Previously Treated Castrate Resistant Prostate Cancer MedDRA version: 9.1 Level: LLT Classification code 10060862 Term: Prostate cancer
Conditions
Interventions
Product Name: AMG 102
Product Code: AMG 102
Pharmaceutical Form: Intravenous infusion
Current Sponsor code: AMG 102
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: up to
Concentr
Sponsors
Amgen Inc
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Disease-related • Pathologically confirmed adenocarcinoma of the prostate • Radiographic evidence of metastatic disease • Progressive disease meeting at least one of the following criteria: 1) a sequence of at least 2 rising PSA values measured at a minimum of 1 week apart with a 2 ng/mL minimum starting value, or 2) progression according to RECIST criteria for measurable lesions, or 3) appearance of 2 or more new lesions on bone scan. • History of prior taxane-based chemotherapy for metastatic prostate cancer; no more than one prior chemotherapy regimen for CRPC is allowed (estramustine will be considered as chemotherapy) • ECOG Performance status 0 or 1 • Life expectancy = 3 months Demographic Men = 18 years of age Laboratory • Castrate levels of serum testosterone (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Disease-related • Treatment with external beam radiotherapy = 14 days before enrollment or radiopharmaceutical =8 weeks • = 4 weeks since receipt of most recent prior chemotherapy, non-GnRH analog hormonal therapy (except for continuing corticosteroids) or other systemic therapy to treat prostate cancer and Grade 1 • Presence of peripheral edema > Grade 2 • Known proteinuria > 1 gram/day (subjects with >2+ protein on screening urinalysis require a quantitative evaluation of urine protein) • Any clinically significant medical condition other than cancer, including cardiovascular disease or COPD, which in the opinion of the investigator would interfere with the safe delivery of study treatment or increase risk of toxicity • History of any medical condition that in the opinion of the investigator, may increase the risks associated with study participation or study treatments or may interfere with the conduct of the study or interpretation of study results • Known positive test for HIV, hepatitis C, chronic or active hepatitis B • Serious or non-healing wound • Unable to begin protocol specified treatment within 7 days after enrollment • Other investigational procedures are excluded. • Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s). • Treated previously with c-Met or HGF targeted therapy • Subject is not using adequate contraceptive precautions. • Subject has known sensitivity to any of the products to be administered during dosing. • Subject will not be available for follow-up assessment. • Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase 1b (Open label): • To identify safe dose levels of AMG 102, up to 15 mg/kg Q3W, to combine with mitoxantrone and prednisone (MP) Phase 2 (Double-blind): • To estimate with adequate precision the effect of the addition of AMG 102 to MP, compared with placebo plus MP, as assessed by the hazard ratio (HR) for overall survival (OS) of previously treated subjects with castrate-resistant prostate cancer (CRPC);Secondary Objective: Phase 1b • To evaluate the incidence of adverse events, abnormal laboratory values not defined as dose limiting toxicities (DLTs), and anti-AMG 102 antibody formation. • To evaluate the pharmacokinetics (PK) of AMG 102 (Cmax and Cmin). Phase 2 • To evaluate the effect of the addition of AMG 102 to MP on progression-free survival (PFS), percentage changes in prostate-specific antigen (PSA) level, PSA response rates, RECIST response rates, patient reported outcomes including pain, incidence of adverse events, laboratory abnormalities, and anti-AMG 102 antibody formation. • To evaluate the PK (Cmax and Cmin) of AMG 102, and assess the impact of co-administration of AMG 102 on the PK of mitoxantrone in a sub-group of subjects at selected sites.;Primary end point(s): Phase 1: To identify a safe dose level of AMG 102, up to 15 mg/kg Q3W, to combine with mitoxantrone and prednisone (MP) Phase 2: To estimate with adequate precision the effect of the addition of AMG 102 to MP, compared with placebo plus MP, as assessed by the hazard ratio (HR) for overall survival (OS) of previously treated subjects with castrate-resistant prostate cancer (CRPC) | — |
Countries
Czech Republic, Finland, France, Netherlands, Sweden, United Kingdom
Outcome results
None listed