None listed
Conditions
Interventions
Group 1 Type of group
Standard dose of pemetrexed (500 mg / m2 intravenously) on Day 1 with BIBF 1120 (200 mg orally, twice daily) on Days 2-21 of each 3-week cycle.
Group name:Group 2 Type of group
Standard dose of pemetrexed on Day 1 Along with placebo twice a day on Days 2-21 of each 21-day cycle. Patients will receive prior and concomitant medication appropriate for the administration of pemetrexed.
Sponsors
Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI),
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: • Male or female patients 18 years of age or older • Histologically or cytologically confirmed NSCLC, stage IIIB / IV (according to AJCC) or recurrent (non-epidermoid histologies) • Relapse or failure of a first-line chemotherapy (in the case of recurrent disease, an additional prior regimen is allowed as an adjuvant, neoadjuvant or neoadjuvant therapy together with adjuvant therapy) • At least one white tumor lesion that has not been irradiated within the last three months and that can be accurately measured by magnetic resonance imaging (MRI) or computed tomography (CT) in at least one dimension (the maximum diameter should be recorded) that either> 20 mm with conventional techniques or> 10 mm with helical CT • Life expectancy of at least three months • ECOG score 0 or 1 • The patient must provide written informed consent, which must be consistent with the Good Clinical Practice of the International Conference on Harmonization (ICH-GCP) and local legislation
Exclusion criteria
Exclusion criteria: • Previous therapy with other vascular endothelial growth factor (VEGF) inhibitors (other than bevacizumab) or pemetrexed for treatment of NSCLC • Treatment with other investigational drugs or treatment in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial • Chemotherapy, hormone therapy, immunotherapy with monoclonal antibodies, treatment with tyrosine kinase inhibitors, or radiotherapy (except for treatment of extremities) within the past four weeks prior to treatment with the trial drug, i.e., the minimum time elapsed since the last anticancer therapy and the first administration of BIBF 1120 must be four weeks • Inability to stop intake of NSAIDS (non steroidal anti inflammatory drugs) for several days • Active brain metastases (e.g. stable for 10 %) within the past 6 weeks prior to treatment in the present trial • Current peripheral neuropathy greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 except due to trauma • Pre-existing ascites (abdominal fluid collection) and/or clinically significant pleural effusion ( fluid collection between the lung and chest wall) • Major injuries and/or surgery within the past ten days prior to start of study drug • Incomplete wound healing • Active or chronic hepatitis C and/or B infection Additional exclusion criteria apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria. Progression free survival (PFS) is defined as the duration of time from date of randomisation to date of progression or death (whatever occurs earlier). Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. Measure:Progression Free Survival (PFS) as Assessed by Central Independent Review Timepoints:From randomisation until cut-off date 9 July 2012 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Overall Survival (OS) defined as the duration from randomisation to death (irrespective of the reason of death). Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. Measure:Overall Survival Timepoints:From randomisation until data cut-off (15 February 2013), Up to 30 months ; Outcome name:Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. Measure:Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review Timepoints:From randomisation until data cut-off (15 February 2013), Up to 30 months ; Outcome name:Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by investigator according to the modified RECIST (version 1.0) criteria. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. Measure:Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Investigator Timepoints:From randomisation until data cut-off (15 February 2013), Up to 30 months ; Outcome name:Confirmed objective response is defined as confirmed Complete Response (CR) and Partial Response (PR) and evaluated according to the modified RECIST criteria version 1.0. This endpoint was analysed based on the central independent reviewer as well as the investigator Measure:Objective Tumor Response Timepoints:From randomisation until data cut-off (15 February 2013), Up to 30 months ; Outcome name:The duration of objective response is the time from first documented (CR) or (PR) to the time of progression or death and evaluated according to the modified RECIST criteria version 1.0. Median, 25th and 75th percentiles are cal | — |
Countries
Argentina, Australia, Belarus, Brazil, Bulgaria, Canada, Chile, Croatia, Ecuador, Germany, Hungary, India, Ireland, Israel, Korea South, Latovia, Macedonia, Malasya, Mexico, Modalvia, Netherlands, New Zealand, Poland, Romania, Russian Federation, Serbia, Singapore, South Africa, Sweden, Taiwan, Thailand, Turkey, Ukraine, United States
Contacts
Public ContactYngrid Rossana Saldarriaga
PAREXEL INTERNATIONAL (PERU) S.A.
Outcome results
None listed