Phase II Study of Dasatinib BMS-354825 for Androgen-Deprived Progressive Prostate Cancer - ND

• Conditions: Advanced prostate cancer.; MedDRA version: 9.1Level: LLTClassification code 10029096Term: Neoplasm prostate

• Registration Number: EUCTR2006-002205-31-IT
• Lead Sponsor: Bristol Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

Signed written informed consent according to institutional guidelines Target population Men 18 years of age Histologically or cytologically proven advanced prostate carcinoma Metastatic disease documented by transaxial imaging or radionuclide bone scan. 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. Castrate levels of serum testosterone 61500; 61472;30 ng/dL determined within two weeks prior to starting treatment. No prior chemotherapy, adjuvant, or neo-adjuvant chemotherapy in the prostate cancer setting. Patients who have received an anti-androgen as part of their prior hormonal therapy must have shown progression of disease off of the anti-androgen prior to enrollment. The first of the three consecutive PSA measurements confirming progression should be dated at least 6 weeks after bicalutamide withdrawal and 4 weeks for other antiandrogens. At least 6 weeks must have elapsed for isotope therapy 12 weeks for Strontium-89 or immunotherapy , prior to beginning protocol therapy. At least 4 weeks must have elapsed from major surgery. Toxicities related to prior therapy must either have returned to 61472; CTC Grade 1, baseline or deemed irreversible. Adequate organ function as defined by the following laboratory tests Hepatic enzymes AST, ALT , Total bilirubin all CTC Grade 0-1 Serum Calcium 61619; the lower limit of normal Serum Potassium, Magnesium, and Phosphate all CTC Grade 0-1 Creatinine CTC Grade 0-2 Hemoglobin, Neutrophil count, Platelets, PT, PTT all CTC Grade 0-1 ECOG performance status 0-2 Appendix 1 . Life expectancy at least 3 months. Patient must be available for follow-up.
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

Exclusion Criteria

Sex and Reproductive Status 1 Women Target Disease Exceptions 2 Symptomatic CNS metastases Medical History and Concurrent Diseases 3 Medical condition which could significantly increase the risk of toxicity, including a Clinically-significant coagulation or platelet function disorder subjects who have never experienced surgical or dental bleeding challenge should also be tested for clinically significant von Willebrand s disease. 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. Fridericia correction , Ejection Fraction EF 40 or major conduction abnormality unless a cardiac pacemaker is present e Requirement for prohibited concomitant therapy for details, see section 6.4.1 . 4 Any prior or ongoing anti-neoplastic medical therapy or immunotherapy for prostate cancer other than primary androgen deprivation agents and anti-androgens e.g., cytotoxic chemotherapy, mitoxantrone, estramustine, or docetaxel; adrenal androgen production inhibitors aminoglutethamide or ketoconazole; glucocorticoids in cytotoxic doses and schedules; vaccine therapy. 5 Any other concurrent malignancy other than in situ carcinoma of skin. History of malignancy other than prostate cancer that has been in complete remission 5 years is acceptable. 6 Inability to take or absorb oral medication for any reason 7 Inability to understand the potential risks and provide informed consent Prohibited Therapies and/or Medications 8 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. 9 See section 6.4.1 for specific details a potent CYP3A4 inhibitors b QTc prolonging agents strongly associated with Torsades de Pointes arrhythmia c non-reversible platelet inhibiting agents Other Exclusion Criteria 10 Prisoners or subjects who are compulsorily detained involuntarily incarcerated for treatment of either a psychiatric or physical e.g., infectious disease illness must not be enrolled into this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified