Male adults with Hormone Refractory Prostate Cancer who have progressed, as evidenced by PSA progression or progression of measurable disease, after at least 1 prior chemotherapy regimen. MedDRA version: 8.0 Level: LLT Classification code 10062904
Conditions
Interventions
Product Name: YM155
Product Code: YM155
Pharmaceutical Form: Concentrate for solution for infusion
Current Sponsor code: YM 155
Concentr
Sponsors
Yamanouchi Europe B.V. (to be renamed Astellas Pharma Europe B.V by August 2005)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Subjects are eligible for the study if all of the following apply: 1) Written informed consent and HIPAA (U.S. sites only) authorization have been obtained. 2) Male subjects =18 years of age with histologically or cytologically confirmed prostate cancer. 3) Subject has a serum testosterone level =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects will be excluded from the study if they meet any of the following criteria: 1) Radiation therapy within 4 weeks prior to the start of YM155. 2) Prior strontium or samarium or other radioisotope therapy within 12 weeks prior to start of YM155. 3) Has metastases to the brain. 4) Concurrent anticancer therapy (chemotherapy, vaccines, immunotherapy) delivered within the last 4 weeks (6 weeks for nitrosoureas or mitomycin C, or other agents known to cause prolonged marrow suppression) except for continued use without modification of LHRH-agonists, LHRH-antagonists, and bisphosphonates initiated 4 weeks or more before the start of YM155. 5) History of other malignancy in the last 5 years. 6) Participated in a clinical study involving an investigational drug or device within 4 weeks prior to the start of YM155. 7) Known history of positive test for hepatitis B surface antigen (HbsAg) or hepatitis C antibody or history of positive test for human immunodeficiency virus (HIV) infection. 8) Had major surgery within the past 21 days prior to the start of YM155. 9) Uncontrolled intercurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, seizure disorder, or psychiatric illness/social situations that would limit compliance with study requirements. 10) Subjects with a urine protein of 2+ (grade 2) and above prior to start of YM155. 11) Has inadequate bone marrow, renal, and hepatic function as evidenced by: a. Absolute neutrophil count (ANC) = 1500/mm3 and platelet count = 100,000/mm3, b. Serum creatinine = 1.5 upper limit of normal (ULN) or calculated creatinine clearance < 60 mL/min at screening, c. Total bilirubin = 1.5 times the upper limit of normal (ULN) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 1, d. Alanine transaminase (ALT) and aspartate transaminase (AST) = 2.5 X ULN (NCI CTCAE Grade 1); if the subject has documented liver metastases and/or hepatoma, ALT and AST = 5 X ULN. 12) Any clinical condition, which, in the opinion of the investigator, would not allow safe conduct of the study. 13) Use of any alternative medications (e.g. herbal supplements) within 2 weeks prior to the start of study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of YM155 based on the percentage of subjects that obtain a PSA response. PSA response is defined as a = 50% reduction in PSA that is confirmed by a second PSA value 3 weeks apart. The reference PSA value for these decreases is the baseline PSA value. ; Secondary Objective: Secondary • To measure the percentage of PSA decrease. • To measure duration of PSA response. • To measure the time to PSA progression. • To evaluate overall survival (OS). • To measure objective tumor response (Complete Response [CR] and Partial Response [PR]) in subjects with measurable disease. • To measure change in pain based upon Memorial Pain Scale. • To evaluate progression free survival (PFS). • To evaluate safety based on clinical laboratory assessments, 12-lead ECGs, vital signs, physical examinations, and adverse events. Additional Exploratory Objectives: • To assess population pharmacokinetics of YM155. • Alpha-1-acid glycoprotein (AAG) will be obtained on all subjects at baseline and at the Final Visit/Early Termination in order to evaluate the level of AAG in relation to treatment outcomes and survival. ;Primary end point(s): • The rate of PSA response. PSA response is defined as a = 50% reduction in PSA without evidence of clinical or radiographic disease progression that is confirmed by a second PSA value 3 weeks apart. The reference PSA value for these decreases is the baseline PSA value. | — |
Countries
Czech Republic, United Kingdom
Outcome results
None listed