None listed
Conditions
Interventions
Sunitinib will be administered orally in a continuous daily dosing regimen, with an initial dose of 37.5 mg. Prednisone (or prednisolone, if prednisone is not commercially available) will be administered continuously at a dose of 5 mg orally, IDB,
Group name:Arm B Type of group
Oral placebo will be administered in a continuous daily dosing regimen and prednisone (or prednisolone, if prednisone is not commercially available) will be administered continuously at a dose of 5 mg orally, IDB
Sponsors
PFIZER S.A.,
Eligibility
Sex/Gender
Male
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: • Histological or cytologically confirmed prostate adenocarcinoma. • Metastatic hormone-refractory prostate cancer (refractory to androgenic ablation). Patients should have ongoing surgical or chemical castration, with a baseline testosterone level 1500 / pL, Platelets> 100,000 / pL, Hemoglobin> 9.0 g / dL, Serum creatinine lower limit of normal institutional value (LLN), as observed in a cardiac gammagram (MUGA) or echocardiogram. • Informed consent document, signed and dated, indicating that the patient (or his legal representative) has been informed of all relevant aspects of the study before enrollment. • Desire and ability to meet scheduled visits, treatment plans, laboratory tests and other study procedures, including filling out questionnaires about the results reported by the patient and a diary about the use of pain relievers.
Exclusion criteria
Exclusion criteria: • Previous treatment with sunitinib (in any clinical context) and / or more than one previous chemotherapy regimen in the context of metastatic disease treatment. • Chemotherapy in the 3 weeks prior to the date of the first dose. • Radioisotope therapy with strontium-89 or sama in the 12 weeks prior to the date of the first dose. • Radiation therapy (including palliative radiotherapy for metastatic lesions) in the previous 2 weeks or major surgery (eg, open abdominal, pelvic, thoracic, orthopedic or neurosurgery surgery) in the 4 weeks prior to the date of the first dose • Current treatment in another therapeutic clinical study • Imminent complication due to bone metastasis (fracture and / or spinal compression). Stable fracture and / or spinal compression Properly treated or stabilized is allowed. • Presence of ongoing urinary obstruction (eg, urinary retention, hydronephrosis) that requires medical intervention. Properly treated urinary obstruction is allowed. • Hemorrhage of grade> 3 in the 4 weeks prior to the date of the first dose 9. Cardiac dysrhythmias in progress of grade> 2. • Hypertension that cannot be controlled by medications (> 150/100 mmHg despite optimal medical treatment). • Ongoing treatment with therapeutic doses (with therapeutic levels of INR) of coumarin derivatives or oral anti-vitamin K agents. • Diagnosis of a second cancer in the last 3 years, except for basal cell carcinoma, squamous cell skin cancer, fully treated stage I carcinoma or carcinoma in situ that has been adequately treated, with no evidence of recurrent disease for 12 months . • Any of the following manifestations in the 6 months prior to the administration of the study drug: severe / unstable angina, myocardial infarction, symptomatic congestive heart failure, pulmonary embolism, stroke or transient ischemic attack. • History of known brain metastases (cranial metastases allowed), spinal cord compression, carcinomatous meningitis or leptomeningeal disease. • Infection known by the human immunodeficiency virus (HIV). • Another severe acute or chronic medical or psychiatric condition or laboratory alteration that could impact, at the discretion of the investigator, on the risk associated with participation in the study or administration of the study drug or that, in the opinion of the investigator, could cause that the patient is inappropriate to enter the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:OS is the duration from randomization to death. For participants who were alive, overall survival was censored at the last contact. OS (in months) calculated as (date of death minus [-] date of randomization plus [+] 1) divided (/) 30.4. Measure:Overall Survival (OS) Timepoints:Baseline up to 32 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:PFS is the period from randomization until disease progression or death on study. PFS is censored on the date of last tumor assessment documenting absence of progressive disease. PFS (weeks) calculated as (first event date - randomization date + 1)/7.02 Measure:Progression-Free Survival (PFS) Timepoints:Baseline, every 8 weeks up to 123 weeks ; Outcome name:OR defined as the percent (%) of participants with confirmed Complete Response (CR) (disappearance of all target lesions) or Partial Response (PR) (>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions) according to Response Evaluation Criteria in Solid Tumors (RECIST), relative to the full analysis population. Confirmed responses were those that persist on repeat imagining study >= 4 weeks after initial documentation of response. Measure:Percent of Participants With Objective Response (OR) Timepoints:Baseline, every 8 weeks up to 123 weeks ; Outcome name:Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cause - the date of the first CR or PR that was subsequently confirmed plus 1 divided by 7.02. DR calculated for the subgroup of participants with a confirmed objective tumor response Measure:Duration of Response (DR) Timepoints:Baseline, every 8 weeks up to 123 weeks ; Outcome name:Pain severity recorded on a numerical scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores indicated greater level of pain. The pain score for each cycle averaged for the 7 days. Measure:Change From Baseline in Pain Severity Timepoints:Day 1 through Day 7 every 28 days (every cycle) up to 29 months ; Outcome name:FACT-P is a validated, self-admini | — |
Countries
Australia, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Israel, Italy, Korea South, Poland, Portugal, Slovakia, Spain, Sweden, Taiwan, United Kindgdom, United States
Contacts
Public ContactEDUARDO ALVARADO
PFIZER S.A.
Outcome results
None listed