Patients with advanced non small cell lung cancer that harbours a K-Ras mutation
Conditions
Interventions
Trade Name: Nexavar
Product Name: nexavar
Product Code: LO1XE05
Pharmaceutical Form: Tablet
INN or Proposed INN: SORAFENIB
CAS Number: 284461-73-0
Sponsors
VU University Medical
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically advanced NSCLC stage IIIB or IV harbouring a K-RAS mutation 2. Disease progression after at least 1 prior chemotherapy regimen that should include a platinum doublet 3. Prior surgery and/or localized irradiation is permitted provided that the irradiated lesion is not the only measurable lesion. 4. Age > 18 years. 5. ECOG Performance Status of 0-2 6. Life expectancy of at least 12 weeks 7. written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 64 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 64
Exclusion criteria
Exclusion criteria: 1. History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arythmias requiring anti-arythmic therapy( beta blockers or digoxin are permitted) or uncontrolled hypertension. 2. History of HIV infection or chronic hepatitis B or C. 3. Active clinically serious infections (> grade 2 NCI-CTC version 3.0) 4. Symptomatic metastatic brain or meningeal tumors (unless the patient is > 1 months from definitive radiotherapy and off steroids): 5. Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: duration of response • time to disease progression or death • survival;Primary end point(s): The main endpoint of the study is the rate of no progression at 6 weeks (NPR). This NPR is defined as the rate of subjects without progression (based on RECIST criteria) at 6 weeks after start of treatment;Timepoint(s) of evaluation of this end point: 6 weeks after start treatment;Main Objective: Efficacy of sorafenib and metformin in NSCLC with a K-RAS mutation as determined by the Rate of No Progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: after completing study;Secondary end point(s): 6.2.1 Response rate, Disease Control Rate and Response Duration Each subject will be assigned a best objective response. This is defined as the best response recorded from the start of treatment until disease progression/recurrence (according to RECIST criteria). To be assigned the status of PR or CR, changes in tumour measurements must be confirmed by repeated assessments that should be performed no less than 4 weeks after the criteria for response are first met. The Disease Control Rate is defined as the number of CR+PR+SD patients. Objective response will be summarized in a descriptive manner. The analysis of duration of tumour response will be based on responding patients. Duration of response is defined as the time from first response to the time of documented disease progression or death (assuming confirmation of response at least 4 weeks after initial documentation). Subjects still responding to treatment at the time of analysis will be treated as censored observations for duration of response on the date of the last tumour assessment. 6.2.2 Progression Free survival Progression free survival is defined as the time from date of informed consent 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. The actual date of tumour assessments will be used for this calculation. PFS for patients without disease progression or death at the time of analysis will be censored at the last date of tumour evaluation. PFS for patients who have no tumour assessments after baseline will be censored at day 1. 6.2.3 Overall Survival Overall survival will be determined from the date of start of treatment to the date of death irrespective of the cause of death. Patients who have not died at the time of the final analysis will be censored at the date of last contact. | — |
Countries
Netherlands
Contacts
Public ContactProf. dr. E.F. Smit
VU University Medical Center
Outcome results
None listed