotherapy + Bevacizumab Participants received one of t
17、he following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m2 dose could have been administered over 30 minutes on Days
18、 1-5 q3w) OR PLD 40 mg/m2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q
19、2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated. Measured ValuesChemotherapy Chemotherapy + Bevacizumab N
20、umber of Participants Analyzed units: participants168 141 Progression Free Survival (PFS; Data Cutoff 14 November 2011) units: months Median (95% Confidence Interval) 3.4 (2.10 to 3.75) 6.7 (5.62 to 7.79) Statistical Analysis 1 for Progression Free Survival (PFS; Data Cutoff 14 November 2011) Groups
21、 1 All groups Method 2 Log Rank P Value 3 0.0001 Hazard Ratio (HR) 4 0.379 95% Confidence Interval 0.296 to 0.485 1 Additional details about the analysis, such as null hypothesis and power calculation: No text entered. 2 Other relevant method information, such as adjustments or degrees of freedom: N
22、o text entered. 3 Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance: No text entered. 4 Other relevant estimation information: 4/7 AURELIA: A Study of Avastin (Bevacizumab) Added to Chemotherapy in
23、Patients W. 2015-10-8 https:/www.clinicaltrials.gov/ct2/show/results/NCT00976911?sect=X870156 Data Cutoff 14 November 2011) Groups 1 All groups Method 2 Log Rank P Value 3 0.0001 Hazard Ratio (HR) 4 0.460 95% Confidence Interval 0.366 to 0.577 1 Additional details about the analysis, such as null hy
24、pothesis and power calculation: No text entered. 2 Other relevant method information, such as adjustments or degrees of freedom: Unstratified analysis 3 Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical signific
25、ance: No text entered. 4 Other relevant estimation information: No text entered. Statistical Analysis 3 for Progression Free Survival (PFS; Data Cutoff 14 November 2011) Groups 1 All groups Method 2 Peto-Peto-Prentice P Value 3 0.0001 1 Additional details about the analysis, such as null hypothesis
26、and power calculation: No text entered. 2 Other relevant method information, such as adjustments or degrees of freedom: Unstratified analysis 3 Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance: No
27、text entered. Statistical Analysis 4 for Progression Free Survival (PFS; Data Cutoff 14 November 2011) Groups 1 All groups Method 2 Peto-Peto-Prentice P Value 3 0.0001 1 Additional details about the analysis, such as null hypothesis and power calculation: No text entered. 2 Other relevant method inf
28、ormation, such as adjustments or degrees of freedom: Stratified analysis:Strata were chemotherapy selected, prior anti-angiogenic therapy, and platinum-free interval. 3 Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for stat
29、istical significance: No text entered. 3. Secondary: Percentage of Participants With Best Overall Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) Per Modified RECIST (Data Cutoff 14 November 2011) Time Frame: Screening Visit, Every 8 weeks (or 9 weeks if receiving 5/7 AURELIA: A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients W. 2015-10-8 https:/www.clinicaltrials.gov/ct2/show/results/NCT00976911?sect=X870156&term=b.
