A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PHASE 3 STUDY OFSUNITINIB PLUS PREDNISONE VERSUS PREDNISONE IN PATIENTS WITHPROGRESSIVE METASTATIC HORMONE-REFRACTORY PROSTATE CANCERAFTER FAILURE OF A DOCETAXEL-BASED CHEMOTHERAPY REGIMEN - ND
- Conditions
- MedDRA version: 9.1Level: LLTClassification code 10062904Term: Hormone-refractory prostate cancerprogressive mHRPC after failure of a docetaxel-based chemotherapy regimen
- Registration Number
- EUCTR2008-002158-40-IT
- Lead Sponsor
- PFIZER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 819
1. Histologically- or cytologically-confirmed adenocarcinoma of the prostate.
2. Metastatic hormone-refractory prostate cancer (refractory to androgen ablation). Patients
must have surgical or ongoing chemical castration, with baseline testosterone level <50
ng/dL.
3. Patients must have disease that has failed one prior docetaxel-based chemotherapy regimen
for the treatment of metastatic disease, defined as progression of disease on or after
treatment (docetaxel-resistant), or be considered docetaxel-intolerant (discontinued
treatment due to unacceptable toxicity, as judged by the treating physician or by the
patient). In the event both disease progression and drug intolerance are observed during
prior docetaxel-based treatment, disease progression will be considered the dominant entry
criterion.
4. Patients must have documented evidence of progressive disease
5. ECOG performance status 0 or 1.
6. Resolution of all acute toxic effects of prior therapy (except for alopecia and neuropathy)
or surgical procedure to grade ≤1 or to baseline prior to therapy.
7. Adequate organ function
8. Signed and dated informed consent document indicating that the patient (or legally
acceptable representative) has been informed of all pertinent aspects of the trial prior to
enrollment.
9. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests,
and other study procedures, including the completion of patient reported outcomes
questionnaires and an analgesic use diary.
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
1. Prior treatment with sunitinib (in any clinical setting) and/or more than one prior
chemotherapy regimen in the metastatic disease treatment setting.
2. Chemotherapy within 3 weeks of study entry.
3. Radioisotope therapy with Strontium-89 or Samarium within 12 weeks prior to study entry.
4. Radiation therapy (including palliative radiotherapy to metastatic lesion(s)) within 2 weeks
or major surgery (e.g., open abdominal, pelvic, thoracic, orthopedic or neurosurgery)
within 4 weeks prior to study entry.
5. Current treatment on another therapeutic clinical trial.
6. Impending complication from bone metastasis (fracture and/or cord compression).
7. Presence of ongoing urinary obstruction (e.g., urinary retention, hydronephrosis) requiring
medical intervention. Properly treated urinary obstruction is allowed.
8. Grade ≥3 hemorrhage within 4 weeks prior to study entry.
9. Ongoing cardiac dysrhythmias of grade ≥2.
10. Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal
medical therapy).
11. Ongoing treatment with therapeutic doses (with therapeutic INR levels) of coumarinderivatives
or oral anti-vitamin K agents.
12. Diagnosis of any second malignancy within the last 3 years, except basal cell carcinoma,
squamous cell skin cancer, stage I carcinoma fully treated, or in situ carcinoma that have
been adequately treated with no evidence of recurrent disease for 12 months.
13. Any of the following within the 6 months prior to study drug administration:
severe/unstable angina, myocardial infarction, symptomatic congestive heart failure,
pulmonary embolism, cerebrovascular accident, or transient ischemic attack.
14. Known or suspected brain metastases (skull metastases allowed), spinal cord compression,
carcinomatous meningitis, or leptomeningeal disease.
15. Known human immunodeficiency virus (HIV) infection.
16. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality
that would impart, in the judgment of the investigator, excess risk associated with study
participation or study drug administration, or which, in the judgment of the investigator
would make the patient inappropriate for entry into the trial.
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