Metastatic Prostate Cancer MedDRA version: 9.1 Level: LLT Classification code 10062904 Term: Hormone-refractory prostate cancer MedDRA version: 9.1 Level: LLT Classification code 10036909 Term: Prostate cancer metastatic
Conditions
Interventions
Trade Name: Nexavar
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: sorafenib
CAS Number: 284461-73-0
Current Sponsor code: Bay-43-9006
Concentration unit: mg milligram(s)
Concentration t
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: •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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this phase II study in castration-resistant metastatic prostate cancer patients who have had orciectomy or are receiving an LHRH analogue is to demonstrate a prolonged progression-fee survival (PFS) in the group treated with sorafenib and bicalutamide in comparison to those treated with placebo and bicalutamide.;Secondary Objective: The secondary objectives are to compare treatment groups with respect to tumor response, disease control rate, time to PSA progression, PSA response rate and time to PSA response, time to next anti-tumor therapy, overall survival, patient reported outcomes (PRO), and further evaluation of the safety and toxicity profile of the combination treatment. Secondary objectives include also an evaluation of population pharmacokinetics and biomarkers, which may relate to sorafenib's pharmacological mechanism of action and to its antitumor activity.;Primary end point(s): The primary efficacy variable in this study is PFS. It will be measured from the date of randomization until the date of radiological or clinical relapse/progression (whichever is earlier), or until death (if death occurs before progression). Patients without tumor progression or death at the time of analysis will be censored at their last date of evaluation. | — |
Countries
United Kingdom
Outcome results
None listed