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To confirm the safety of BIBF 1120 at a dose level up to 200 mg x 2/day (i.e., overseas recommended Phase III dose for combination treatment) with standard therapy of docetaxel (60 mg/m2 and 75 mg/m2) in Japanese advanced non small cell lung cancer (NSCLC) patients with stage IIIB/IV or recurrent after failure of first line chemotherapy and to determine the recommended dose for the Phase II trial.
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Inclusion criteria
Histologically/cytologically confirmed, locally advanced/metastatic NSCLC of stage IIIB/IV or recurrent NSCLC (all histologies. Existence or nonexistence of measurable lesion according to RECIST is no object.)
Patients with one prior chemotherapy regimen including platinum-containing drug.
In case of recurrent disease, one additional prior regimen is allowed for adjuvant and/or neoadjuvant therapy. However monotherapy of EGFR-TKI (i.e. erlotinib/Tarceva® and gefitinib/Iressa®) is not counted as 'one regimen'.
Male or female patients age >=20 years and =<74 years at the enrolment.
Life expectancy of at least three (3) months after the start of administration of the investigational drug.
Eastern Cooperative Oncology Group (ECOG) [R01-0787] performance Score 0 or 1.
Patients retaining a significant physiological compensatory function and patients with sufficient baseline organ function as follows:
Written informed consent that is consistent with ICH-GCP guidelines.
Exclusion criteria
Primary purpose
Allocation
Interventional model
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43 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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