A Phase II Study of PHA-739358 in Patients with Metastatic Hormone Refractory Prostate Cancer. - not available
- Conditions
- Metastatic hormone refractory prostate cancerMedDRA version: 9.1Level: LLTClassification code 10062904Term: Hormone-refractory prostate cancer
- Registration Number
- EUCTR2006-006136-21-FR
- Lead Sponsor
- erviano Medical Sciences S.r.l.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 118
1. Adult (age >/= 18 years) male patients.
2. Histologically confirmed diagnosis of adenocarcinoma of the prostate.
3. Metastatic (stage D3 according to Jewett Staging System).
4. Hormone-refractory disease, progressing after 1st-line docetaxel-based chemotherapy. For patients with measurable disease, progression will be defined by RECIST criteria. For patients without any measurable disease, appearance of new bone lesions at bone scan and PSA progression, according to recommendations from the Prostate-Specific Antigen Working Group, will be required.
5. Patients receiving corticosteroids requested for concomitant disease other than HRPC should continue treatment at the same dose.
6. Patients receiving bisphosphonate therapy must have been on stable doses for at least 4 weeks with stable symptoms prior to enrollment.
7. Patients who have not undergone surgical castration must continue on primary androgen deprivation with LHRH analogue, if any, and testosterone must be < 50 ng/dL.
8. Prior radiotherapy is allowed provided that no more than 25% of bone marrow reserve has been irradiated and a minimum of 4 weeks have elapsed between the end of prior radiotherapy and the entry into the trial.
9. ECOG performance status 0-2.
10. Life expectancy of at least 3 months.
11. Resolution of all acute toxic effects (excluding alopecia) of any prior surgery, radiotherapy, radio-surgery or chemotherapy to NCI CTC (Version 3.0) Grade
12. Baseline laboratory values fulfilling the following requirements:
. Absolute Neutrophils Count (ANC) >/= 1,500/mm3 (>/= 1.5 x 1000000000/L);
. Platelets >/= 100,000/mm3 (>/= 100 x 1000000000/L);
. Hemoglobin >/= 10.0 g/dL;
. Serum Creatinine . Serum Albumin >/= 3.0 g/dL;
. Total Serum Bilirubin Liver Transaminases (AST/ALT) . Alkaline Phosphatase (ALP)
13. Signed and dated informed consent indicating that the patient is aware of the neoplastic nature of his disease and has been informed of the procedures to be followed, the experimental nature of the therapy, potential benefits, side effects, discomforts, risks, and alternative treatments.
14. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study indications or 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
1. Current enrollment in another therapeutic clinical trial.
2. Use of other investigational drugs (drugs not marketed for any indication) within 30 days prior to treatment.
3. More than one prior chemotherapy line.
4. Known brain or leptomeningeal disease (baseline computerized tomography [CT] or Magnetic Resonance Imaging [MRI] scan of the brain required only in case of clinical suspicion of central nervous system metastases.
5. Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or superficial bladder cancer, or any other cancer from which the patient has been disease-free for 5 years or greater.
6. Prior treatment with radiopharmaceuticals (e.g. Strontium-89, Samarium-153) within 8 weeks prior to enrollment.
7. Major surgery, within 4 weeks or not fully recovered prior to Day 1.
8. Male patients must agree to have no intention to father a child during the study and in the following 3 months after the end of the treatment.
9. Uncontrolled hypertension with blood pressure exceeding 160/100 mmHg (Stage 2 hypertension according to the JNC 7/ NIH USA 2003 guideline).
10. Any of the following in the past 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis.
11. Cardiac dysrhythmias Grade >/= 2 according to NCI CTCAE version 3.0.
12. Known active infections, including HIV positivity.
13. History of allergic reactions to a similar structural compound, biological agent, or formulation.
14. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.
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