Prostate Cancer
Conditions
Brief summary
This is a Phase I, multicenter, open-label, dose-escalation study of DSTP3086S administered as a single agent by intravenous (IV) infusion to patients with metastatic Castration-Resistant Prostate Cancer (CRPC).
Interventions
DRUGDSTP3086S
DSTP3086S administered intravenously
Sponsors
Genentech, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 * Life expectancy of at least 12 weeks * Histologic documentation of adenocarcinoma of the prostate * Surgical castration or ongoing use of gonadotropin-releasing hormone agonists with confirmed castrate levels of testosterone * Metastatic progressive CRPC defined as progressive disease despite surgical castration or ongoing use of gonadotropin-releasing hormone agonists with confirmed castrate levels of testosterone * For patients in the dose-expansion cohort of the study, not more than two prior lines of cytotoxic chemotherapy in the metastatic setting * Evaluable or measurable disease * Documented willingness to use an effective means of contraception
Exclusion criteria
* Anti-tumor therapy, including chemotherapy, biologic, experimental, or hormonal therapy, or radiotherapy within 4 weeks prior to Day 1, with the following exceptions: maintenance hormonal therapy for metastatic prostate cancer and palliative radiation to bone metastases within 2 weeks prior to Day 1 * Major surgical procedure within 4 weeks prior to Day 1 * Known active bacterial, viral, fungal, mycobacterial, or other infection (including HIV and atypical mycobacterial disease, but excluding fungal infections of the nail beds) * Ongoing corticosteroid use with \> 10 mg of daily prednisone or equivalent * Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy. Patients who are receiving bisphosphonate therapy specifically to prevent skeletal events and who do not have a history of clinically significant hypercalcemia are eligible. * History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins) * Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis * Untreated or active central nervous system (CNS) metastases. Patients with a history of treated CNS metastases are eligible, provided that they meet all of the following criteria: evaluable or measurable disease outside the CNS, radiographic demonstration of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study, and screening CNS radiographic study is \>/= 8 weeks since completion of radiotherapy and \>/= 4 weeks since the discontinuation of corticosteroids and anticonvulsants * Dose expansion cohort (B): no prior chemotherapy is allowed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and nature of dose-limiting toxicities (DLTs) | Days 1-21 |
Secondary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve | Up to 1 year |
| Maximum and minimum concentrations | Up to 1 year |
| Clearance | Up to 1 year |
| Half-life | Up to 1 year |
| Volume of distribution | Up to 1 year |
Countries
United States
Outcome results
None listed