The objectives of this trial are to estimate the following in Japanese patients with advanced NSCLC of stage IIIB/IV or with recurrence after failure of first-line chemotherapy. Phase I part The objective of the phase I part is to define the Maximum Tolerated Dose (MTD) of BIBF 1120 at a dose level up to twice daily 200 mg with standard dose of pemetrexed (500 mg/m\^2) and to determine the Recommended Dose (RD) for the phase II part. Phase II, to investigate the efficacy and safety of BIBF 1120 in combination with pemetrexed (500 mg/m\^2) as compared to pemetrexed (500 mg/m\^2) + placebo
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
19
BIBF 1120 medium dose bid+ Pemetrexed 500 mg/m\^2
BIBF 1120 high dose bid+ Pemetrexed 500 mg/m\^2
confirmed dose of BIBF 1120 bid + Pemetrexed 500 mg/m\^2
BIBF 1120 low dose bid+ Pemetrexed 500 mg/m\^2
placebo BIBF 1120 bid + Pemetrexed 500 mg/m\^2
1199.28.003 Boehringer Ingelheim Investigational Site
Chiba,Kashiwa, Japan
1199.28.002 Boehringer Ingelheim Investigational Site
Miyakojima-ku, Osaka, Japan
1199.28.001 Boehringer Ingelheim Investigational Site
Osaka-Sayama, Osaka, Japan
Dose Limiting Toxicities
Number of participants with dose limiting toxicity (DLT) in combination therapy of BIBF 1120 and pemetrexed during the first course
Time frame: During the first course, 21 days
Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 for All Courses
Number of patients with adverse events according to worst Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 for all courses. CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE) or 5 (death related to AE).
Time frame: Between first administration of pemetrexed and 28 days after last administration of pemetrexed and/or BIBF 1120, up to 1020 days
Overall Response Rate
Number of participants with complete response (CR) or partial response (PR) according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.0
Time frame: Every 6 weeks after start of study treatment until end of treatment, up to 992 days
Disease Control Rate
Number of participants with complete response (CR), partial response (PR) or stable disease (SD) according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.0
Time frame: Every 6 weeks after start of study treatment until end of treatment, up to 992 days
Duration of Disease Control
Duration of disease control was defined as the time period from the first study drug administration to the progressive disease (PD) or death of patients, whichever occurred earlier.
Time frame: From first study drug administration until PD or death, up to 1003 days
Number of Participants With Clinically Relevant Abnormalities in Laboratory Parameters
Number of participants with clinically relevant abnormalities in laboratory parameters reported as adverse events which occurred in \>= 20% of patients
Time frame: Between first administration of pemetrexed and 28 days after last administration of pemetrexed and/or BIBF 1120, up to 1020 days
AUC0-inf of Nintedanib
Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)
Time frame: 5 minutes (min) before nintedanib administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23h 55min after nintedanib administration in cycle 1
Cmax of Nintedanib
Maximum measured concentration of nintedanib in plasma (Cmax)
Time frame: 5 minutes (min) before nintedanib administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23h 55min after nintedanib administration in cycle 1
AUC0-inf of Pemetrexed
Area under the concentration-time curve of pemetrexed in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)
Time frame: 5 minutes (min) before pemetrexed administration and 10min, 40min, 1 hour (h), 2h, 4h, 6h, 23h 55min, 47h 55min after pemetrexed administration in cycles 1 and 2
Cmax of Pemetrexed
Maximum measured concentration of pemetrexed in plasma (Cmax)
Time frame: 5 minutes (min) before pemetrexed administration and 10min, 40min, 1 hour (h), 2h, 4h, 6h, 23h 55min, 47h 55min after pemetrexed administration in cycles 1 and 2
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