This is a phase II/III confirmatory study designed to evaluate the safety and efficacy of nintedanib (BIBF 1120) in combination + (pemetrexed / cisplatin) followed by nintedanib (BIBF 1120) versus placebo + pemetrexed / cisplatin followed by placebo for the treatment of patients with unresectable malignant pleural mesothelioma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
545
triple kinase inhibitor; 200mg starting dose
backbone chemo
backbone chemo
Progression-Free Survival (PFS)
This outcome measure presents progression-free survival. Disease progression was defined according to the modified Response Evaluation Criteria in Solid Tumours (RECIST) criteria. Progression-free survival time was calculated as the duration from the date of randomization to the date of disease progression or death, whichever occurred first. For patients with known date of progression (or death): PFS (days) = min (date of progression, date of death) - date of randomization + 1 day. For patients without progression or death, PFS was censored at the last imaging date that showed no disease progression: PFS (days, censored) = date of last imaging showing no progression - date randomization + 1 day.
Time frame: From randomization until the earliest of disease progression, death or (Phase II: cut-off date of 4-March-2016; up to 889 days) (Phase III: cut-off date of 16-March-2018; up to 31 months)
Overall Survival (OS)
Overall survival was defined as the duration of time from randomization to time of death. This is the key secondary endpoint of the trial.
Time frame: From randomization until the earliest of disease progression, death or (Phase II: cut-off date of 4-March-2016; up to 889 days) (Phase III: cut-off date of 16-March-2018; up to 31 months)
Objective Response According to Modified RECIST- Investigator Assessment
Objective response (best overall tumour response of confirmed complete response \[CR\] or confirmed partial response \[PR\]). Complete Response: disappearance of all target lesions Partial Response: at least a 30 % decrease in the total tumour measurement of target lesions, taking as reference the baseline total tumour measurement. Percentage of Patients with confirmed objective response is presented. This endpoint was only evaluated for Phase III part.
Time frame: Tumour imaging was to be performed every 6 weeks until disease progression, death or start of subsequent anti-cancer therapy, whichever occurred earlier; up to 54 months
Disease Control According to Modified RECIST- Investigator Assessment
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backbone chemo
backbone chemo
Nintedanib matching placebo
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California San Francisco
San Francisco, California, United States
Rocky Mountain Cancer Centers
Littleton, Colorado, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Greenville Health System
Greenville, South Carolina, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Texas Oncology - McAllen
McAllen, Texas, United States
Texas Oncology-San Antonio Northeast
San Antonio, Texas, United States
Cancer Care Northwest Centers, PS
Spokane Valley, Washington, United States
...and 113 more locations
Disease control (best overall response of confirmed CR or PR, or Stable Disease (SD) that lasted ≥36 days) according to modified RECIST. Percentage of Patients with Disease control is presented. This endpoint was only evaluated for Phase III part.
Time frame: Tumour imaging was to be performed every 6 weeks until disease progression, death or start of subsequent anti-cancer therapy, whichever occurred earlier; up to 54 months