Advanced prostate cancer
Conditions
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Signed written informed consent according to institutional guidelines 2) Target population a) Men = 18 years of age b) Histologically or cytologically proven advanced prostate carcinoma c) Metastatic disease documented by transaxial imaging or radionuclide bone scan. d) Progressive disease based on PSA with a minimum of 3 consecutive rising levels, with an interval of > 1 week between each determination. The last determination must have a minimal value of 5 ng/mL and be determined within two weeks prior to registration. 3) Castrate levels of serum testosterone (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Sex and Reproductive Status 1) Women 2) Men whose sexual partners are WOCBP, who are unwilling or unable to use an acceptable method to avoid pregnancy of his partner for the entire study period and for at least 12 weeks after completion of study medication Target Disease Exceptions 3) Symptomatic CNS metastases Medical History and Concurrent Diseases 4) Medical condition which could significantly increase the risk of toxicity, including: a) Clinically-significant coagulation or platelet function disorder b) Infection requiring intravenous antibiotics c) Ongoing or recent gastrointestinal bleeding d) Clinically-significant cardiovascular disease, including myocardial infarction or ventricular tachyarrhythmia within 6 months, prolonged QTc>450 msec., Ejection Fraction (EF) 5 years is acceptable. 7) Inability to take or absorb oral medication for any reason 8) Inability to understand the potential risks and provide informed consent Prohibited Therapies and/or Medications 9) Bisphosphonate use may not commence within 3 weeks of study entry. Subjects with current bisphosphonate use fulfilling study entry criteria may continue bisphosphates during study. 10) See Protocol section 6.4.1 for specific details: a) potent CYP3A4 inhibitors b) QTc prolonging agents strongly associated with Torsades de Pointes arrhythmia Other Exclusion Criteria 11) Prisoners or subjects who are compulsorily detained
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1. To describe PSA response rate, and changes in PSA velocity and PSA doubling time of subjects receiving dasatinib. 2. To describe tumor response, bone scan response, duration of PSA response, and time to disease progression 3. To assess safety and tolerability of dasatinib in combination with an LHRH agonist as a function of dose, and identify a well-tolerated dose in this setting. 4. To assess changes in markers of bone loss, serum alkaline phosphatase (bone-specific isoenzyme) and urinary N-telopeptide during dasatinib treatment 5. To obtain pharmacokinetic data. 6. To assess disease related symptoms using the 8 item FACT Advanced Prostate Symptom Index (FAPSI-8).;Primary end point(s): Efficacy: The primary study endpoint is response (a composite of PSA response, radiographic response, and bone scan response) as an indication of anti-tumor efficacy. The response rate is defined as the proportion of all treated subjects that achieve response. The PSA response rate is defined as the proportion of treated subjects who achieve and maintain a 50% reduction in PSA from baseline. Main secondary efficacy endpoints are responses by bone scan or other individually-appropriate radiographic measure, duration of response, and time to disease progression. Secondary measures include measures of bone metabolism, including urinary N-telopeptide and bone-isoenzyme alkaline phosphatase. PSA velocity and doubling time will be described. Response outcomes based on each abnormal parameter of the disease (PSA, measurable disease, and bone scan) will be reported independently. Safety/tolerability: Safety and tolerability is a main secondary endpoint. Adverse events will be assessed continuously and graded according to NCI Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v. 3.0) for all treated subjects. Disease related symptoms will be evaluated using the 8-item FACT (Functional Assessment of Cancer Therapy) Advanced Prostate Symptom Index (FAPSI- | — |
Countries
France, Italy
Outcome results
None listed