Metastatic hormone refractory prostate cancer MedDRA version: 9.1 Level: LLT Classification code 10062904 Term: Hormone-refractory prostate cancer
Conditions
Interventions
Product Name: not applicable
Product Code: PHA-739358
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: not available
CAS Number: 827318-97-8
Current Sponsor code: PHA-73
Sponsors
Nerviano Medical Sciences S.r.l.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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 /= 1,500/mm3 (>/= 1.5 x 1000000000/L); . Platelets >/= 100,000/mm3 (>/= 100 x 1000000000/L); . Hemoglobin >/= 10.0 g/dL; . Serum Creatinine /= 3.0 g/dL; . Total Serum Bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the antitumor activity of PHA-739358 administered as IV infusion according to two different dose schedules in metastatic HRPC patients progressing on standard, docetaxel-based, 1st-line chemotherapy for HRPC based on PSA response rate and to select the best dose schedule for further investigation.;Secondary Objective: - To further assess the antitumor activity of PHA-739358 based on objective tumor response, PSA reduction, PSA velocity, and time related end-points (duration of PSA response, progression-free survival), - To assess PHA-739358 palliative effects on tumor pain, - To assess the safety and tolerability of the two PHA-739358 schedules tested in the target population. ;Primary end point(s): PSA response rate within the first three months of treatment, defined according to the recommendations from the Prostate-Specific Antigen Working Group, i.e. proportion of patient achieving at least a 50% PSA decline from baseline confirmed by a second PSA value, 4 or more weeks later. | — |
Countries
France, Italy, Netherlands
Outcome results
None listed