Study of Nexavar (Sorafenib, BAY 43-9006) in Patients With Advanced Refractory Cancer

Bayer

Status and phase

Completed

Phase 2

Conditions

Carcinoma, Renal Cell

Treatments

Drug: Placebo

Drug: Sorafenib (Nexavar, BAY43-9006)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00079612

100391

Details and patient eligibility

About

The purpose of the study is to:

Find out if BAY 43-9006 prevents the growth of tumors
For patients who have stable cancer status after 3 months of treatment if it is safer and/or more effective to continue to give BAY 43-9006 or to stop giving BAY 43-9006 at that time.
Find out how long the effect of BAY 43-9006 is on tumors. To assess the safety of BAY 43-9006 (sorafenib) in the treatment of advanced refractory cancers.
Measure the amount of BAY 43-9006 and some of its targets in the blood stream in some patients.

Enrollment

501 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age > 18 years- Patients with refractory solid cancer for which curative or palliative measures have failed or patients whose treatments are considered ineffective or intolerable
Patients with non-colorectal cancers are eligible and must be progressing at the time of the screening assessment and for whom no other treatment exists
Patients with at least one (1) measurable tumor, per the WHO Tumor Response Criteria - Histological or cytological documentation of cancer- ECOG Performance status 0 or 1
Life expectancy of at least 12 weeks- Adequate bone marrow, liver and renal function (assessed by the following laboratory requirements):
Hemoglobin >/= 9.0 g/dl - Absolute neutrophil count (ANC) >/=1,500/mm3
Platelet count = 100,000/µl3
Total bilirubin </=1.0 times the upper limit of normal unless due to Gilbert's
ALT and AST </= 2.5 x upper limit of normal. (For patients with hepatic involvement of their cancer, ALT and AST < 5.0 x upper limit of normal)
PT-INR/PTT < 1.5 x upper limit of normal. (Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.

In addition, these patients must be monitored with weekly coagulation assessments throughout the Run-in Period)- Serum creatinine < 1.5 x upper limit of normal

Exclusion criteria

Patients who meet the following criteria at the time of screening will be excluded:
Non small cell lung cancer, hepatocellular cancer, CML and AML
Serious cardiac arrhythmia
Congestive Heart Failure (NYHA Class 3 or 4)
Active of coronary artery disease or ischemia
Active acute infections that could be worsened by anticancer therapy or interfere with this study
Known HIV infection
Metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry
Patients currently receiving medication (steroid or anticonvulsant therapy) for seizure disorder
History of organ allograft- Previous or concurrent cancer that is distinct from the cancer being evaluated in this study. Several situations are excluded, including cervical carcinoma in situ, adequately treated basal cell carcinoma, superficial bladder tumors or any cancer definitively treated greater than 3 years
Anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to the first dose of study drug
Radiotherapy during the study or within 3 weeks prior to the first dose of study drug
Bone marrow transplant or stem cell rescue within 4 months prior to the first dose of study drug
Biological response modifiers, such as G-CSF within 3 weeks prior to study entry
Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study
Investigational drug therapy outside of this trial during or within 4 weeks prior to the screening assessment
Any previous exposure to a Ras pathway inhibitor
Pregnant or breast feeding patients. Women of child bearing potential must have a negative pregnancy test. Adequate barrier contraception will be required for both male and female patients during the entire course of the trial
Substance abuse, medical or psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
Known or suspected allergy to the investigational agent or any agent given in association with the trial
Any condition that is unstable or could jeopardize the safety of the patient and/or their compliance in the study