None listed
Conditions
Interventions
Group 1 Type of group
Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
Group name:Group 2 Type of group
Participants received 2 tablets of placebo orally twice daily (BID)
Sponsors
BAYER HEALTHCARE AG,
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Ability to understand and willingness to sign a written Informed Consent. A signed Informed Consent must be obtained prior to performing any study specific procedures. • Advanced relapsed or refractory predominantly non squamous NSCLC. The diagnosis must have been confirmed cyto-/ histologically (documentation of original cytology/ biopsy result is acceptable). • Patients must have measurable or non-measurable disease as defined in Section 4.6.4.2. All sites of disease must be evaluated within 4 weeks prior to first dose of study medication. • At least two but not more than three prior standard treatment regimens for NSCLC • ECOG Performance Status of 0 or 1 • Life expectancy of at least 12 weeks • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment (assessed centrally) • Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and 4 weeks after the completion of trial • Adequate bone marrow, liver and renal function
Exclusion criteria
Exclusion criteria: • NSCLC patients with predominantly squamous cell carcinoma histology • History of cardiac disease • History of HIV infection or chronic hepatitis B or C • History of organ allograft • Active clinically serious infections (> grade 2 NCI-CTCAE vers. 3.0) • Patients with seizure disorder requiring medication (Patients who experienced seizures due to brain metastases prior to radical treatment of these metastases are allowed if the inclusion criterion related to brain metastases is adhered to - see section 4.2.1, inclusion criteria, for details). • Patients with evidence or history of bleeding diathesis or coagulopathy • Patients undergoing renal dialysis • Pulmonary hemorrhage/ bleeding event = CTCAE grade 2 within four weeks of the first dose of the study drug • Any other hemorrhage/ bleeding event = CTCAE grade 3 within four weeks of the first dose of the study drug • Non-healing wound, ulcer or bone fracture • Thrombotic or embolic venous or arterial events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months prior to the first dose of study drug • Previous or concurrent cancer that is distinct in primary site or histology from NSCLC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis, T1). Any cancer curatively treated >3 years prior to entry is permitted. • Known or suspected allergy or any other contraindication for sorafenib administration • Pregnant or breast-feeding women. [Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and during the first four weeks after the completion of trial].
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Overall survival (OS) was defined as the time from date of randomization to date of death due to any cause. Overall survival of subjects alive at the time of analysis will be censored at their last date of follow-up or database cut off date whichever came first. Measure:Overall Survival Timepoints:From randomization of the first subject until 36 months later | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Progression-free survival (PFS) was defined as the time from date of randomization to date of first observed disease progression (radiological or clinical, whichever is earlier) or death due to any cause, if death occurs before progression is documented. Progressive Disease (PD) is defined as at least a 20% increase in the sum of longest diameter (LD) of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Appearance of new lesions will also constitute progressive disease. In exceptional circumstances unequivocal progression of a non-measured lesion may be accepted as evidence of disease progression. Measure:Progression-free Survival Timepoints:From randomization of the first subject until 36 months later assessed every 6 weeks ; Outcome name:Disease control (DC) was defined as the proportion of patients whose best response was Complete Response [CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target)] or Partial Response [PR: at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD] or Stable Disease [SD: steady state of disease which was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD)]. Measure:Disease Control Timepoints:From randomization of the first subject until 36 months later assessed every 6 weeks ; Outcome name:Objective tumor response was defined as the proportion of patients whose best response was Complete Response [CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target)] or Partial Response [PR: at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD] over the whole duration of study. Measure:Objective Tumor Response Timepoints:From randomization o | — |
Countries
Austria, Bulgaria, France, Germany, Greece, Hungaria, Italy, Netherlands, Peru, Spain, Sweden, United Kindgdom
Contacts
Public ContactLuis Carlos Razzeto
BAYER S.A.
Outcome results
None listed