Clinical trial NCT00079612: Study of Nexavar (Sorafenib, BAY 43-9006) in Patients With Advanced Refractory Cancer
Official title: Randomized Discontinuation Study of BAY 43-9006 in Patients With Advanced Refractory Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Renal Cell
Keywords: Renal Cell Cancer
RCC
Cancer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Amgen
First posted: 2004-03-11
Enrollment: 501
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of progressions post randomization to placebo or sorafenib
timeFrame: 12 weeks post randomization
Secondary outcomes:
measure: Time to progression
timeFrame: Until Progression occurs
measure: Duration of objective tumor response
timeFrame: Time from initial Response to documented Tumor Progression
measure: Overall survival time
timeFrame: At the End-of-Study visit
Other outcomes:
Locations:
city: Chicago
country: United States
state: Illinois
city: Philadelphia
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: London
country: United Kingdom
state: Greater London
city: Glasgow
country: United Kingdom
state: Strathclyde
city: Sutton
country: United Kingdom
state: Surrey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: