Androgen-independent metastatic prostate cancer MedDRA version: 9.1 Level: LLT Classification code 10036909 Term: Prostate cancer metastatic
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Pathologically confirmed diagnosis of adenocarcinoma of the prostate - Must have evidence of androgen-independent metastatic prostate cancer (documented bone or soft tissue metastases by bone scans, computed tomography [CT] scans, or Magnetic Resonance Imaging [MRI]) with evidence of progression defined as:(A) PSA progression; (B) Clinical and/or radiographic progression. - Must have had either an orchiectomy or have castrate level of testosterone (5 years with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or stage Ta transitional cell carcinoma of the bladder - At least 18 years of age - Have given informed consent - Have an estimated life expectancy of at least 12 weeks 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
Exclusion criteria: - Pretreated with any cytotoxic regimen for advanced prostate cancer and prior chemotherapy for any indication within 2 years of study entry - Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry - Receive concurrent administration of any other systemic anticancer therapy except LHRH agonist - Are unable to discontinue the use of carbamazepine, phenobarbital, phenytoin, or natural herbal medications (for example, PC-SPES, Saw Palmetto, St. John's Wort) at least 14 days prior to enrollment - Have serious concomitant disorder, including active bacterial, fungal, or viral infection (at the discretion of the investigator) - Have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or severe heart disease, as defined by the New York Heart Association Class III or IV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the objective response rate of enzastaurin given in combination with docetaxel and prednisone followed by enzastaurin maintenance therapy in patients with HRPC during first-line therapy versus placebo plus docetaxel and prednisone followed by placebo as maintenance. An objective response rate is assessed via objective lesion response and a 50% decline from baseline in PSA. ;Secondary Objective: The secondary objectives of the study are the following: to assess rate of 3-month PSA level decline of at least 30% in both treatment arms; to assess PSA velocity at 2 and 3 months in both treatment arms; to assess the following efficacy variables in both treatment arms (progression-free survival (PFS) time, overall survival (OS), and duration of response for responding patients); to assess the safety and adverse event profile in both treatment arms; to assess biomarkers relevant to enzastaurin and the disease state, as well as their correlation to clinical outcome; to characterize the pharmacokinetics (PK) of enzastaurin using intensive sampling in Part 1 (safety lead-in) and a sparse sampling strategy in randomized Part 2 of the trial; and to determine if PK of docetaxel is altered when administered in combination with enzastaurin. ;Primary end point(s): The primary end point of this study is to compare the objective response rate of enzastaurin given in combination with docetaxel and prednisone followed by enzastaurin maintenance therapy versus placebo plus docetaxel and prednisone followed by placebo as maintenance. | — |
Countries
Germany, Italy
Outcome results
None listed