Randomized phase II study of sorafenib plus bicaluamide vs. placebo plus bicalutamide in castration-resistant asymptomatic or mildly symptomatic metastatic prostate cancer patients who had orchiectomy or are receiving a LHRH analogue
- Conditions
- Metastatic Prostate CancerMedDRA version: 9.1Level: LLTClassification code 10062904Term: Hormone-refractory prostate cancerMedDRA version: 9.1Level: LLTClassification code 10036909Term: Prostate cancer metastatic
- Registration Number
- EUCTR2008-006022-34-GB
- Lead Sponsor
- Bayer HealthCare AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 250
•Age = 18 years.
•Histological or cytological documentation of adenocarcinoma of the prostate
•Asymptomatic or mildly symptomatic prostate cancer patients (non-opiate-requiring pain)
•Progression of disease despite castrate levels of testosterone and adequate therapy with LHRH analogues or after orchiectomy, demonstrated by rising PSA in plasma on at least 2 consecutive measurements taken at least 7 days apart. The last measurement must be =2 ng/mL
•Evaluable bone, lymph node (=2 cm) or soft tissue metastases
•Ongoing treatment with LHRH analogues unless patient had an orchiectomy
•Serum plasma testosterone < 50 ng/dl at screening
•ECOG Performance Status of 0 or 1
•Life expectancy of at least 12 weeks.
•Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 14 days prior to the start of the study treatment [All laboratory assessments will be performed by a central laboratory (see separate laboratory manual for full details)]:
•Hemoglobin = 9.0 g/dl
•Absolute neutrophil count (ANC) =1,500/mm3
•Platelet count = 100,000/µl
•Total bilirubin = 1.5 times the upper limit of normal (ULN)
•ALT and AST = 2.5 x ULN (= 5 x ULN for patients with liver involvement of their cancer)
•PT-INR/PT <1.5 x ULN. 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. For patients on warfarin, close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement before the study treatment was started, as defined by the local standard of care.
- Patients being anticoagulated for deep vein thrombosis and/or pulmonary embolus occurring within 12 months of the start of treatment are excluded from this trial.
•Serum creatinine = 1.5 x ULN
•Men enrolled in this trial must use adequate barrier birth control measures while in the study and for 3 months after the completion of the study.
•Signed informed consent must be obtained prior to any study specific procedures.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Excluded medical conditions:
•History of cardiac disease;
•congestive heart failure >New York Heart Association (NYHA) class 2
•active coronary artery disease (myocardial infarction more than 6 months prior to start of study treatment is allowed)
•cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
•uncontrolled hypertension (defined as blood pressure = 160 mmHg systolic and/or = 90 mmHg diastolic on medication)
•History of HIV infection or chronic hepatitis B or C
•Active clinically serious infections (> grade 2 National Cancer Institute - common terminology criteria for adverse event [NCI-CTCAE] version 3.0)
•Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of start of study treatment and is clinically stable with respect to the tumor at the time of start of study treatment. Also, the patient must not be undergoing acute steroid therapy or taper therapy (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies).
•Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
•History of organ allograft
•Patients with evidence or history of bleeding diathesis
•Deep vein thrombosis and/or pulmonary embolus within 12 months of the start of study treatment
•Delayed healing of wounds, ulcers or bone fractures
•Patients with pre-existing thyroid abnormality whose thyroid function cannot be maintained within the normal range with medication
•Patients undergoing renal dialysis
•Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer that was curatively treated more than 3 years before the start of study treatment
•Any condition that is unstable or could jeopardize the safety of the patient and his compliance in the study
•Patients unable to swallow oral medications. This applies to patients with severe obstruction of upper gastrointestinal tract that requires gavage.
•Known hypersensitivity to either NEXAVAR®, to the constituents of the placebo tablets used in this study or to the bicalutamide-containing drug
•Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results
Excluded therapies and medications, previous and concomitant:
•Antiandrogen therapy within the last 6 weeks prior to the start of study treatment
•Prior sorafenib therapy
•Any prior cytotoxic chemotherapy for advanced disease (patients that had received adjuvant or neoadjuvant chemotherapy are allowed to participate in the trial), or therapy with receptor tyrosine kinase inhibitors
•Investigational drug therapy not included in this protocol during the study, or which is taken within 4 weeks or 5 half-lives before the start of the study treatment or inadequate recovery from any toxic effects of such therapies
•Major surgery during the last 4 weeks prior to the start of study treatment
•Autologous bone marrow transplant or stem cell rescue during the last 4 months prior to the start of study treatment
•Use of biologic response modifiers, such as granylocyte colony-stimulating factor (G-CSF), within 3 weeks after the start of study treatment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method