metastatic castrate resistant prostate cancer MedDRA version: 14.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: LLT Classification code 10062904 Term: Hormone-refractory prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Custirsen 20mg/ml concentrate for solution for infusion
Product Code: OGX-011, TV-011
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: custirsen
CAS Number
Sponsors
Teva Pharmaceutical Industries, Ltd
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Subjects must meet ALL of the following criteria to be eligible for inclusion into the study: 1.Age = 18 years on the date of consent. 2.Histological or cytological diagnosis of adenocarcinoma of the prostate. 3.Metastatic disease on chest, abdominal, or pelvic CT and/or bone scan. 4.Systemic chemotherapy indicated due to progression while on or after androgen ablative therapy defined as: a.Progressive measurable disease: at least a 20% increase in the sum of the longest diameters of measurable lesions over the smallest sum observed –or the appearance of one or more new lesions as assessed by CT scan during hormone ablation treatment. Measurable lesions are nodal or visceral soft-tissue lesions with nodal lesions = 20 mm in diameter or visceral/soft-tissue lesions = 10 mm in diameter (see Section 6.3.1.1). OR b.Bone Scan Progression: appearance of 2 or more new lesions on bone scan during hormone ablation treatment. OR c.Increasing serum PSA level: Two consecutive increases in PSA levels documented over a previous reference value obtained at least one week apart are required. If the third PSA value is less than the second, an additional fourth test to confirm a rising PSA is acceptable. A minimum starting value of 5.0 ng/mL is required for study randomization. NOTE: Androgen ablative therapy may have included either medical or surgical castration. 5.Baseline laboratory values as stated below: a.Creatinine = 1.5 x upper limit of normal (ULN). b.Bilirubin = 1.1 x ULN (unless elevated secondary to conditions such as Gilbert’s disease). c.SGOT(AST) and SGPT(ALT)=1.5xULN d.Castrate serum testosterone level (=65 years) yes F.1.3.1 Number of subjects for t
Exclusion criteria
Exclusion criteria: Subjects meeting ANY of the following exclusion criteria will NOT be eligible for inclusion into the study: 1.Received any other cytotoxic chemotherapy as treatment for prostate cancer 2.Received any cycling, intermittent or continuous hormonal treatment 28 days prior to randomization with the exception of the continuous GnRH analogues required in Inclusion Criteria #6. 3.Participated in a prior clinical study evaluating custirsen. 4.History of or current documented brain metastasis or carcinomatous meningitis, treated or untreated. (Brain imaging for asymptomatic patients is not required.) 5.Current symptomatic cord compression requiring surgery or radiation therapy. (Once successfully treated and there has been no progression, patients are eligible for the study.) 6.Active second malignancy(except non melanomatous skin or superficial bladder cancer) defined as requiring anticancer therapy or at high risk of recurrence during the study 7.Uncontrolled medical conditions such as heart failure, myocardial infarction, uncontrolled hypertension, stroke or treatment of a major active infection within 3 months of randomization, as well as any significant concurrent medical illness that in the opinion of the Investigator would preclude protocol therapy. 8.Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device. Concomitant participation in observational studies is acceptable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To ascertain whether the survival time distribution for patients randomized to the investigational arm is consistent with longer survival as compared to patients randomized to the control arm.;Secondary Objective: To compare the arms with respect to the proportion of patients having a milestone Day 140 status of alive without event (within the window of Day 125-155 post randomization). An event is having disease progression or death on or before Day 140. NOTE: Day 140, as measured from the date of randomization, will occur normally after Cycle 6 (prior to Cycle 7) study treatment. However, the milestone Day 140 disease assessment must be completed within the inclusive window of Day 125 to Day 155 post-randomization, regardless of the timing of Cycle 6 treatment (e.g., if treatment scheduling at any time has been delayed).;Primary end point(s): Primary Efficacy Endpoint: Survival time distribution: Survival will be assessed for each patient from the date of randomization to the date of death from any cause. ;Timepoint(s) of evaluation of this end point: Survival will be assessed for each patient from the date of randomization to the date of death from any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The status of each patient at approximately Day 140 (window of Day 125-155) post-randomization is to be recorded as alive without event or not (binary outcome) in order to compute the arm-specific proportion of patients who are alive without event at approximately Day 140.;Timepoint(s) of evaluation of this end point: Approximately at Day 140. | — |
Countries
Belgium, Canada, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Netherlands, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trial Information Desk
Teva Pharma GmbH
Outcome results
None listed