None listed
Conditions
Brief summary
This study is designed to compare the efficacy of sorafenib in combination with paclitaxel and carboplatin versus placebo in combination with paclitaxel and carboplatin for patients with NSCLC Stage IV or Stage IIIB with pleural or pericardial effusion. Treatments will be blinded to both the investigator and the patient. Double-blinding will be assured by having identical packaging of the sorafenib treatment and the placebo. An interactive voice response system will be used to accomplish allocation of treatment group.
Interventions
This is a randomized, double blind, placebo controlled, multicenter, Phase III study designed to compare the efficacy of sorafenib in combination with paclitaxel and carboplatin versus placebo in combination with paclitaxel and carboplatin for patients with NSCLC Stage IV or Stage IIIB with pleural or pericardial effusion.
The study population will include chemonaive patients with unresectable Stage IIIB (with pleural or pericardial effusion) or Stage IV NSCLC for whom treatment with paclitaxe
This is a randomized, double blind, placebo controlled, multicenter, Phase III study designed to compare the efficacy of sorafenib in combination with paclitaxel and carboplatin versus placebo in combination with paclitaxel and carboplatin for patients with NSCLC Stage IV or Stage IIIB with pleural or pericardial effusion. The study population will include chemonaive patients with unresectable Stage IIIB (with pleural or pericardial effusion) or Stage IV NSCLC for whom treatment with paclitaxel and carboplatin is considered medically acceptable. Patients will be randomized in a double-blind fashion using a 1:1 allocation of patients to sorafenib in combination with paclitaxel and carboplatin (sorafenib group) or placebo in combination with paclitaxel and carboplatin (placebo group). Patients will receive up to 6 cycles (21 day cycles) of paclitaxel (200 mg/m2 IV on Day 1, based on body weight) and carboplatin (AUC 6 IV on Day 1, based on body weight) in combination with either sorafenib (800 mg orally twice daily) or placebo.
Sponsors
Bayer Australia Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Stage IIIB (with cytologically confirmed malignant pleural or pericardial effusion) or Stage IV histological or cytological confirmation of NSCLC.No prior chemotherapy.Prior local radiotherapy is allowed if it is completed at least 3 weeks prior to the first dose of study drug.Prior surgery is allowed if it is performed at least 4 weeks prior to the first dose of study drug. Performance status (Eastern Cooperative Group) of 0 or 1. Life expectancy of at least 12 weeks.Adequate bone marrow, liver and renal function.Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men should use adequate birth control for at least three months after the last administration of sorafenib. Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures.
Exclusion criteria
Any prior systemic anticancer therapy including cytotoxic therapy, targeted agents, experimental therapy, adjuvant, or neo-adjuvant therapy for NSCLC.Cardiac disease: Congestive heart failure > class II New York Heart Association. Patients must not have unstable angina (anginal symptoms at rest) or new-onset angina (began within the last 3 months) or myocardial infarction within the past 6 months Known brain metastasis. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy. Uncontrolled hypertension. Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C. Active clinically serious infections. Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months. Pulmonary hemorrhage/bleeding event within 4 weeks of first dose of study drug. Any other hemorrhage/bleeding event within 4 weeks of first dose of study drug.Serious, non-healing wound, ulcer, or bone fracture.Evidence or history of bleeding diathesis or coagulopathy.Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug.Therapeutic anticoagulation with vitamin K antagonists.Use of St John’s Wort or rifampin (rifampicin).Known or suspected allergy to sorafenib or any agent given in the course of this trial. Previous cancer that is distinct in primary site or histology from NSCLC, EXCEPT cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumors or any cancer curatively treated less than 3 years prior to study entry.Concurrent cancer that is distinct in primary site or histology from NSCLC.Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results.Any condition that impairs patient’s ability to swallow whole pills. Any malabsorption condition.
Outcome results
None listed